Chemical Pharma Report 2019

2016-17
Annual Report
2016-17
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals
Annual Report | 2016-17
Contents
1. INTRODUCTION
2. AN OVERVIEW OF PHARMACEUTICALS INDUSTRY
3. OVERVIEW OF MEDICAL DEVICES INDUSTRY
4. PRADHAN MANTRI BHARTIYA JANAUSHADHI PRARIYOJAN (PMBJP)
5. NATIONAL INSTITUTES OF PHARMACEUTICALS EDUCATION & RESEARCH (NIPERs)
6. PUBLIC SECTOR UNDERTAKINGS
7. NATIONAL PHARMACEUTICALS PRICING AUTHORITY
8. IMPLEMENTATION OF RAJBHASHA
9. GENERAL ADMINISTRATION
10. CITIZEN CENTRIC GOVERNANCE
11. INFORMATION AND COMMUNICATION TECHNOLOGY
12. ANNEXURES
Brief Contents
1. INTRODUCTION 1
1.1 Mandate of Department of Pharmaceuticals
2. AN OVERVIEW OF PHARMACEUTICALS INDUSTRY 5
2.1 Financial Performance of the Drugs and Pharmaceuticals Industry
2.2 Pharmaceuticals Pricing Policy
2.3 Foreign Direct Investment in Pharmaceuticals Sector
2.4 Cluster Development Programme for Pharma Sector (CDS-PS)
2.5 Scheme for Financing Common Facility Centers (CFCs) at Bulk Drug Park
2.6 Ease of Doing Business
2.7 International Cooperation/ Export Promotion of Pharmaceuticals
2.8 Pharmaceuticals Promotion Development Scheme (PPDS)
2.9 India Pharma 2017 and India Medical Device 2017
2.10 India Pharma Awards
3. AN OVERVIEW OF MEDICAL DEVICE INDUSTRY 21

3.1 Indian Medical Device Industry
3.2 Medical Device Market Size – Global
3.3 Medical Device Market Size- India
3.4 Medical Device Segments – India
3.5 Medical Device Rules, 2016
3.6 Initiatives for Promotion of Medical Device Industry
4. Pradhan Mantri Bhartiya Janaushadhi Pariyojana. 31
5. National Institutes of Pharmaceutical Education & Research (NIPERs) 39

5.1 Background
5.2 Admission Procedure
5.3 NIPER, Mohali
5.4 NIPER, Ahmedabad
5.5 NIPER, Guwahati
5.6 NIPER, Hajipur
5.7 NIPER, Hyderabad
5.8 NIPER, Kolkata
5.9 NIPER, Raibareli
6. PUBLIC SECTOR UNDERTAKINGS 63

6.1 Central Public Sector Undertakings
6.2 Cabinet Decision on Pharma PSU
6.3 Indian Drugs & Pharmaceuticals Ltd. (IDPL)
6.4 Hindustan Antibiotics Ltd. (HAL)
6.5 Karnataka Antibiotics & Pharmaceuticals Ltd. (KAPL)
6.6 Bengal Chemicals & Pharmaceuticals Ltd. (BCPL)
6.7 Rajasthan Drugs & Pharmaceuticals Ltd. (RDPL)
7. NATIONAL PHARMACEUTICAL PRICING AUTHORITY (NPPA) 85
8. IMPLEMENTATION OF RAJBHASHA 95
9. GENERAL ADMINISTRATION 99
9.1 Organizational Set Up
10. CITIZEN CENTRIC GOVERNANCE 103

10.1 Our Vision
10.2 Our Mission
10.3 Our Clients
10.4 Our Commitment
10.5 Our Services
10.6 Our Activities
10.7 RTI-2005
10.8 CPGRAMS
11. INFORMATION AND COMMUNICATION TECHNOLOGY 107
12. ANNEXURES 113

Annexure –I [A] (List of PSUs and Other Organizations)
[B] (Address and Name of various Organizations& PSUs
[C] (List of Responsibility Centers and Subordinate Organizations)
Annexure –II (Organizational Chart of NPPA)
Chapter 1
Introduction
CHAPTER – 1
CHAPTER 1.
INTRODUCTION
INTRODUCTION
The Cabinet Secretariat notified creation of a new Department, namely the
Department of Pharmaceuticals, under the Ministry of Chemicals & Fertilizers which
came into being w.e.f. 1st July 2008 with the objective to give greater focus and thrust
on the development of pharmaceutical sector in the country and to regulate various
complex issues related to pricing and availability of medicines at affordable prices,
research & development, protection of intellectual property rights and international
commitments related to pharmaceutical sector which required integration of work with
other ministries.
Following works have been allocated to the Department of Pharmaceuticals:
1. Drugs and Pharmaceuticals, excluding those specifically allotted to other
departments.
2. Medical Devices - Industry issues relating to promotion, production and
manufacture; excluding those specifically allotted to other Departments.
3. Promotion and co-ordination of basic, applied and other research in areas related
to the pharmaceutical sector.
4. Development of infrastructure, manpower and skills for the pharmaceutical sector
and management of related information.
5. Education and training including high end research and grant of fellowships in
India and abroad, exchange of information and technical guidance on all matters
relating to pharmaceutical sector.
6. Promotion of public – private – partnership in pharmaceutical related areas.
7. International co-operation in pharmaceutical research, including work related to
international conferences in related areas in India and abroad.
1
8. Inter-sectoral coordination including coordination between organizations and
institutes under the Central and State Governments in areas related to the
subjects entrusted to the Department.
9. Technical support for dealing with national hazards in pharmaceutical sector.
10. All matters relating to National Pharmaceutical Pricing Authority including related
functions of price control/monitoring.
11. All matters relating to National Institutes for Pharmacy Education and Research.
2
12. Planning, development and control of, and assistance to, all industries dealt with
by the Department.
13. Bengal Chemicals and Pharmaceuticals Limited.
14. Hindustan Antibiotics Limited.
15. Indian Drugs and Pharmaceuticals Limited.
16. Karnataka Antibiotics and Pharmaceuticals Limited.
17. Rajasthan Drugs and Pharmaceuticals Limited.
The work of the Department has been divided into three Divisions viz.
Pharmaceuticals Industry Division, Public Sector Undertakings Division and R& D
Division comprising of National Institute of Pharmaceutical Education & Research
(NIPER) and Research & Development. The National Pharmaceuticals Pricing
Authority, an attached office of this Department is entrusted with the work of fixation and
revision of prices of pharmaceuticals products under Drug Price Control Order 2013.
Shri Jai Priye Prakash is the Secretary, who holds the charge of this Department
w.e.f 01.07.2016.
3
Chapter
2
AN OVERVIEW OF PHARMACEUTICALS INDUSTRY
2.4 Cluster Development Programme for Pharma Sector (CDS-PS)
2.5 Scheme for Financing Common Facility Centers (CFCs) at Bulk Drug
Park
2.7 International Cooperation/ Export Promotion of Pharmaceuticals
2.8 Pharmaceuticals Promotion Development Scheme (PPDS)
CHAPTER
CHAPTER - 2 - 2
AN
AN OVERVIEW OFPHARMACEUTICALS
OVERVIEW OF THE THE PHARMACEUTICALS
INDUSTRY INDUSTRY
Financial Performance of the Drugs & pharmaceuticals industry. Pharma exports

record CAGR of 11.9% for decade ending 2015-16. Expect to complete projects worth
` 105.7 billion during 2016-19.
The Annual turnover of the Indian Pharma Industry during 2015-16 was 1,85,388
crores during 2015-16. It represented a decline of 7.4% over the correspondence figure
for 2014-15 i.e. 2,00,151 crores. The CAGR for last 5 financial years was 8.88%.
The domestic Pharma market witnessed a slowdown in the ongoing financial year
owing to the Government’s efforts to make medicines affordable. The impact of this can
be seen in the industry’s financials as well. The drugs & pharmaceuticals industry
reported poor sales performance for two consecutive quarters ended September 2016.
Sales grew by a mere 2.9 per cent in the September 2016 quarter, after a sluggish 2.5
per cent growth registered in the June 2016 quarter. The industry’s operating expenses
rose by 5.4 per cent during the September 2016 quarter, much faster than the growth in
sales. As a result, the industry’s operating profit declined by 5.4 per cent. Operating
margin contracted by 185 basis points to 21.1 per cent. A 3.4 per cent decline in the
industry’s post-operating expenses restricted the decline in its net profit to 0.8 per cent.
The industry’s net profit margin contracted by 160 basis points to 13.7 per cent during
the quarter.
The absolute figures available from the data provided by Centre for monitoring
Indian Economy Private Limited (CMIE) for the last 5 years is as per the following table.
Income & Expenditure Summary : Drugs & Pharmaceuticals Industry
Rs. Million: 2010-11 to 2015-16 5

S. Particular 2010-11 2011-12 2012-13 2013-14 2014-15 2015-16
No.
1. Total Income 14,09,099 15,10,061 16,48,757 19,18,723 20,01,508 18,53,879
2. Total 11,58,652 14,21,040 15,18,117 17,53,437 18,36,297 16,44,004
expenses
3. Profit before 4,39,716 3.18,476 3,38,153 4,39,199 4,56,616 4,50,514
tax
4. Profit after tax 2,77,945 1,17,337 1,52,141 1,89,291 1,90,994 2,17,781
Source Centre for monitoring Indian Economy Pvt. Ltd. (CMIE) data as on 15/02/2017
5
Performance of Pharma Exports: - During the decade ending 2015-16, India’s drug
exports grew at a CAGR of 11.9 per cent. This growth was backed by large number of
drugs going off patent, rise in the number of drug approvals and access to new markets.
According to the CMIE data, the trend in drug exports reversed in the ongoing financial
year. During April-November 2016, drug exports fell by one per cent. This is on account
of tightening of regulatory mechanism by various countries, price erosion in the US
market and economic crisis in the emerging markets. For the year 2016-17 as a whole,
drug exports are expected to dip by 0.4 per cent. The Quarterly financial indicators of
Indian Pharma Industry reflecting the figures of percentage change over previous
corresponding quarter are presented in the following table.
Income & Expenditure Summary: Drugs & Pharmaceuticals Industry

(Quarterly)
Y-o-Y % change: Mar 2016 to Dec 2016
S. No Particulars Mar-16 Jun-16 Sep-16 Dec-16
1. Total Income 4.57 3.37 3.77 5.1
2. Net sales 7.38 2.52 2.91 4.1
3. Total expenses 1.43 3.55 14.65 5.42
4. Operating expenses 3.17 3.64 5.15 4.8
5. Raw materials, stores & spares -8.91 -3.71 -1.66 -1.81
6. Salaries and wages 8.89 10.7 15.11 12.92
7. Power & fuel -13.16 12.38 11.7 18.52
8. Interest expenses 14.26 13.36 0.63 -1.25
9. Depreciation -11.41 13.5 9.75 9.73
10. PBT 12.95 -7.67 -4.79 8.02
11. Total tax provision 1.46 -10.13 -16.33 17.7
12. Net profit (PAT) 17.41 -6.82 -0.96 5.11
13. Total expenses net of P& E 42.96 -6.81 -0.99 2.35
14. PBDIT net of P& E 2.6 3.56 4.05 5.6
15. PBDIT net of P&E 16.28 -2.57 -2.03 5.66
16 PBDIT net of P&E & OI (Operating 18.47 -6.77 -5.45 2.93
Profit)
17. Count 151 151 149 128
Performance of Pharma Imports: - During April-November 2016, drug imports

6 declined by 9.3 per cent. This was on account of withdrawal of customs duty exemption
on a total of 71 drugs by the government. This move aimed at reducing the dependence
on drug imports and encourage local production. For the year 2016-17, drug imports are
likely to decline by 9.3 %.
Change in Principal Commodities by DGCIS for better access to Foreign Trade
data: It is important to point out that foreign trade data relevant for modern system of
medicines (relevant for the DoP) was not available. It was mainly on account of non-
availability of any clarity about the relevant HS Codes for Drug & Pharmaceuticals. The
basket of commodities considered for compilation of data on exports was different from
6
the one considered for compilation of data for imports. In order to alleviate this problem
after creation of separate Department of Pharmaceuticals, during 2008, the DoP
constituted an inter-Departmental Committee to list out the HS Codes relevant for Bulk
Drugs & Drug intermediates under chapter 29 and also list relevant HS Codes that are
not under the domain of DoP even in chapter 30 for Pharmaceutical formulations.
Based on the report of the above referred committee the DGCIS has since revised
Principal Commodity Groups and foreign trade data after March 2014 is now accessible
for following 4 main Principal Commodities:
1. Bulk Drugs & Drugs intermediates,
2. Drug formulation and Biologicals,
3. Surgicals and
4. AYUSH and Herbal Products.
Details about relevant HS Codes are now available on the websites of DGCIS and
DGFT.
The Future Prospects: - After completion of projects worth Rs.170.4 billion seen
during 2010-13, investments in the drugs and pharmaceuticals industry slowed down to
Rs.57.2 billion during 2013-16. We expect project completions to pick-up in the coming
years. Apart from formulations, the industry is investing to expand its capacity to
manufacture active pharmaceuticals ingredients (API) or bulk drugs manufacturing with
an aim to become self-sufficient with respect to API requirements. The industry
commissioned 11 projects during April-December 2016. Of these, cost details of eight
projects are available. These projects involve an investment outlay of Rs.11.6 billion.
Glaxosmithkline Pharmaceuticals, Shantha Biotechnics, Cipla Biotec and Aurobindo
Pharma are some of the companies which completed their projects during the period.
It is expected that projects worth Rs.17.5 billion to be completed by March 2017.
Going forward, projects worth Rs.45.1 billion are expected to be completed in 2017-18,
followed by projects worth Rs.31.5 billion to come up in 2018-19. 7
The Department of Pharmaceuticals had notified the National Pharmaceutical
Pricing Policy-2012(NPPP-2012) on 07.12.2012 with the objective to put in place a
regulatory framework for pricing of drugs to ensure availability of required medicines –
“essential medicines” – at reasonable prices, even while providing sufficient opportunity
for innovation and competition to support the growth of industry, thereby meeting the
goals of employment and shared economic well being for all.
7
Subsequently, to implement the NPPP-2012, the new Drugs (Prices Control)

Order, 2013 was notified on 15.05.2013 to control the prices of specified dosages and
strengths as under National List of Essential Medicines-2011(NLEM-2011). This was
modified to include medicines included in NLEM-2015 vide notification dated 10.03.2016
after the same was received from Ministry of Health & Family Welfare who had
constituted an Expert Core Committee to review and recommend the revision of
National List of Essential Medicines (NLEM-2011) in the context of contemporary
knowledge of use of therapeutic products.
Department of Industrial Policy & Promotion has reviewed the Foreign Direct
Investment (FDI) Policy and vide their Press Note No. 5 (2016 Series) dated 24/06/2016
has amended the FDI Policy whereby Pharmaceutical Companies for Greenfield
Pharma Projects can invest 100% FDI through automatic route and for Brownfield
Pharma Projects foreign investment upto 74% is allowed under automatic route and
beyond that the companies have to come through government route.
2.4 Cluster Development Programme for Pharma Sector (CDP-PS)
With a vision to catalyze and encourage quality, productivity and innovation in

pharmaceutical sector and to enable the Indian Pharmaceutical Industry especially
SMEs to play a leading role in a competitive global market, Hon’ble Minister of
Chemicals and Fertilizers approved the introduction of Cluster Development
Programme for Pharma Sector (CDP-PS) on 27.10.2014. The said report was
released by Hon’ble Minister of Chemicals and Fertilizers on 17.06.2015.
The CDP-PS is a Central Sector Scheme. The total size of the scheme is
proposed as Rs.125 Crores for CDP-PS for 12th Five Year Plan.
Assistance under the Scheme will be Rs. 20.00 Crore per cluster or 70% of
the cost of the project, whichever is less for creation of common facilities. Some of
the indicative activities under the Common facilities are:
x Common Testing Facilities
x Training Centre
8
x Effluent Treatment Plant

x R&D Centres
x Common Logistics Centre
3. Projects and Development India Limited (PDIL) who were chosen as the Project
Management Consulting (PMC) for implementing the scheme had called EOIs and after
processing the same, Scheme Selection Committee (SSC) has selected the proposal of
M/s Chennai Pharma Industrial Infrastructure Upgradation Company, Alathur., Chennai,
Tamilnadu. Further, the proposal of M/s Andhra Pradesh Industrial Infrastructure
Corporation (APIIC) Limited along with other proposals received is being examined by
PDIL.
2.5 Scheme for Financing Common Facility Centers (CFCs) at Bulk Drug Park
The vision of the Department of Pharmaceutical (DoP), Ministry of Chemicals &
Fertilizers is to catalyze and encourage quality, productivity and innovation in Bulk Drug
Sector and to enable the Indian Bulk Drug Industry to reduce the dependency on import
of Bulk Drugs. For this, world class quality manufacturing facilities with high level of
productivity with innovative capabilities are required. However, these are on one hand
very capital intensive and cannot be established and opened by Bulk Drug
Manufacturing Units on their own due to financial constraints.
In this direction, the Department proposes in the first instance to start a scheme
for Financing Common Facility Centres (CFCs) at 3 Bulk Drug/API Parks in the country
at a total cost of Rs. 450 crores. Some of the indicative activities under this Common
facilities are:
i. Effluent Treatment Plants
ii. Captive Power Plant
iii. Steam and Cooling and water systems
iv. Incubation facilities
v. Common logistic facilities
vi. Advance common testing centre
vii. Regulatory awareness facility centre 9
The objectives of this scheme are as under:-
(i) Increasing the competitiveness, easy access to standard testing and

infrastructure facilities and value addition in the domestic Bulk Drug Industry
through creation of common world class facilities.
(ii) Strengthening the existing infrastructure facilities in order to make Indian Bulk
Drug Industry a global leader in Bulk Drug Exports.
(iii) Reducing the cost of production by 20-25% in the Bulk Drug Park leading to
better availability and affordability of Bulk Drug in domestic market.
(iv) Exploiting the benefits arising due to optimization of resources and economies of
scale.
9
Department of Expenditure’s in-principle approval has been received for

implementing the scheme.

The Department of Pharmaceuticals has from time to time keeping with the need
has been amending the provisions of Drug (Prices Control) Order-2013 (DPCO-2013)
for doing ease of business. In this direction, on 22 March, 2016, the Department
amended Para-11 of DPCO-2013 so as to facilitate IV Fluid Manufacturers which would
also result in bringing in more foreign investment in the country and increasing
employment opportunities for the countrymen.
2.7 International Cooperation / Export Promotion of Pharmaceuticals
Joint Working Group (JWG)/High Technology Cooperation Group (HTCG)
Department of Pharmaceuticals has the following Joint Working Groups/High
Technology Cooperation Group:-
1. EU-India Joint Working Group on Pharmaceuticals, Biotechnology and Medical

Devices
2. India-Tunisia Joint Working Group on Drugs and Pharmaceuticals
3. India-Ukraine Joint Working Group on Pharmaceuticals and Healthcare
4. India-US High Technology Cooperation Group (HTCG)
5. India-Belarus Joint Working Group on Pharmaceuticals
6. India-Philippines Technical Working Group (TWG) for considering “Pharmazone”
and “Registration and other Issues related to Pharmaceuticals”
7. India-Algeria Joint Working Group (JWG) on Pharmaceuticals
8. India-Egypt Joint Study Group (JSG) on Pharmaceuticals and Health.
International Participations
10 1. 7th Meeting of EU-India was held on 5-6 July 2016 at Brussels under the Co-
chairmanship of Shri Sudhansh Pant, Joint Secretary, Department of
Pharmaceuticals.
2. A delegation led by Dr. M.A. Ahammed, the then Joint Secretary, Department of
Pharmaceuticals participated in 10th Annual Bio Pharma & Health Summit 2016
held on 02.06.2016 at Boston (USA)
3. 6th Meeting of India-Tunisia Joint Working Group on Drugs & Pharmaceuticals
was held on 11-13 January, 2017 at Tunis under the Co-chairmanship of Shri
Sudhansh Pant, Joint Secretary, Department of Pharmaceuticals
10
2.8 Pharmaceuticals Promotion Development Scheme (PPDS):

The Objective of Pharmaceuticals Promotion Development Scheme(PPDS) is
promotion, development and export promotion in Pharmaceutical sector by extending
financial support for conduct of seminars, conferences, exhibitions, mounting
delegations to and from India for promotion of exports as well as investments,
conducting studies/ consultancies, for facilitating growth, exports as well as critical
issues affecting Pharma sector. Under PPDS the Department of Pharmaceuticals on its
own or through financial support by way of Grant-in aid to the Institutions, organizations,
Voluntary organizations or Non-Government Organizations as mentioned in Rule 206 of
GFR 2005,
i) Conduct Training/knowledge improvement programs/activities on issues/subjects

relevant to growth of pharmaceutical industry. An indicative list of subject is as
under:-
a) Quality Management System/Quality Improvement Program
b) How to handle USFDA notice?
c) Success Story Presentation-Pharmaceutical Entrepreneur
d) Government regulations/guidelines for clinical trials in India versus USA,
EU etc.
e) Waste Management
ii) Organize Summits, Convention, Exhibitions, Pharmacy week, meetings etc. in
India and abroad and produce promotional materials like films, displays etc.
iii) Conduct research studies, sector reports etc.
iv) Purchase books, quality standards, pharmacopoeias, magazines, directories,
software for developing information data banks, developing e-learning modules
etc.
v) Give awards to achievers in pharmaceutical industry. 11
vi) For any other activity not covered under above categories which may be decided
by the Department of Pharmaceuticals from time to time.
Events organized/to be organized under Pharmaceuticals Promotion

Development Scheme (PPDS) during 2016-17 -
1 Conference on “APIs: Reducing dependence on Imports” on 28 July 2016 at

Baddi, Himachal Pradesh in association with the Associated Chambers of
Commerce & Industry of India (Assocham)
11
2 Seminar on “Bio-Pharma: Biosimilars & Biogeneric; Emerging Investment

Destination” on 6 October 2016 at Hyderabad in association with the Associated
Chambers of Commerce & Industry of India (Assocham)
3 Workshop (Indian Drug Manufacturers Association) on “Technology Upgradation
and Pharmaceutical Promotion” at National Institute of Pharmaceutical Education
and Research (NIPER), Kolkata on 29-30 July 2016 in association with NIPER,
Kolkata
4 National Conference on “Green Chemistry Challenges and Opportunities in India”
on 9 September 2016 at Durgapur in association with Durgapur Viswagandha
Science Society
5 World Congress on “Drug Discovery & Development-2016” on 23-25 November
2016 at Bangalore in association with Bio Genesis Health Cluster
6 National level Seminar “Global Perspective on Medical Devices” on 10 December
2016 at Rajkot in association with Saurahshtra University
7 National Symposium on (i) What do the fresher lacks for getting better jobs on
14-17 November 2016 and (ii) Job Fair for Student on 23-27 January 2017 at
Ahmedabad in association with National Institute of Pharmaceutical Education
and Research (NIPER), Ahmedabad
8 Seminar on “Meeting Quality and Achieving Global Compliance” on 29 July 2016
at Bangalore in association with Indian Drug Manufacturers' Association (IDMA)
9 Workshop on “Building Consumer Awareness on improving Accessibility to
Medicine” on 26/27 October 2016 in association with Consumer Online
Foundation
10 Seminar on “Meeting Quality and Achieving Global Compliance” on 26 August
2016 at Mumbai in association with Indian Drug Manufacturers' Association
(IDMA)
12 11 Seminar on “Meeting Quality and Achieving Global Compliance” on 10 October
2016 at Nashik in association with Indian Drug Manufacturers' Association
(IDMA)
12 National Seminar on Drug (Code for Marketing) Order UCPMP on 16 September
2016 at Bangalore in association with Karnataka Drugs & Pharmaceuticals
Manufacturers Association (KDPMA)
13 Seminar/Workshop on “Awareness on Jan Aushadhi Scheme” at Amritsar in
association with PHD Chamber of Commerce & Industry (PHDCCI)
12
14 Seminar/Workshop on “Awareness on Jan Aushadhi Scheme” at Bhopal on 30

September 2016 in association with PHD Chamber of Commerce & Industry
(PHDCCI)
15 Eight Awareness programmes on “Jan Aushadhi Scheme” in AP and Telangana
in association with National Institute of Pharmaceutical Education and Research
(NIPER), Hyderabad
16 National Conference on “Innovations in Novel Pharmaceutical
Technology/Processes alongwith a Workshop on GLP/GMP Compliance” on 24-
25 November 2016 at Hyderabad in association with National Institute of
Pharmaceutical Education and Research (NIPER), Hyderabad
17 National level Conference “Pharma Industry Meet on Cluster Development:
Strengthening Indian Pharma Industry” on 19 October 2016 at Hyderabad in
association with National Institute of Pharmaceutical Education and Research
(NIPER), Hyderabad
18 Seminar/Workshop on Awareness on Cluster Development Programme at
Dehradun on 23 February 2017 in association with PHD Chamber of Commerce
& Industry (PHDCCI)
19 Seminar/Workshop on Awareness on Cluster Development Programme on 16
March 2017 at Hyderabad in association with PHD Chamber of Commerce &
Industry (PHDCCI)
20 2nd Exhibitor on “Pharmaceuticals & Medical Equipment” on 8 February 2017 at
New Delhi in association with the Associated Chambers of Commerce & Industry
of India (Assocham)
21 Bio-Asia 2017 on 6-8 February 2017 at Hyderabad in association with Federation
of Asian Biotech Associations (FABA)
22 Conference on Drug Discovery and Development: Cancer and Lifestyle disease
on 16-17 February 2017 at Hyderabad in association with National Institute of 13
Pharmaceutical Education and Research (NIPER), Hyderabad
23 Seminar on “IPC 68th Indian Congress Pharma visio 2020: Seminar on Noval
Drug Delivery system at Vishakhapatnam in association with Indian
Pharmaceutical Association (MP Branch), Indore
24 Seminar on “Expectation of Regulators from Industries regarding WHO-GMP on
15 July 2016 at Indore in association with Indian Pharmaceutical Association (MP
Branch), Indore
13
25 Workshops on IPR for Pharma & Biotech Sector and Regulatory Perspectives at
Hyderabad, Ahmedabad and Mumbai in association with Pharmaceuticals Export
Promotion Council of India (Pharmexcil) at Ahmedabad, Mumbai and Hyderabad
26 National Conference: PharmaMEd 2016 in association with PHD Chamber of
Commerce & Industry (PHDCCI)
27 Seminar/Workshop on Awareness on Cluster Development Programme at
Ahmedabad on 29 January 2017 in association with PHD Chamber of Commerce
& Industry (PHDCCI)
28 Seminar on Price Regulation impact on Accessibility and Industry Perspectives in
association with PHD Chamber of Commerce & Industry (PHDCCI)
The Department of Pharmaceuticals provided financial assistances for the

following activities/events for promotion and development of Pharma sector from
Pharmaceuticals Promotion Development Scheme (PPDS) during Financial Year –
2016-17:-
S. No. Financial assistances

1 Financial assistance to Associated Chambers of Commerce & Industry of India
(Assocham) for organizing Conference on “APIs: Reducing dependence on Imports”
at Baddi, Himachal Pradesh

(Assocham) for organizing One day Seminar on “Bio-Pharma: Biosimilars &
Biogeneric; Emerging Investment Destination” at Hyderabad
3 Financial assistance to National Institute of Pharmaceutical Education and

Research (NIPER), Kolkata for organizing Workshop (Indian Drug Manufacturers
Association) on “Technology Upgradation and Pharmaceutical Promotion” at
NIPER, Kolkata on 29-30 July 2016
4 Financial assistance to Durgapur Viswagandha Science Society for organizing
National Conference on “Green Chemistry Challenges and Opportunities in India”
on 9 September 2016 at Durgapur
14 5 Financial assistance to Bio Genesis Health Cluster for organizing World Congress
on “Drug Discovery & Development-2016” on 23-25 November 2016 at Bengaluru
6 Financial assistance to Saurahshtra University for organizing One day National level
Seminar “Global Perspective on Medical Devices” on 10 December 2016 at Rajkot
Research (NIPER), Ahmedabad for organizing National Symposium on (i) What do
the fresher lacks for getting better jobs on 14-17 November 2016 and (ii) Job Fair
for Student on 23-27 January 2017 at Ahmedabad
8 Financial assistance to Indian Drug Manufacturers' Association (IDMA) for
organizing Seminar on “Meeting Quality and Achieving Global Compliance” to be
held on 29 July 2016 at Bengaluru
9 Financial assistance to Consumer Online Foundation for organizing Workshop on
“Building Consumer Awareness on improving Accessibility to Medicine” on 26/27
October 2016
14

organizing Seminar on “Meeting Quality and Achieving Global Compliance” on 26
August 2016 at Mumbai
organizing Seminar on “Meeting Quality and Achieving Global Compliance” on 10
October 2016 at Nashik
12 Financial assistance to Karnataka Drugs & Pharmaceuticals Manufacturers
Association (KDPMA) for organizing One day National Seminar on Drug (Code for
Marketing) Order UCPMP on 16 September 2016 at Bangalore
13 Financial assistance to Federation of Indian Chambers of Commerce & Industry
(FICCI) for Hosting Dinner during India Pharma 2016 and India Medical Device
2016
14 Financial assistance to PHD Chamber of Commerce & Industry (PHDCCI) for
organizing Seminar/Workshop on “Awareness on Jan Aushadhi Scheme” at
Amritsar on 16 September 2016
organizing Seminar/Workshop on “Awareness on Jan Aushadhi Scheme” at Bhopal
on 30 September 2016
Research (NIPER), Hyderabad for organizing 8 Awareness programme on “Jan
Aushadhi Scheme” from 15 August 2016 to November 2016 in AP and Telangana
Research (NIPER), Hyderabad for organizing National Conference on “Innovations
in Novel Pharmaceutical Technology/Processes alongwith a Workshop on
GLP/GMP Compliance” on 24-25 November 2016 at Hyderabad
Research (NIPER), Hyderabad for organizing National level Conference “Pharma
Industry Meet on Cluster Development: Strengthening Indian Pharma Industry” on
19 October 2016 at Hyderabad
organizing Seminar/Workshop on Awareness on Cluster Development Programme
at Dehradun on 23 February 2017
on 16 March 2017 at Hyderabad
(Assocham) for organizing 2nd Exhibitor on “Pharmaceuticals & Medical Equipment”
on 8 February 2017 at New Delhi
22 Financial assistance to Federation of Asian Biotech Associations (FABA) for
organizing Bio-Asia 2017 on 6-8 February 2017 at Hyderabad
Research (NIPER), Hyderabad for organizing Conference on Drug Discovery and
Development: Cancer and Lifestyle disease on 16-17 February 2017 at Hyderabad
15
24 Financial assistance to Federation of Indian Chambers of Commerce & Industry
(FICCI) for Dinner during India Pharma 2017 and India Medical Device 2017
25 Financial assistance to Indian Pharmaceutical Association (IPA), Indore for
organizing Seminar on “IPC 68th Indian Congress Pharma visio 2020: Seminar on
Noval Drug Delivery system at Vishakhapatnam
26 Financial assistance to Indian Pharmaceutical Association (IPA), Indore for
organizing Seminar on “Expectation of Regulators from Industries regarding WHO-
GMP on 15 July 2016 at Indore
27 Financial assistance to Pharmaceuticals Export Promotion Council of India
(Pharmexcil) for organizing Workshops on IPR for Pharma & Biotech Sector and
Regulatory Perspectives at Hyderabad, Ahmedabad and Mumbai on 26.09.2016,
03.10.2016 and 04.01.2017 respectively
15
28 Financial assistance to Directorate of Advertising and Visual Publicity (DAVP) for

organizing DAVP advertisements in connection with India Pharma 2017 and India
Medical Device 2017
organizing National Conference: PharmaMEd 2016 on 9 December 2016
at Ahmedabad on 29 January 2017
organizing Seminar on Price Regulation impact on Accessbility and Industry
Perspectives
32 Financial assistance to Green Chemistry for organizing Industrial Conference on 20-
21 February 2017

India Pharma 2017 and India Medical Device 2017, International Exhibitions &
Conferences on Pharmaceuticals and Medical Devices sector at Bangalore International
Exhibition Centre, Bengaluru, Karnataka was held on 11-13 February 2017. Both the
events consisted of International Exhibitions & Conferences along with a series of
concurrent events, such as CEOs’ Forum, Buyer-Seller Meet, International Drug
Regulators Meet etc. These events provided a platform to global investment community
to connect with stakeholders in the Pharma & Medical Devices sectors in India, Central
and State Governments, leading business leaders and top executives from the industry,
academics and experts from the world. These events had participation from Pharma
Formulation, Bulk Drugs, Machinery and Technology segment of the Pharmaceutical
and Medical Electronics Industry and Medical Electronic & Devices The CEO’s
Roundtables provided ample opportunities for discussing the major policies and trends
in the growth of the industry in the Indian Pharmaceutical & Medical Device Industry with
the Hon’ble Minister and top discussion makers in the Government.
16
16

Shri Ananth Kumar, Hon’ble Minister of Chemicals and Fertilizers and
Parliamentary Affairs gave away the 2nd India Pharma and Medical Devices Award
2017 at Bengaluru on 11th February, 2017. The list of awardees is given below:-
Sl. No. CAT No. Category of Award Name of the Company

i) 1 Overall India Pharma Excellence Award Lupin Limited
ii) 2 India Pharma Leader Award Shri Dilip Surana, CMD, Micro Labs
Limited
iii) 3 India Pharma Company of the Year Award Glenmark Pharmaceuticals Ltd.
iv) 4 India Pharma Bulk Drug Company of the Year Lupin Limited
Award
v) 7 India Pharma Innovation of the Year Award Dr. Reddy’s Laboratories Ltd.
vi) 8 India Pharma Research & Development Sun Pharmaceutical Industries
Achievement Award Limited
vii) 9 India Pharma Corporate Social Responsibility Lupin Limited
(CSR) Programme of the Year Award
viii) 10 India Medical Devices Company of the Year Meril Life Sciences Private Limited
Award
ix) 11 India Pharma Export Company of the Year Award Camus Pharma Pvt. Ltd.
x) 12 India Pharma Bulk Drugs Export Company of the Camus Pharma Pvt. Ltd.
Year Award
xi) 14 India Medical Devices Export Company of the Meril Life Sciences Private Limited
Year Award
xii) 15 India Pharma PSU of the Year Award Karnataka Antibiotics &
Pharmaceuticals Limited
17
17
Chapter
3
AN OVERVIEW OF MEDICAL DEVICE INDUSTRY
3.1 Indian Medical Device Industry
3.3 Medical Device Market Size- India
3.6 Initiatives for Promotion of Medical Device Industry
CHAPTER
CHAPTER 3.
–3
AN
AN OVERVIEW OF MEDICAL
OVERVIEW OF MEDICAL DEVICE INDUSTRY
DEVICE INDUSTRY
3.1 Indian Medical Device Industry:
Medical device industry is a multi-product industry, producing wide range of

products. India is growing as a key market for Medical Devices and Diagnostics. Indian
Medical Device industry depends on imports up to an extent of almost 70%. Most hi-
tech innovative products and technology originate from a well-developed eco-system
and innovation cycle which needs to be developed in India to promote indigenous
industry and to reduce our dependence on imports. Department of Pharmaceuticals has
a mandate to boost the medical device manufacturing sector in India.
In September 2014, the Indian Government launched the “Make in India”
campaign, with the objective of making India a global manufacturing hub; thus, bringing
foreign technology and capital into the country. Accordingly, a Task Force was formed
under the Chairmanship of Secretary, Department of Pharmaceuticals (DoP), to address
issues relating to the promotion of domestic production of high end medical device in the
country. The Task Force in its report released on 8th April 2015 had made a set of
recommendations for the promotion of medical device industry in the country.
x The global medical device market was estimated at USD 228 bn in 2015 (INR
14.82 lakh crores).
x Industry estimates suggest that the global medical device market will grow at a
CAGR of 7.8% from 2010 to 2020.
x The market is expected to reach USD 332 bn (INR 21.58 lakh crores) by 2020.
21
Figure: Global Medical Device Market Size

3.3. Medical Device Market Size- India
x The Indian medical device market has grown from USD 2.02 bn (INR 13,130
Crores) in 2009 to USD 3.9 bn (INR 25,259 Crores) in 2015 at CAGR of 15.8%.
19
This accounts for approximately 1.7% of the global medical device market in
2015.
x The Indian Medical Device market contributes to 4% of the Indian healthcare
market which is pegged at USD 96.7 bn (INR 6.29 Lakh Crores), in 2015.
x The industry estimate suggests that the Indian medical device market will grow to
USD 8.16 bn (INR 53,053 crore) in 2020 at CAGR of 16%.
x India is one of the top 20 global medical device markets and the 4th
largest medical device market in Asia.
Figure: Medical Device Market Size- India
x Diagnostic imaging is the largest segment within Indian medical device market in
2015. It constitutes USD 1.18 bn (INR 7,650 crores) in 2015 and will grow to USD
2.47 bn (INR 15,561 Crores) in 2020.
x Others and IV diagnostics comprise largely of electrical and electronic devices.
The others category (patient monitors, ECG machine, Defib, etc) is estimated at
22 USD 0.94 Bn (INR 5,922 Crores) in 2015 and will grow to USD 1.98 Bn (12,880
Crores) in 2020. Similarly, the IV diagnostics market constituted of USD 0.39 bn
(INR 2,550 crores) in 2015 and will reach USD 0.82 bn (INR 5,356 Crores) in
2020.
x Similarly, Orthopedics & Prosthetics and Consumables will grow from a
cumulative USD 0.90 bn (INR 5,850 crores) in 2015 to USD 1.88 bn (INR
12,220 crores) in 2020.
x Dental products and Patient Aids will grow from a cumulative USD 0.47 bn (INR
2,961 Crores) in 2015 to USD 1.1 bn (INR 6,930 Crores) in 2020
20
Figure: Growth Factors Driving the Medical Device Demand in India
The various factors driving the demand of medical device in India are as under:
(i) Growing Population
(ii) Ageing Population
(iii) Increasing Disease Burden of Chronic Diseases
(iv) Increasing Health Insurance Penetration
(v) Growing Medical Tourism
(vi) Demand for Healthcare Infrastructure
a. Emerging Healthcare Service Formats
b. Quality and Accreditation of Hospitals as par with International
Standards.
23
21

The mandate for regulation of Medical Device Industry from safety and standards
point of view is with Ministry of Health & Family Welfare, which has notified Medical
Devices Rules, 2017 on 31.01.2017. The new Rules have been framed in conformity
with Global Harmonisation Task Force (GHTF) framework and conform to best
international practices. The new Rules seek to remove regulatory bottlenecks to make in
India, facilitate ease of doing business while ensuring availability of better medical
devices for patient care and safety. The salient features of these Rules are:
i. Medical devices will, under the new Rules, be classified as per GHTF practice,
based on associated risks, into Class A (low risk), Class B (low moderate risk),
Class C (moderate high risk) and Class D (high risk). The manufacturers of
medical devices will be required to meet risk proportionate regulatory
requirements that have been specified in the Rules and are based on best
international practices.
ii. Through these Rules, a system of ‘Third Party Conformity Assessment and
Certification’ through Notified Bodies is envisaged. The Notified Bodies will be
accredited by the National Accreditation Board for Certification Bodies (NABCB).
The NABCB will, before accrediting Notified Bodies, assess their competence in
terms of required human resources and other requirements.
iii. The Rules also seek to evolve a culture of self-compliance by manufacturers of
medical devices and, accordingly, the manufacturing licences for Class A medical
devices will be granted without prior audit of manufacturing site. Manufacture of
Class A and Class B medical devices will be licenced by State Licensing
Authorities concerned after Quality Management System audit by an accredited
Notified Body. For all manufacturing sites, Quality Management System will need
24 to be aligned with ISO 13485. Manufacture of Class C and Class D medical
devices will be regulated by the Central Licensing Authority and, where required,
assistance of experts or notified bodies will be taken. Import of all medical
devices will continue to be regulated by CDSCO.
iv. Separate provisions for regulation of Clinical Investigation (clinical trials) of
investigational medical devices (i.e. new devices) have also been made at par
with international practices and, like clinical trials, these will be regulated by
CDSCO.
22
v. There will be no requirement of periodic renewal of licences. Accordingly,

manufacturing and import licences will remain valid till these are suspended or
cancelled or surrendered. Further, the entire process starting from submission of
application to grant of permission/licence will be processed through online
electronic platform. Timelines have been defined for most activities at the
regulators end.
vi. These Rules envisage creation of a robust eco-system for all stakeholders
including innovators, manufacturers, providers, consumers, buyers and
regulators.
vii. The Rules will provide a conducive environment for fostering India specific
innovation and improving accessibility and affordability of medical devices across
the globe by leveraging comparative cost advantage of manufacturing in India.
The objective, transparent and predictable regulatory framework will boost the
confidence of investors and, as a consequence, the quality and range of products
and services will improve and business burdens will be reduced.
3.6 Initiatives for Promotion of Medical Device Industry:
The vision of the Department of Pharmaceutical (DoP), Ministry of Chemicals &
Fertilizers is to catalyze and encourage quality, productivity and innovation in Medical
Device Sector and to enable the Indian Medical Device Industry to reduce the
dependency on import of Medical Devices. For this, world class quality manufacturing
facilities with high level of productivity with innovative capabilities are required. However,
these are very capital intensive and cannot be established and opened by Medical
Device Manufacturing Units on their own due to financial constraints.
3.6.1 Scheme for Financing Common Facility Centres (CFCs) at Medical Device Parks:
The Department has a proposal for scheme for “Development of Common
Facilitation Centres for Medical Devices” in medical device parks under the Umbrella
scheme for “Development of Pharmaceuticals Industry”. This sub-scheme proposes for 25
Financing Common Facility Centres (CFCs) at Medical Device Parks in the country at a
total cost of Rs.250 crores. The manufacturing parks would include following facilities:
i. Component Testing centre,
ii. Electro-magnetic interference laboratory,
iii. Biomaterial/Biocompatibility testing centre,
iv. Medical grade low vacuum molding,
v. Cabinet molding, injection molding centres,
vi. 3 D designing and printing for medical grade products,
vii. Sterilization & Toxicity testing centre,
viii. Radiation testing centre,
ix. Warehousing,
23
x. Regulator’s office,
xi. Other facilities commonly required in manufacturing of medical devices
Focus will be on creating an Eco System for High End Medical Device
Manufacturing and Import Substitution with an eye for Export Market and states have
selected separate verticals within medical devices segment suiting their regional
capacities, availability of natural resources and expertise.
3.6.2. Corrections in the Inverted Duty Structure:

a. The customs department has raised import duty on 67 ITC Categories of Medical
Devices from the current 5 per cent to 7.5 per cent to help companies manufacture
these products in India itself.
b. Simultaneously, the exemption from special additional duty (SAD) on these
medical devices has also been withdrawn, and they now attract 4 per cent SAD.
c. Further, to give fillip to domestic manufacturing, basic customs duty is being
reduced from 7.5 per cent to 2.5 per cent along with full exemption from SAD on raw
materials, parts and accessories for manufacture of medical devices falling under
headings 9018 to 902230.
These changes will aid in removing the existing hurdles in domestic
manufacturing of medical devices and encourage companies to produce these devices
in India, rather than importing them.
3.6.3. Medical Device Promotion Council:

The Department is also considering a proposal for establishment of a Medical
Device Promotion Council in co-operation with Andhra Pradesh MedTech Zone Ltd.
(AMTZ) at Vishakhapatnam which will act as a facilitating and promotional body for
domestic Medical Device Industry.
3.6.4. Preferential Market Access:

26 To promote domestic manufacturing of medical devices and to reduce the import
dependency, the Department is considering a proposal for giving preference to domestic
industry in purchase of medical devices by all government agencies.
3.6.5. Uniform Code For Medical Device Marketing Practices (UCMDMP):

Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) for
pharmaceutical as well as Medical Device Industry was announced to be implemented
voluntarily for a period of six months w.e.f. 1.1.2015. This has further been extended up
to 31.12.2015. In the meantime, the need for a separate code for Medical Device
24
Industry was felt and a draft Uniform Code for Medical Device Marketing Practices
(UCMDMP) was prepared. Further, it was decided to consult UCMDMP with the
stakeholders. Two meetings in this regard were held with the stakeholders for
incorporating their suggestions and further course of action in the matter.
[Source: Para 1.1, 1.2, 1.3 & 2 (Medical Device Manufacturing in India: A Sunrise
report by AMTZ)]
27
25
Chapter
4
Pradhan Mantri Bhartiya Janaushadhi Pariyojana.
CHAPTER
CHAPTER -4 4
Pradhan Mantri Bhartiya Janaushadhi Pariyojana.
4.1 Pradhan Mantri Bhartiya Janaushadhi Pariyojana
Introduction:
The Jan Aushadhi Scheme was launched in the year 2008 with the aim of selling
affordable generic medicines through dedicated sales outlets i.e. Jan Aushadhi Stores in
various districts across the country. Some of the objectives of the scheme are as
follows:-
x Ensure access to quality medicines
x Extend coverage of quality generic medicines so as to reduce and thereby
redefine the unit cost of treatment per person
x Create awareness about generic medicines through education and publicity so
that quality is not synonymous with only high price
x Be a public programme involving Government, PSUs, Private Sector, NGO,
Societies, Co-operative Bodies and other Institutions
x Create demand for generic medicines by improving access to batter healthcare
through low treatment cost and easy availability wherever needed in all
therapeutic categories.
The first Jan Aushadhi Store was opened at Amritsar in Punjab in November 2008.
The original target of the campaign was to establish Jan Aushadhi Stores in
every district of our country. Recently, “Pradhan Mantri Jan Aushadhi Yojana” (PMJAY)
has been renamed as “Pradhan Mantri Bhartiya Janaushadhi Pariyojana” (PMBJP) and
“Pradhan Mantri Jan Aushadhi Kendra” (PMJAK) as “Pradhan Mantri Bhartiya
Janaushadhi Kendra” (PMBJK).
Bureau of Pharma PSUs of India (BPPI):
BPPI is an independent society set up by the Department of Pharmaceuticals,
Ministry of Chemicals & Fertilizers in December, 2008. BPPI’s mission “Is to make
31
generic medicines available for all”. BPPI is responsible for proper monitoring and
functioning of Pradhan Mantri Bhartiya Janaushadhi Kendras.
Progress during 12th Five-year Plan period:
As on end March 2012, only 112 Pradhan Mantri Bhartiya Janaushadhi Kendra
(PMBJK) could be opened. To have an accelerated growth of the campaign, a New
Business Plan was released during August 2013 with an ambitious target of opening
3000 PMBJK by the end of 2016-17. The plan also contained certain changes in the
27
scheme. Still by the end of previous financial year 2015-16, the number of PMBJK could
reach a level of 269 functional PMBJK only.
Revamped Jan Aushadhi Scheme 2015:
Effective implementation of Pradhan Mantri Bhartiya Janaushadhi Pariyojana
(PMBJP) has been analyzed through organizing brain storming sessions and
discussions with various stake holders and BPPI submitted their Strategic Action Plan
(SAP 2015) to achieve the objectives set by the Government. Key areas of significance
identified are Availability, Acceptability, Accessibility, Affordability, Awareness and
Effective Implementation of the Scheme. Accordingly, a new Strategic Action Plan was
prepared and the same was approved during September, 2015.
Major changes in Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)
Action Plan:
BPPI have simplified the application format so that a common man can easily fill
up the same. Besides above, the application fee of Rs. 2000/- which was charged
earlier have been waived of to make the scheme popular.
Financial support to Pradhan Mantri Bhartiya Janaushadhi Kendra (PMBJK):
An amount of Rs. 2.5 lakhs shall be extended to NGOs/agencies/individuals
establishing PMBJK in government premises like hospitals/ medical
colleges/Railways/Sate Transport/ Co-operation/ Municipalities/ Post offices etc. where
space is provided free of cost by Government to operating agency:
Rs. 1 lakh reimbursement of furniture and fixtures
Rs. 1 lakh by way of free medicines in the beginning
Rs. 0.50 lakh as reimbursement for computer, internet, printer, scanner, etc.
PMBJK run by private entrepreneurs/pharmacists/NGOs/charitable organizations
that are linked with BPPI headquarters through internet shall be extended an incentive
up to Rs. 2.5 lakhs. This will be given @ 15% of monthly sales subject to a ceiling of Rs.
32 10,000/- per month up to a limit of Rs. 2.5 lakhs. In North Eastern States i.e. Naxal
affected areas and Tribal areas, the rate of incentive will be 15% and subject to monthly
ceiling of Rs. 15,000 and total limit of Rs. 2.5 lakhs. The Applicant belonging to weaker
section like SC/ST/Differently-abled may be provided medicines worth Rs. 50,000/- in
advance within the incentive of Rs. 2.5 lakhs which will be provided in the form of 15%
of monthly sales subject to a ceiling of Rs. 10,000/- per month up to a total limit of Rs.
2.5 lakh.
Trade margin to retailers and distributors: Trade margins have been revised from
16% to 20% for Retailers and from 8% to 10% for Distributors.
28
Progress achieved during 2016-17 as on 16th February, 2016:

Availability:
Our basket of products and services is now augmented by adding more
medicines reaching a level of 600+ medicines and 165 surgicals and consumables.
Apart from procurement of medicines from CPSUs, BPPI is supplementing supply by
direct purchase of medicines from private sector companies through open tendering
process so as ensure availability of adequate medicines and to avoid any stock-out
situation. BPPI has initiated the required action to take this figure to 1000 by the end of
March 2017.
Supply Chain:
From Suppliers ĺCWH ĺC&F Agents ĺDistributors ĺ JAK
BPPI has established a central warehouse at IDPL Complex, Gurugram to store
adequate stock of medicines and also appointed C&F agents in 3 States and 40
Distributors spread over different states through an open tendering process. BPPI is
going to appoint more C&F agents and distributors shortly considering the requirement
to cover all the States/UTs.
Acceptability:
To ensure the quality of medicines procured from the CPSUs and private
manufacturers for supplying to PMBJK, each batch of drugs is tested at BPPI’s
empaneled NABL accredited laboratories thereby ensuring quality, safety and efficacy of
medicines and conformance with required standards. Only after being certified by these
laboratories, medicines are dispatched to C&F agents, Distributors and PMBJKs.
Accessibility:
Number of PMBJK functioning as on 16.02.2017 has reached 794 (spread over
26 States/UTs), out of which 525 stores have been opened during the current financial
year 2016-17.
By the end of this financial year, BPPI is putting all out efforts to have its 33
presence in all the States in our country. BPPI strive to achieve the figure of 3000
PMBJK by the end of March 2017.
Awareness:
The awareness among common people regarding the PMBJK is poor. Media
campaigns would play an important role in educating people about use of generic
medicines. In this context, BPPI has initiated various steps, especially in those States
where the PMBJK are now functioning so that people take full advantage of the
29
availability of generic medicines at affordable prices at the PMBJK. There are 794
PMBJK functional at present (as on 16.02.2017), few of which were established earlier.
These PMBJKs need to be promoted in an organized way as the awareness is very
less. Limited and non-availability of the medicines was another challenge. It is most
important to create awareness among all stakeholders about the scheme, the business
opportunity, the store locations and the medicines available with PMBJK.
BPPI intends to create awareness about PMBJP and its PMBJK in the towns
where PMBJKs are already established using integrated media platform. Facelift of the
PMBJK is required with standardized branding across all old stores as well as in the
new PMBJK.
Various publicity channels like print media, visual media, SMS and other direct
communication methods will be taken up. BPPI has already taken part in many
exhibitions/workshops, seminars, etc.
BPPI participated in India Pharma, 2017 at Bangalore to contact many large
scale manufacturers for PMJAY under one roof.
MoUs signed with Different State Governments for opening PMBJK:
34
30
Inauguration of Various PMBJK:
35
31
Youth education about PMBJP:
Other factors in ensuring success of the scheme:
The success of this initiative is dependent on other agencies too, such as Ministry
of Health & Family Welfare, different State Governments, active co-operation of Hon.
Members of Parliament, Hon. Members of different Legislative Assemblies, IMA,
Hospitals run by Private Groups and Charitable Institutions, NGOs, Practicing Doctors,
etc. State Governments are having their own schemes like free distribution of
medicines. Non-prescription of Generic Medicines by the doctors is another critical
factor. BPPI is continuing its efforts to persuade Doctors to prescribe only generic
medicines. For this BPPI is working in close association with other Organizations and
Government Departments. Seminars/Workshops inviting Doctors, Scientists,
Government Officials and other Stakeholders will be also organized.
Budgeted Sales:
In the financial year 2015-16, BPPI has done Rs. 11.25 Crores sale and in the
current financial year 2016-17, the projected sales shall be more than Rs. 20.00 Crores.
Jan Aushadhi scheme ahead:
The endeavor of BPPI is to make available at PMBJK all the commonly used
generic drugs covering all the therapeutic groups. In the coming years, PMBJP shall
36 provide the complete spectrum of Health care products and services, starting from
making available all the generic drugs covering all the therapeutic groups.
In order to attract the citizen to get engaged with the PMBJP, paper
advertisements were released inviting them to open PMBJK. In order to attract ST/SC
and specially disabled citizens, the Government support scheme has been modified to
give medicines worth Rs. 50,000/- in advance within the support of Rs. 2.50 lakhs to
start the store.
32
Chapter
5
National Institutes of Pharmaceutical Education & Research
(NIPERs)
5.1 Background
5.2 Admission Procedure
5.3 NIPER, Mohali
5.4 NIPER, Ahmedabad
5.5 NIPER, Guwahati
5.6 NIPER, Hajipur
5.7 NIPER, Hyderabad
5.8 NIPER, Kolkata
5.9 NIPER, Raibareli
CHAPTER - 5
National
CHAPTER 5
Institutes of Pharmaceutical Education &
Research (NIPERs)
National Institutes of Pharmaceutical Education & Research (NIPERs)
5.1 Background
Indian Pharma Industry has been a global leader in Generic drugs. In order to
acquire leadership position in drug discovery and development and to continue to excel
in the formulations, Government has recognized that human resources/talent pool is
very critical. A National Institute of Pharmaceutical Education & Research (NIPER) was
set up at Mohali, Punjab as a registered society under the Societies Registration Act,
1860, Subsequently, the Institute was given statutory recognition by an act of
Parliament, NIPER Act, 1998 and it was declared as an Institute of National Importance.
During 2007-08, six new NIPERs were started at Ahmedabad, Guwahati, Hajipur,
Hyderabad, Kolkata and Raebareli with the help of Mentor Institutes. Subsequently,
NIPER at Madurai was approved in 2012. During 2015-16, the Finance Minister in his
Budget Speech announced 3 new NIPERs for the states of Chhattisgarh, Maharashtra
and Rajasthan. The details are as under:
NIPER Mentor Institute Academic Session
Started
Mohali - 1992
Ahmedabad - 2007
Guwahati Guwahati Medical College, Guwahati 2008
Hajipur Rajendra Memorial Research Institute of 2007
Medical Science (RMRIMS-Patna) under
ICMR
Hyderabad CSIR-Indian Institute of Chemical Technology, 2007
Hyderabad
Kolkata CSIR-Indian Institute of Chemical Biology, 2007
Kolkata
Raebareli CSIR-Central Drug Research Institute, 2008
Lucknow
Madurai Under Process -
Chhattisgarh Under Process -
39
Maharashtra Under Process -
Rajasthan Under Process -
Objectives of NIPERs:
1. to nurture and promote quality and excellence in pharmaceutical education

and research;
2. to concentrate on courses leading to master's degree, doctoral and post-
doctoral courses and research in pharmaceutical education;
3. to hold examinations and grant degrees;
34
4. to confer honorary awards or other distinctions;

5. to cooperate with educational or other institutions having objectives wholly
or partly similar to those of the Institute by exchange of faculty members
and scholars and generally in such manner as may be conductive to their
common objective;
6. to conduct courses for teachers, pharmaceutical technologies, community
and hospital pharmacists and other professionals;
7. to collect and maintain world literature on pharmaceutical and related
sciences and technology so as to develop an information centre of its own
kind for other institutions within the country and in the developing world;
8. to create a central faculty of pharmaceutical instrumentation and analysis for
use by the researches within and outside the Institute;
9. to have a centre to experiment and innovate and to train teachers and
other workers in the art or science or pharmaceutical teaching;
10. to develop a world level centre for creation of new knowledge and
transmission of existing information in pharmaceutical areas with focus
on national, educational professional and industrial commitments;
11. to develop a multi-disciplinary approach in carrying out research and training of
pharmaceutical manpower so that the larger interests of the profession
academia and pharmaceutical industry are better served and a
pharmaceutical work culture is evolved which is in tune with the changing
world trends and patterns of pharmaceutical education and research;
12. to organise national or international symposia, seminars and conferences
in selected areas of pharmaceutical education, from time to time;
13. to arrange courses catering to the special needs of the developing
countries;
40 14. to act as nucleus for interaction between academic and industry by
encouraging exchange of scientist and other technical staff between the
Institute and the industry and by undertaking sponsored and funded
research as well as consultancy projects by the Institute; and
15. To pay due attention to studies on the distribution and usage of drugs by
the rural masses, taking into account the socio-economic spectrum in the
country.
35
5.2 Admission Procedure:
The students at all NIPERs are admitted through Joint Entrance Examination. The
admission procedure followed for various courses offered by each NIPER in the
country is as follows:
In the month of April every year advertisement is floated for Masters and PhD
programme. Accordingly, applications are invited on the basis of eligibility.
Masters'- B Pharm + GPAT qualified
PhD-MS (Pharm)/M Pharm/M Tech (Pharm)/M Sc. + GATE/GPAT/NET
qualified Applications are sorted on the basis of eligibility.
Eligible candidates appear for Joint Entrance Exam Scheduled on second
Sunday of June every year.
Result of passed candidates floated on net.
Basis of final selection:
Written + Counseling is held for Masters candidates.
Written + GD/Interview/Counseling is held for MBA
Written + Interview + Counseling is held for PhD candidates.
Reservation policy of Govt. of India is fully followed in admitting the students to

various courses.
Academia Industry Linkage:
Department has identified that Academia-Industry linkage is a basic requirement
for translating research into development (commercialization) and Innovation; and also
to fix accountability among Educational Institutions. Accordingly, the issue has been
pursued with NIPERs and Public and Private Pharma Industry with regular reviews and
visits. NIPERs have signed MoUs with Private Pharma Industry and CPSE as under:
NIPER Private Pharma Industry

Hyderabad 1. Dr. Reddy Labs
2. Bharat Biotech
3. NATCO
Ahmedabad 4. Cadila Pharmaceuticals
5. Cadila Healthcare (Zydus) 41
6. Sahjanand Technologies
7. Johnson & Johnson
Mohali 8. Sun Pharma
9. Wockahardt
10. Panacea Biotech
11. Medley Pharmaceuticals Ltd.
12. Dow Chemical International Pvt. Ltd.
13. Tirupati Medicare Ltd.
14. Kwality Pharmaceuticals Ltd.
15. Celeste Life Sciences Pvt. Ltd.
36
With Central Public Sector Enterprises
NIPER CPSEs
Mohali 16. Rajasthan Drugs and Pharmaceuticals Ltd., Jaipur.
Ahmedabad 17. Hindustan Anti-biotics Limited, Pune.
Guwahati 18. i) NATCO Pharma
ii)Karnataka Antibiotics & Pharmaceuticals Limited, Bengaluru.
Hajipur 19. Bengal Chemicals and Pharmaceuticals Limited, Kolkata
Kolkata 20. Bengal Chemicals and Pharmaceuticals Limited, Kolkata
Rae Bareli 21. Indian Drugs & Pharmaceuticals Limited Rishikesh/Gurgaon/
Hyderabad.
5.3 NIPER, MOHALI

NIPER Mohali has been declared as an “Institute of National Importance” through
an Act of Parliament. The Institute has been conceptualized, planned and set up to
provide leadership in pharmaceutical sciences and related areas not only within the
country, but also to the countries in South East Asia, South Asia and Africa. It is only
one of its kind in its domain and is highly valued for its outcomes – namely well trained
and focused human resources (students / researchers); publications of high impact and
novel processes / outputs of industrial relevance in its chosen areas of working. NIPER
Mohali has a campus that caters for research facilities for ten different fields, three boys
hostels and a girls hostel, one married hostel unit, 133 quarters for the NIPER staff.
NIPER Mohali comes from different parts of the country. In year 2016 students
belongs to approx. 22 different states and 2 UT. Most of the students belongs to Middle
and low income group. NIPER, Mohali has an own residential campus. Board of
Governors has been constituted to oversee its functioning.
1. Achievements:
In 2016, the Institute has published 51 articles in journals of repute (till Sept. 2016).
NIPER has filed 12 patents in 2015 and 1 patent has been granted till date this year.
42 Since the inception of academic programme (till Sept. 2016), 2692 students have
passed out (Masters 1960, MBA 487 & Ph.D. 245).
2. Research:
A. Neglected diseases - Research is carried out in the areas of tuberculosis,
leishmaniasis and malaria. New molecules are being synthesized and their mechanisms
of action are being worked out.
B. Other diseases
Metabolic pathways in diseases like inflammation, infection, cancer, diabetes,
neuro degeneration are being worked out.
37
C. Drug development and formulation
i. Improvement of oral bioavailability, synergistic anticancer efficacy and reduced
Metabolic pathways in diseases like inflammation, infection, cancer, diabetes,
neuro degeneration are being worked out.
C. Drug development and formulation
i. Improvement of oral bioavailability, synergistic anticancer efficacy and reduced
toxicity of drugs has been attempted.
ii. New formulations are being developed.
D. Other areas
i. Chemo-enzymatic synthesis of drugs
ii. Monograph on herbals is being developed.
iii. Study of the effect of RNA aptamers on stabilization of misfolded proteins
iv. Assessment of an appropriate and reliable method to diagnose neuropathic
pain
3. Academic and Non-Academic staff:-
Man-Power Sanctioned In Position Vacancies

Academic 61+1* = 62 30 31+1* = 32
Non-Academic 217+6**=223 127 90+6**=96
*indicates post of Director **indicates posts created by BoG
4. Total funds allocated during the last 4 years:
(Rs. in crores)
Year Allocation BE Allocation RE Total
Release
2012-13 Plan 24.00 0.00 0.00
Non-Plan 27.55 22.82 22.82
2013-14 Plan 12.00 0.00 0.00
Non-Plan 23.57 19.20 19.20
2014-15 Plan 20.00 17.03 0.00
Non-Plan 00.05 20.87 20.87
2015-16 Plan 20.00 9.79 9.79

Non-Plan 27.48 27.48 27.48
2016-17 Plan 00.01 0.00 0.00

Non-Plan 27.48 27.48 27.48
5. Students: 43
Degrees/ programmes offered and Subjects offered (with year) with admission
status
Level Degree Discipline No. of students admitted
Masters/ MS/MBA/
Doctorate M.Tech/Ph.D
2015-16 2016-17
Masters’ M.S.(Pharm.) Medicinal Chemistry 43 43
Doctoral PhD 02 05
Masters’ M.S.(Pharm.) 38 19 19
Pharmacoinformatics
Doctoral PhD 01 01
Masters’ M.S.(Pharm.) 16 16
Natural Products
Doctoral PhD 03 01
Masters’ M.S.(Pharm.) Traditional Medicine 05 05
Doctoral PhD Annual
02 Report
05| 2016-17
Pharmacoinformatics
Doctoral PhD 01 01
Natural Products
Doctoral PhD 03 01
Masters’ M.S.(Pharm.) Traditional Medicine 05 05
Pharmaceutical Analysis
Doctoral PhD 02 00
Pharmacology & Toxicology
Doctoral PhD 04 06
Masters’ M.S.(Pharm.) Regulatory Toxicology 09 10
Masters’ M.Tech.(Pharm.) Pharmaceutical Technology 07 07
Doctoral PhD (Formulations) 00 00
Doctoral PhD (Process Chemistry) 00 00
Doctoral PhD (Biotechnology) 00 00
Pharmaceutics
Doctoral PhD 06 06
Biotechnology
Doctoral PhD 05 02
Masters’ M.Pharm. 08 07
Pharmacy Practice
Doctoral PhD 02 01
Masters’ M.Pharm. Clinical Research 07 08
Masters’ MBA (Pharm.) Pharmaceutical Management 45 38
6. Teacher-Student ratio:-
Course Ratio
Ph.D. 1:3
Masters’ (Science) 1:14
MBA (Pharm.) 1:27*
* Guest faculty members are also taking classes
7. Placement:
The status of last 2 years placements status: in campus/off campus is as under:
Total Number of Campus Went for Higher Off Campus
Batch
Students Placed Placement Studies Placement
2013-15 143 92 11 40
2014-16 142 142 N.A. N.A.
N.A. Data not available
8. Innovation / knowledge transfer:
44 i. Patents and Commercialisation: 179 (filed)/38 (granted)/07 (licensed)
ii. Research income earned from industry: Rs.1.65 crores (receipts in 2016-17 till
date)
iii. Citation per faculty: 798 (2016 till date)
9. Institution leadership
i. Recognized as among the top 100 Indian Innovator companies and
research organizations (2014) (Thompson Reuters)
ii. Recognized as one of the four institutes in the country with AAAA+ ranking
39
by Career360 magazine (Outlook group) (March 2014)
iii. Awarded Thomson Reuters Innovation Award 2011
iv. Astra Zeneca endowment fund set up (Rs. 60 lakh)
v. Bristol-Myer-Squibbs has funded one student each for PhD and Masters’
ii. Recognized as one of the four institutes in the country with AAAA+ ranking
by Career360 magazine (Outlook group) (March 2014)
iii. Awarded Thomson Reuters Innovation Award 2011
iv. Astra Zeneca endowment fund set up (Rs. 60 lakh)
v. Bristol-Myer-Squibbs has funded one student each for PhD and Masters’
programme since 2008
vi. Eli Lilly and Merck have granted funds for carrying out research work
vii. Chosen as one of the destinations (apart from USA and UK) by
Government of Kazakhstan for award of Bolashak scholarship to its
nationals to pursue research programme in pharmaceutical sciences
viii. Received state and national awards for efforts to promote Rajbhasha
10. Impact of NIPER
The success of NIPER, Mohali has encouraged the GoI to set up more NIPERs
across the country to meet the growing demands of the pharmaceutical sector. In
addition, NIPER has carried out training programmes for personnel from India and
abroad under ITEC-SCAAAP, capacity building programmes (World Bank-sponsored)
and SMPIC. Participated in re-building of public sector enterprises like IDPL, BCPL,
HAL, etc.
Training and analytical services provided to small and medium-scale enterprises
(SMEs): Setting up of a centre for SMEs Member of committee evaluating
‘Investigational New Drugs’ (IND) applications Member of committee revising Indian
pharmacopeia Contribution of monographs to Ayurvedic pharmacopeia of India Carried
out study on “Impact of TRIPS on pharmaceutical prices with special focus on generics
in India”, under the work plan of WHO biennium and MHFW (GOI)
Events/ workshops carried out by the institute:-
February 14-16, 2016 Industry Academia Meet
February 22-24, 2016 International Symposium on Integrated Drug

Development: Chemistry, Manufacturing and Control
(CMC)
March 28, 2016 Seminar on ‘Applications of Dissolution Techniques in 45
Pharmaceutical Formulations’ (SMPIC)
40
5.4 NIPER Ahmedabad
NIPER Ahmedabad started functioning in 2007-08 under Mentor Institute B.V. Patel
PERD Centre (up to 31 July 2016). Since then it is functioning at its own campus in
temporary building. In absence of Board of Governors, Steering Committee under the
Chairmanship of Secretary (Pharma) looks after administrative work of NIPER
Ahmedabad. Dr. Kiran Kalia is its Director from 16.11.2014.
1. Achievements:
316 M.S Pharm. students have graduated from NIPER Ahmedabad and well
placed in various Pharma industries in India and abroad. NIPER Ahmedabad has
started Chapter with Foreign Universities like John Hopkins and Harvard University
USA. More than 70 papers have been published in various reputed Journals. 10
Patents have been filed where faculty or student of NIPER Ahmedabad was one of the
inventors. Out of this 3 patents have been filed from Feb 2016 till date.
2. Details of faculty & staff :
i. Regular Faculty: 01 (Director)
ii. Contractual Faculty: 14
iii. Contractual Admin and technical staff: 10
3. Total Allocation by the Government during the last 4 years.

(Rs. in crores)
Year Allocation BE Allocation RE Total Release
2013-14 20 6.94 6.79
2014-15 20 4.5 4.5
2015-16 21.96 19.76 19.76
2016-17 21.96 19.48 19.48
46
Name of the Department/Disciplines
Number and Names Departments/ Disciplines (with opening year)

Sr No Department Year of opening
01 Biotechnology
02 Natural Products 2007
03 Pharmaceutics
04 Medicinal Chemistry
05 Pharmaceutical analysis 2010
06 Pharmacology& Toxicology
07 Medical Devices 2012
41
4. Students
Degrees/programmes offered and Subjects offered (with year) with
admission status
MS/MBA/M.Tech/Ph.D Discipline No. of students admitted
2015-16 2016-17
MS 7 56 74
Disciplines
Ph. D NIL 9 9
5. Teacher-Student ratio : 1: 10 (14 Faculty : 140 students)
6. Employability/ Placements Status:-

List of companies participated in the year 2016 Placement
Torrent pharmaceuticals Ahmedabad, Cadila Pharmaceuticals Ltd Ahmedabad,
Zydus Healthcare Ltd Ahmedabad, INTAS Pharmaceuticals Ahmedabad,
Piramal Healthcare Ltd Ahmedabad, Sun Pharmaceuticals Ltd Vadodara,
Sahjanand Laser Technologies ltd Gandhinagar, Lupin Pharmaceuticals Pune 100%
7. Recognition to Faculty:
As an initiative to establish international collaboration NIPER Ahmedabad has
started theme based research collaboration with faculties of Harvard Medical School
and MIT, USA. The present focus area of collaboration is Neurodegenerative
diseases. The faculties of NIPER Ahmedabad are in collaboration with following
foreign universities:
8. Peer review system:
NIPER Mohali carried out peer review of NIPER Ahmedabad from 5-6 May 2016.
47
9. Research:
The Institute conducted research in Diabetes, Cancer, Neurodegenerative
Disease, Infectious diseases, Tissue repair, regeneration and Medical Implants.
10. Awards:
Gandhiyan Young Technological Innovation (GYTI) awarded at Rashtrapati
Bhawan.
11. Patents and Commercialisation: 03 Patent has been filed. onwards.
42
Impact of NIPER :
NIPER Ahmedabad is being regarded as one of the best centres of

Pharmaceutical Education which is evident from the Participation of top ranking Pharma
Companies in placement activity and 100% placement of students. At the time of
admission counselling NIPER Ahmedabad is among the top choices of the students.
48
Various events carried out by the institute.
43
5.5 NIPER Guwahati

NIPER Guwahati started functioning in 2008 under Mentor Institute Guwahati
Medical College Guwahati, Assam. In absence of Board of Governors, Steering
Committee under the Chairmanship of Secretary (Pharma) look after administrative
work in NIPER Guwahati. Dr. USN Murthy is Director of the Institute from 3.11.2016
onwards.
1. Achievements:-
(a) Ph.Ds– 21 (enrolled), Degrees awarded – 07, Thesis submitted-01
(b) Total M.S. (Pharm.) (since inception)- Students enrolled – 285
Graduated - 222 (61 students are currently pursuing their P.G. courses)
(c) Among the graduated students, many of them got admission into Ph.D. programs
in various National & International Universities/Institutes. Rest of the students got
placed in various Pharmaceutical Industries and Consultancies viz., Novartis,
Novo Nordisk, Biocon, Quintilles, etc.
(d) Publications: In total, 85 research papers have been published in various National
and International Journals.
2. Details of faculty & staff:-.
Director : 01
Academic Staff: Assistant Professors : 03
Lecturer : 01
System Engineer & Faculty (Application of Computers) : 01
DST Women Scientist : 01
Guest Faculties : 15
Non-Academic Staff : 21
3. Total Allocation by the Government during the last 4 years.

(Rs. in crores)
2013-14 18.8 3 2.88
2014-15 21 4 3.91
2015-16 21 21 21
2016-17 19.50 19.50 19.50 49
4. Students:-
i) Degrees/programmes offered and Subjects offered (with year)
Masters/ MS/MBA/ Discipline
Doctoral
M.Tech/Ph.D.
2015-16 2016-17
Masters MS (Pharm) Pharmacology and Toxicology 18 20
44
Masters MS (Pharm) Biotechnology 5 7
Masters M. Pharm. Pharmacy Practice 3 8
Doctoral Ph.D. Pharmacology and Toxicology 2 2
Doctoral Ph.D. Biotechnology 1 2
Doctoral Ph.D. Pharmacy Practice 1 1
5. Teacher-Student ratio: 1:5

6. Employability/ Placements Status
In the academic session 2015-16, 9 students got admission into Ph.D programmes
in reputed national institutes like NISER; NIPER-Mohali; NIPER-Hajipur; IIT-Guwahati;
NIPER-Guwahati and INST, Mohali. Another 11 students have been recruited by
different companies like Novartis; Novo Nordisk; Shree Dhootapapeswar Ayurvedic
Research Foundation (SDARF); Glocal School of Pharmacy, Glocal University,
Saharanpur; Global Data Research Center, Hyderabad; Quintiles etc. through on/off
campus placement. Two students have been selected for BCIL internship program.
7. Recognition to Faculty
Dr. Ranadeep Gogoi, Assistant Professor, Department of Biotechnology, NIPER-
Guwahati participated in the In-Residence Programme for Inspired Teachers held from
23rd – 29th April, 2016 at Rashtrapati Bhavan, New Delhi.
8. Peer review system

NIPER Ahmedabad visited from 26th-28th April 2016 to analyse the progress of
NIPER-Guwahati on several aspects and have given a good review which has been
uploaded on the Institute’s website.
9. Research
50
The Institute conducted research in Biotechnology, Cancer, Pharmacology &
Toxicology, Pharmacy Practice, Pharmacovigilance and Haemovigilance. Ph.D.
students currently enrolled: 13 (07 Pharmacology & Toxicology, 04 Biotechnology & 02
Pharmacy Practice)
10. Patents and Commercialization:
The institute is currently in the process of submitting one patent application in the
area of Biopharmaceuticals. It will be further explored for its commercial value.
45
11. Impact of NIPER:

The establishment of NIPER-Guwahati has given a strong boost to the promotion
of Pharmaceutical Education & Research in the North East region of India. Research
efforts of NIPER Guwahati have revived the studies on medicinal value of local herbs of
North East Region against various diseases. NIPER-Guwahati is further moving ahead
in the field of Biopharmaceuticals and is the only NIPER to have a Synthetic Biology
Laboratory, which is listed among the Indian Synthetic Biology labs.
12. Various events carried out by the institute:-
Animal House Eperiments

5.6 NIPER Hajipur
NIPER Hajipur started functioning in 2007 under Mentor Institute Rajendra
Memorial Research Institute of Medical Sciences (RMRIMS), Patna. In absence of
Board of Governors, Steering Committee under the Chairmanship of Secretary
(Pharma) look after administrative work in NIPER Hajipur. Dr. Pradeep Das is the
Project Director from 2007 till date.
1. Achievements:-
The Institute has awarded 263 students their Master’s degree since its inception.
2. Details of faculty & staff are appended below:-
Academic : 9 (on contract)
Non-Academic : 10 (on contract) 51
3. Total allocation by the Government during the last 4 years:-

(Rs. in crores)
Year BE RE Total Release
2013 – 14 3.70 3.50 3.50
2014 - 15 4.00 4.00 4.00
2015-16 6.00 6.00 6.00
2016-17 6.00 5.00 5.00
46
4. Students:-
Degrees/programmes offered and Subjects offered (with year) with admission
status
MS/MBA/ Discipline No. of students admitted
M.Tech/Ph.D
2015-16 2016-17
M S Pharm Biotechnology 04 10
M S Pharm Pharmacoinformatics 08 13
M Pharm Pharmacy Practice 13 11
PhD Biotechnology 03 03
PhD Pharmacoinformatics 01 01
PhD Pharmacy Practice 02 02
5. Teacher-Student ratio 1:10

6. Employability/ Placements Status:
Most of the students passed out from the Institute have got their jobs at suitable
places.
7. Teachers:
i. Recognition to Faculty: Faculty of the Institute has been invited for delivering
lectures at different National level conferences. They have been invited as
examiners in examinations and viva at Universities/Institutes.
ii. Peer review system: Performance of the faculty is being evaluated by renowned
scientists of the country on annual basis. The annual contract of employment of
the faculty is renewed on that basis.
8. Research:
The Institute conducted research in the fields of Biotechnology,
Pharmacoinformatics, Pharmacy Practice, Cancer, HIV, Leishmaniasis and tRNA
modification and their role in protein synthesis.
9. Impact of NIPER:
NIPER Hajipur has successfully produced 263 students in three disciplines

52 namely, Biotechnology, Pharmacoinformatics and Pharmacy Practice who are either
employed in different pharmaceutical industries or pursuing their higher education in
different institutes or universities across the globe. Many of the ex-students are engaged
as faculty at different institutions.
47
5.7 NIPER Hyderabad

NIPER Hyderabad started functioning in 2007 under Mentor Institute Indian
Institute of Chemical Technology (IICT), Hyderabad. In absence of Board of Governors,
Steering Committee under the Chairmanship of Secretary (Pharma) looks after
administrative work in NIPER, Hyderabad. Dr. S. Chandrasekhar, Director CSIR – IICT
is the Project Director from 3rd Nov, 2016 till date.
1. Achievements:-
Master Students Passed Out : 598
Students pursuing Ph.D course : 71
Doctoral degree awarded : 10
Patents (filed) : 07
Research Publications : >300
Sanctioned extramural research projects : 18
Total allocation by the Government during the last 4 years:-

(Rs. in crores)
Year BE RE Total Release
2013-14 25.00 23.00 23.00

2014-15 22.00 14.00 14.17
2015-16 35.00 35.00 35.00
2016-17 35.00 35.00 35.00
2. Teacher-Student ratio
Faculty: Student ratio is 1:12
Various reputed Companies like Novartis, Biocon, Dr Reddy’s, GVK, Mylan,
AstraZeneca, Shasun, Lupin, Aurobindo Biological E etc.participated in campus
selection/placement. The status of percentage of last few years placements status of in
campus students is as follows:
Year 2011 2012 2013 2014 2015 2016
53
In campus Placements (%) 91 88 85 82 82 80
4. Teachers
The Institute has some of the talented and dedicated faculty who come from the
best institutions around the world. Associate fellow of AP Academy of Sciences were
conferred to seven faculty of Institute for their outstanding contributions in scientific
research.
48
Peer review system: The performance of the faculty is assessed periodically. The
assessment is based on the student feedback, output from the research activities and
contributions to institutional growth.
5. Research
Active research areas: Focus areas: cancer, diabetes, anti-infective
9 Design and synthesis of new chemical entities
9 Development of screening assays
9 Development of process & scale up technologies
9 Novel drug delivery systems viz., nano-technology in drug delivery
9 Development of new bio-analytical methods
9 Drug metabolism and pharmacokinetic studies
Awards:-
a) Angelika Bierhaus Award 2016: by NEURODIAB (Diabetic Neuropathy

study group of EASD) – 2016
b) Associate Fellows of Telangana Academy of Sciences by Telangana
Academy of Sciences
c) R.V. Patil PharmaInnova Best Research Guide Award in Pharmacology
category
6. Innovation / knowledge transfer

(i) Patents and commercialization- 7 patents filed
(ii) Research income earned from Industry- 33 Lakhs
(iii) Citation per faculty- Average 440 citations per faculty
7. Impact of NIPER:
Creating excellent human resources by imparting high quality education and
training in pharmaceutical sciences which would help the pharmaceutical industry.
Serving as an excellent research institute by focusing on thrust areas of national and
international relevance. Fostering academic and industrial collaborations to address
some of the key issues in the pharma sector.
Various events/ Workshops carried out by the institute:-
54 Date Activity name Target group
9th July 2016 Workshop on "Emerging Trends In Pharmaceutical Academia
Sciences"
12th & 13th Quality Management in Bulk Drug and Formulation Academia & Industry
August 2016 Manufacturing" @ NIPER Hyderabad
49
5.8 NIPER-Kolkata
NIPER, Kolkata is presently housed at the Indian Institute of Chemical Biology
(IICB) – a premier Institute of the Council of Scientific & Industrial Research (CSIR),
India, which is the Mentor Institute. In absence of Board of Governors, Steering
Committee under the Chairmanship of Secretary (Pharma) looks after the administrative
work of the institute. Dr. V. Ravichandiran, Director is the Director of the Institute since
6.7.2015.
1. Achievements till date:

Since inception, till date 325 students have been graduated. Among them, 220 are
engaged in companies and academic institutions. Out of the seven batches, 66 students
are carrying out Ph.D. in institutes including 12 in abroad and out of them 12 have been
awarded the degrees.
2. Total allocation by the Government during the last 4 years:-
(Rs. in crores)
. Allocation BE Allocation RE Total Release
2013-14 04.50 04.50 04.40
2014-15 05.00 04.38 04.38
2015-16 08.00 08.00 06.30
2016-17 08.00 08.00 08.00
3. Teacher-Student ratio : 1:11
Students are satisfied with the mode of teaching and project work carried out by
them. 55
4. Employability/Placements Status:
(i) Year wise Companies participated in campus selection/placements: Since

inception, number of Pharma Companies came to NIPER-Kolkata to recruit
students.
(ii) Placements status: in campus/off campus: Most of the students have been
absorbed in the industries, colleges and research institutes. A number of students
50
are pursuing higher studies within the country as well as abroad. Placement was
achieved for these students according to their options for employment in companies
as well as in centres for teaching and higher studies.
Placement status during last two years
M.S. (Pharm.)
Year (Batch) Total No. of students No. of students placed
2013-2015 (7th) 49 20
2014-2016 (8th) 42 29
5. Peer Review System: Conducted from 28th to 29th April, 2016.

6. Research:
a. Active Research Areas: Synthetic and plant based drug discovery,
immunology and immune diagnostics, cellular and molecular biology,
recombinant DNA technology and monoclonal antibody technology, novel
drug delivery systems, chemical and biochemical process technology, etc.
b. Research Publications/Institution and per Faculty and High Impact
factor: 35 Nos. Research papers have been published in renowned
international journals from the project work of the MS (Pharm.) students.
7. Awards:
i. Certificate of Achievement Gold Award awarded to Dr V. Ravichandiran, Director,
NIPER-Kolkata at UNIVERSITI TEKNOLOGI PETRONAS (UTP).
ii. Certificate of Best Research Award also given to Dr V. Ravichandiran,
Director at UNIVERSITI TEKNOLOGI PETRONAS (UTP)
8. Patents and Commercialisation: Nil
56 9. Impact of NIPER:
i. A total of 325 students have graduated.

ii. 220 students are engaged to work in companies/institutions.
iii. 35 Research papers have been published.
10. Various events/workshops organized by the institute:-

Date Activity name Target group
th
28 May,2016 Meeting of Scientific Advisory Committee (SAC) Institutional
th
20 June,2016 NIPER-Kolkata and Industrial Partners Meet For all students &
staff
51
21st June,2016 Observance of International Day of Yoga For all students &
staff
st
21 June,2016 Seminar on For all students &
x Pharmaceutical Research Program & staff
Infrastructure at University of Rhode
Island.
x Nutraceuticals from Natural Products
25th July to 5th National Skill Development and Hands-on Training For all students
August,2016 on Quality Control of Biologicals” for Pharmacy Post
Graduate Students of NIPER, Kolkata
th th
29 – 30 July, National Workshop on TU&PP For all students &
2016 staff
th
18 August, 2016 Rare Disease Course Launch Program For all students
5.9 NIPER- RAIBARELI

NIPER Raebareli stated functioning in 2007-08 under Mentor Institute Central Drug
Research Institute (CDRI), Lucknow, NIPER, Raebareli. In absence of Board of
Governors Steering Committee under the Chairmanship of Secretary (Pharma) look
after administrative work in NIPER Raebareli. Dr. Swaran Jeet Singh Flora is Director
from 1st Nov, 2016 to till date.
1. Achievements:- Total 222 passed out since inception of the Institute.
2. Academic/Non-Academic staff:-
Position In Position (Sanctioned) Vacancy
57
Director 01 00
*Manpower – Academic
In Position Faculty Vacancy Total
Total 07 01 08
*Manpower – Non-Academic
Department Position In Position Vacancy
Total 18 03
*The Institute recruits teachers/staff on yearly contractual basis
52
3. Total fund allocation by the Government during the last 4 years:-

(Rs. in crore)
2013-14 4.50 4.70 4.50
2014-15 15.00 4.45 4.45
2015-16 7.00 5.50 5.50
2016-17 7.00 6.25 6.25
4. Students:-
Degrees/ programmes offered and Subjects offered (with year) with admission
status
M.S. (Pharm.) No of Students Admitted
2015-16 2016-17
Medicinal Chemistry 17 16
Pharmaceutics 13 13
Pharmacology & Toxicology 06 06
Total No. of M.S. (Pharm.) Students Admitted & Passed out in NIPER, Raebareli Till Date
Sl. No. Batch M.S. (Pharm.) Discipline No. of Total No. of Students
Students Admitted
Med. Pharma- P&T Admit-ted Drop- Passed Out Failed
Chem. ceutics ped
1 2008-10 10 10 - 20 - 20 -
2 2009-11 14 14 - 28 - 28 -
3 2010-12 15 15 - 30 - 30 -
4 2011-13 16 15 - 31 - 31 -
5 2012-14 16 16 7 39 02 37 -
6 2013-15 18 15 6 39 - 38 01
7 2014-16 19 13 6 39 01 38 -
8 2015-17 19 14 6 39 03 Pursuing -
9. 2016-17 16 14 6 36 01 Pursuing -
Total 143 126 31 300 07 222 01
5. Teacher-Student ratio - 1:10
58
Placement Status during last two years are as under:-
Batch Year Total of Students No. of Students Placed
6th 2013-15 39 15
7th 2014-16 38 16
7. Teachers:-
1. Recognition to Faculty = NA
2. Peer review system – Performance of teachers is being evaluated by
taking feedback from the students.
53
8. Research
Research Publications
Year Total of Publications
2010-11 02
2011-12 02
2012-13 04
2013-14 09
2014-15 08
2015-16 04
9. Impact of NIPER
x Creating excellent human resource by imparting high quality education in
pharmaceutical sciences.
x Serving as an excellent research institute by focusing on thrust areas of
national and international relevance.
10. Various events/workshops carried out by the institute:-
Date 18th-19th March, 2016
Activity Name 8th NIPER (RBL) – CSIR-CDRI Symposium
3rd Convocation of 5th & 6th Batch Students held on 11th December, 2015
59
8th NIPER (RBL)-CSIR-CDRI Symposium organized on 18th – 19th March, 2016
54
Dr. S.J.S. Flora, Director, NIPER-Raebareli with Staff and Students
60
55
Chapter
6
PUBLIC SECTOR UNDERTAKINGS
6.1 Central Public Sector Undertakings
6.2 Cabinet Decision on Pharma PSU
6.3 Indian Drugs & Pharmaceuticals Ltd. (IDPL)
6.6 Bengal Chemicals & Pharmaceuticals Ltd. (BCPL)
CHAPTER–6
CHAPTER 6
PUBLIC SECTOR
PUBLIC SECTOR UNDERTAKINGS
UNDERTAKINGS
6.1 Central Public Sector Enterprises (CPSEs)

There are five Central Public Sector Enterprises (CPSEs) under the administrative control of
t h e Department of Pharmaceuticals. Of the five PSUs, three viz. Indian Drug &
Pharmaceuticals Limited (IDPL), Hindustan Antibiotic Limited (HAL) & Bengal Chemicals &
Pharmaceuticals Limited (BCPL) are sick and referred to Board for Industrial & Financial
Reconstruction (BIFR). Rajasthan Drugs & Pharmaceuticals Limited (RDPL) has also reported
losses for since the year 2013-14. Karnataka Antibiotic & Pharmaceuticals Limited (KAPL) is the
only profit making CPSE.
(As on 2015-16)
HAL IDPL RDPL BCPL KAPL
Established in 1954 1961 1978 1980 1981
Nationalized
Classification Sick Sick Incipient Sick Sick Profit making
Net worth -488.10 - 7147.23 -24.65 -184.60 127.81
( in cr.)
Turnover 15.12 84.22 36.53 88.19 326.90
( in cr.)
Operating -52.43 11.33 -13.50 13.33 33.97
profit/loss( in cr.)
Liabilities ( in cr.) 1250 10779.20 121.05 230.55 9.06
Referred to BIFR 1997 1992 No 1992 NA
No. of employees 2000 (in 11000 (in 191 (in 2013) 1467 (in 1992)
1997) 1992)
Employees as on 1010 42 152 332 712
date
Officer level 250 7 52 70 239 63
Worker level 760 35 100 262 473
VRS earlier given 2007- 485 1992 - 4000 NIL 2006 - 2016 2015
employees 2003 - 6000 180 employees 2 employees
Total land 267 acre 2003 acre 9.35 acre 72.89 acre 37.34 acre
Leasehold Nil 1022 acre 9.35 acre 1.10 acre Nil
Freehold 267 acre 981 acre Nil 71.79 acre 37.34acre
Initiatives taken to improve the performance of CPSEs during 2016-17 are as follows:
57
1. Performance Management – Regular review of performance of CPSEs – Performance

review meetings of all CPSEs was held.
2. Pharma Park Development – The matter of Pharma Park in IDPL, Hyderabad/IDPL,
Rishikesh/IDPL, C h e n n a i is under consideration of Government of India.
3. Status of WHO-GMP in RDPL – The Company has embarked upon expansion,
modernization and upgradation programme (Phase II) to quality for WHO-GMP certification
to become eligible for exploring International Markets as well as for participating in the
Internationally Funded Projects of Government of India and other Government.
4. In BCPL – Ointment & Betalactam Block and Panihati Project have been completed while
Cephalosporin Block is under commissioning. Besides this, OSD Project & ASVS Project
are being commissioned
6.2 Cabinet decisions on Pharma PSUs

A rehabilitation proposal for the sale of part of surplus and vacant land of
Hindustan Antibiotics Limited (HAL) for meeting its mounting liabilities was considered
by the Cabinet on 27.04.2016. While considering the proposal, the Cabinet had directed
that the following Ministers may comprehensively examine the status of all
Pharmaceutical Companies in the public sector and suggest the future course of action:
(i) Minister of Finance; Minister of Corporate Affairs; and Minister of

Information and Broadcasting;
(ii) Minister of Road Transport and Highways; and Minister of Shipping and
(iii) Minister of Chemicals and Fertilizers.
The Ministers comprehensively examined the status of all Pharmaceutical

Companies in the public sector in their meetings on 19.05.2016, 19.12.2016 and
20.12.2016 and noted that all PSUs except KAPL are sick or incipient sick. IDPL, BCPL
and HAL were declared sick and formally referred to BIFR since 1992, 1993 and 1997
64
respectively. The earlier revival/rehabilitation packages of IDPL, HAL & BCPL have
failed to achieve desired results. The production activities in RDPL too have stopped
after fire in the plant in October, 2016. HAL and RDPL are not in a position to even pay
the salaries to their employees. All these companies possess substantial land assets.
After detailed deliberations, the Ministers recommended as under:
i. Only that much of surplus land of HAL, IDPL, RDPL and BCPL as would be
required to meet the liabilities be sold through open competitive bidding to
Government agencies and the outstanding liabilities be cleared from the sale
58
proceeds. Voluntary Separation Scheme/ Voluntary Retirement Scheme also be

implemented in these PSUs to pave way for their closure. Remaining part of the
land should be managed in accordance with guidelines of Department of Investment
and Public Asset Management (DIPAM) and Department of Public Enterprises
(DPE) in this regard and if need be, vested in a SPV created for this purpose.
ii. After liabilities have been met, balance sheet cleansed and the Voluntary
Separation Scheme/Voluntary Retirement Scheme effected, the Department to
close IDPL and RDPL and HAL and BCPL be put up for strategic sale.
iii. While taking a decision to close the PSUs, the Department may also explore the
possibility of hiving off the subsidiary companies of HAL and IDPL for private
participation, wherever found viable.
Cabinet in its meeting held on 28.12.2016 approved the recommendations of
the Ministers’ as mentioned above.
6.3 Indian Drugs and Pharmaceuticals Ltd. (IDPL)

Background:
Indian Drugs & Pharmaceuticals Limited (IDPL) was incorporated as a public
limited company on 5th April, 1961 under the Companies Act, 1956. The Registered
Office of the Company is located at IDPL Complex, Dundahera, Gurgaon and its Head
Office at SCOPE Complex, Lodhi Road, New Delhi. The main objectives of the company
were to create self-sufficiency in respect of essential life saving medicines, to free the
country from dependence on imports and to provide medicines to the millions at
affordable prices. IDPL was basically conceived and established as a part of Healthcare
Infrastructure and has played a pioneering infrastructural role in the growth of Indian
Drugs Industry base.
IDPL has three main Plants at Rishikesh (Uttarakhand), Gurgaon (Haryana),
Hyderabad (Telangana) and two 100% wholly owned subsidiaries, namely, IDPL (Tamil 65
Nadu) Ltd. Chennai (Tamil Nadu) and Bihar Drugs & Organic Chemicals Ltd. (BDOCL)
at Muzaffarpur (Bihar). In addition, IDPL has one Joint Venture, promoted in
collaboration with Industrial Promotion & Investment Corporation of Orissa Limited
(IPICOL) the State Government of Odisha, namely Odisha Drugs & Chemicals Ltd.
(ODCL) Bhubaneswar.
Past Achievements :
The main objectives of setting-up IDPL were not to earn profits but to encourage
indigenous production of pharmaceuticals and to support various health programmes of
59
the Central Government. IDPL did reasonably well on this account despite the fact that it
was the first integrated and monolithic venture in the Public Sector engaged in
production of low margin products. IDPL earned Profit before Depreciation, Interest &
Tax (PBDIT) from 1965 to1968 and again from 1971 to 1974. It earned net profit from
five years continuously from 1974 to 1979; the Company lost its profitability primarily
due to change in Government policy about import of bulk drugs from supply to
Pharmaceuticals Industry. The Imports, which were canalized through IDPL till 1979
were entrusted to State Trading Corporation (STC). IDPL was thus divested of a profit
making segment. Today, it can fulfil other needs to meet gaps in Public Health by
supplying essential life saving drugs.
Ointment Manufacturing Unit FBD & RMG
Reasons of sickness:
The IDPL continued to function on the basis of its old model of sixties which lost its
relevance to a great extent by eighties. In the circumstances, the net worth of the IDPL
became negative in 1982-83. The main causes were -
(i) large monolith-type integrated production facilities (typical model followed in
1950s-1960s) producing chemicals, Bulk Drugs and Formulations;
(ii) Out dated Plant & Machinery and obsolete technology for Bulk Drugs (but for
66
formulations not outdated)
(iii) Excess manpower (13283 in 1983-84), high Wages/Salary bill and maintenance
of huge Township, Schools and Hospitals in all locations of IDPL.
(iv) Frequent changes at top level Management (average tenure of Chairman &
Managing Director was 18 months)
(v) Medicines manufactured by IDPL were under Drugs Price Control Order (DPCO)
by the Government prior to liberalization in 1991.
(vi) Shift in Government policy resulting in shifting of the canalization agency from
IDPL to State Trading Corporation (STC).
60
(vii) Intense competition from private Pharmaceuticals Sector Companies which

did not have to bear burden of social infrastructure of setting up and
maintaining Townships, Schools, Hospitals etc. and had learner production
facilities. Due to shortage of Working Capital Production has been stopped in
October 1996 at Rishikesh, Hyderabad & Muzaffarpur Plant.
Revival status since 1.4.1994

The Board for Industrial & Financial Reconstruction (BIFR) declared IDPL as a
sick industrial Company on 12th August. 1992. On 10.2.1994 BIFR approved the
Rehabilitation Scheme under Section 17(2) of SICA for its implementation w.e.f.
1.4.1994. The package sanctioned by BIFR in 1994 failed primarily because (i) full funds
were not released to the Company as envisaged (ii) capital restructuring was not done
(iii) banks did not provide adequate working capital requirements (iv) working capital
were diverted to meet fixed expenses of subsidiary units. (v) Land could not be sold (vi)
sales targets were fixed at very ambitious levels. On 23.1.1996, BIFR appointed
Industrial Development Bank of India (IDBI) as Operating Agency (OA) for Techno-
Economic Analysis and preparation of Revival Package. The issue of revival of the
company remained pending in BIFR as well as with the Govt. while attempts were made
in 2001-02 to privatize the Company. OA (IDBI) however, did not find any proposal
worthy of recommendations to BIFR.
After failure to privatize IDPL, BIFR ordered its winding–up on 4.12.2003. Govt.
filed an appeal before Appellate Authority for Industrial Financial Reconstruction
(AAIFR) on 10.2.2004 against BIFR order. AAIFR admitted the appeal filed by the
Government on 2.8.2005 and directed that a Road Map for revival of IDPL be submitted.
Ministry/ Department constituted an Expert Committee under the Chairmanship of
Director NIPER and Technical Audit of the Plants & Machineries carried out by the
Committee. The Committee found the Plant & Machineries for production of formulations 67
in a reasonably good shape which could be optimally utilized with minimal investment
for compliance of Scheme-M requirements. It was also opined that the emerging
position of IDPL in the present market scenario was to be conceptualized. IDBI
supported the recommendations of the Expert Committee. Having regard to these
developments, AAIFR in its hearing held on 13.9.2005 set aside the impugned order of
BIFR dated 4.12.2003 and remanded the matter back to BIFR for taking further action
for Rehabilitation of IDPL and to pass further orders in accordance with Law.
61
The Draft Rehabilitation Scheme (DRS) was prepared by IDPL in consultation

with ICRA Management and submitted to the BRPSE for consideration and
recommendation. After approval of the BRPSE, a Note for Cabinet Committee on
Economic Affairs (CCEA) was prepared and submitted for approval on 11.5.2007. The
Note was considered by CCEA in its meeting held on 17.5.2007 and it referred the
matter to Group of Ministers (GoM). GoM in its meeting held on 11.10.2007 advised that
IDPL’s revival plan should be based on public interest goals and ensuring the viability of
the Company. In view of the observations made by GoM, IDPL appointed a leading
consultant Company E&Y to carry out the feasibility study. E&Y report was submitted to
the Ministry/DoP.
A revised DRS again prepared in consultation with IDBI (OA) taking cut off date
as 31st March, 2011. In the BIFR meeting held on 20.8.2014 cut off date was approved
as 31.3.2014. Accordingly, the revised updated DRS was prepared taking cut off date
31.3.2014 and submitted to the DoP/ Ministry in January 2015. the Cabinet in its
th
meeting held on 28.12.2016 recommended for closure of IDPL on 9 January, 2017after
meeting its liabilities by selling the surplus land.
IDPL 100% WHOLLY OWNED SUBSIDIARIES
IDPL (Tamil Nadu), Chennai.
IDPL (Tamilnadu) Chennai was incorporated in September, 1965. Initially, it was
a Surgical Instruments Plant and later diverted for Formulations Plant. In terms of revival
package approved by BIFR in 1994 the Plant was converted into a 100% wholly owned
subsidiary in the name and style of IDPL (Tamilnadu) Limited, Chennai with effect from
1.4.1994. IDPL (Tamilnadu) is a Schedule-M compliant Plant and engaged in
manufacture about 20-25 pharmaceuticals formulations. The production achieved for the
F.Y. 2015-16 was Rs. 10.28 crores.
68
Dissolution Apparatus-Quality Control Wet Lab-I Quality control

62
Bihar Drugs & Organic Chemicals Ltd. (BDOCL, Muzaffarpur

Bihar Drugs & Organic Chemicals Ltd., Muzaffarpur was incorporated in 1979,
converted into 100% wholly owned subsidiary w.e.f. 1.4.1994. At present there is no
production activity in BDOCL since November, 1996.
Orissa Drugs and Chemicals Ltd (ODCL) (Joint Venture) of IDPL and Government
of Odisha;
Orissa Drugs & Chemicals Limited (ODCL) was incorporated in 1979 and
commissioned for production from September, 1983. ODCL is a Joint Venture promoted
by Indian Drugs & Pharmaceuticals Ltd. (IDPL) holds 51% of the equity shares and
Industrial Promotion & Investment Corporation of Orissa (IPICOL) hold equity shares of
49%. BIFR passed orders for winding up in April, 2003 under the provisions of SICA
Act, 1985. High Court of Orissa had appointed a provisional Liquidator. This has since
been stayed by a larger Bench of the Odisha High Court. ODCL presently is
manufacturing formulations in the form of Tablets, Capsules, Powder, ORS and
Injectables etc. ODCL Plant is Schedule-M compliant and production for the F.Y. 2015-
16 was Rs.21.50 crores which was the highest ever achieved and operational profit Rs.
145.50 lakhs .
69
63
IDPL TODAY - Presently IDPL is engaged in manufacturing about 130 formulations. In-
house production of formulation during the year 2015-16 was Rs. 87.94 crores and
sales Rs. 86.41 crores.
Production & Sales Performance:

Govt. had sanctioned fund for modernizing/ schedule -M compliance of
Rishikesh, Gurgaon, IDPL(TN) Chennai and ODCL, Bhubaneswar Plants. Govt. of also
release fund of Rs 15.00 Cr for making Hyderabad Plant in operational. This plant is
almost ready and can be utilized for production of many life saving drugs namely HIV,
TB drugs etc. This is going to be WHO GMP compliant unit which will help it to enter
export markets also. The production achieved after 2011-12 to 2015-16 is as under:
Last year IDPL achieved record in-house production of Rs 88 crores (approx.)
70
87.94
71.31
100 58.71 62.84
50.79
80 42.35
60
40
20
0
64
Sales :
Sales performance shows a continuous growth in the company. The supplies are being
made in time. The delivery period of supply is 30-40 days, but many a times IDPL has
supplied the medicines even before the delivery date and customers are appreciating
this.
86.41
100 60.71 60.17 65.39
52.44
50
Modernization of Plants with the assistances of Government of India

The Up-gradation and Modernization of IDPL Plants are in progress. It is
expected to complete the modernization work of its Plant at Gurgaon and and Rishikesh
very soon. Rishikesh Plant is Schedule ‘M’ compliant and is WHO-GMP compliant and
received COPP for 4 products. Whereas Gurgaon Plant is also Schedule-M for Tablet
Section. IDPL will re-start its Hyderabad Formulation Unit during the current F.Y. 2016-
17.
Product profile and Range:
Presently, IDPL is manufacturing nearly 90 (PPP) products and 25-30 (Non-
71
PPP) products in the form of Capsules, Tablets, Dry Syrup, Liquid Oral and Injection,
based on mainly following therapeutic groups: Antibacterial/Anti-infective, Analgestic
/Anti-inflammatory, Gastrointestinal, Respiratory Tract, Contraceptive, Vitamins/ Mineral,
Anti allergic, Anti-fungal , Anti-malarial, Anti diabetic Cardiovascular.
New Products launched – Cefexime 100 mg, & 200 mg., Cefuroxime, Axetil 250mg &
500mg., Aceclofenac 100mg, Aceclofenac 100mg. + Paracetamol 500mg, Glimpride
1mg & 2mg, Atorvastatin 10mg, & 20mg., Ciporal 250mg & 500mg, Metformin 500mg,
Pentoprazole 40mg.
65
Popular Brands: Deacos syrup, Sukcee Tab, Cebxin-Z are the popular brands of IDPL.
Marketing: Share of Institutions and retail: Company is only supplying to Institutional
and Govt Departments who place orders on PPP. As per PPP Govt Institutions can buy
103 medicines from 5 CPSU at NPPA certified prices. Major Institutional of IDPL are
ESIC, Ministry of Health & Family Welfare, Defence, Railways, State Governments/
Corporations and Public Sector Enterprises Hospitals who place orders under different
categories of Therapeutic Medicines. Apart from above the IDPL is fully supporting
Pradhan Mantri Jan Aushadhi Pariyojana Programme of Govt of India
Distribution network if any; Company is selling its products to Institutions through
distribution networks of 19 Depots (C&F) located all over the country.
Manpower
72 Company has 45 regular employees and 136 on contract as on 31.12.2016
including 100% wholly owned Subsidiaries. The company has not been permitted to go
for regular appointment. Company hired contractual manpower in statutory and critical
positions only to look after the day-to-day affairs of Production, Sales and other
essentially activities only.
IDPL has also played a major role in the strategic National Health Programmes
like Family Welfare Programme & Population Control (Mala-D & Mala-N) anti-malarials
(Chloroquine) and prevention of dehydration (ORS) by providing quality medicines. IDPL
has encouraged indigenous production and intervention for price control in market by
66
manufacturing Generic Grugs. IDPL has been supporting Government in meeting

emergent situations arising due to National calamities like Cyclone, Flood, and
Earthquake etc. Last year in Odisha, Uttrakhand and J&K floods. IDPL contributed
significantly by providing lifesaving medicines on time.

Hindustan Antibiotics Ltd. (HAL), a wholly owned Central Public Sector
Undertaking under the administrative control of the Departments was incorporated in
1954. The registered office and manufacturing facilities of the company are located at
Pimpri, Pune, Maharashtra. The Company was set up for manufacturing of bulk drugs
and lifesaving drugs and formulations. Over the years several new products were added
/ undertaken for manufacturing like those used in agriculture and veterinary medicines.
The authorized share capital of the Company is Rs.100 crores. As on 31st March, 2016,
the subscribed and paid-up share capital is Rs.71.71 crores.
Production and sales:
(Rs. in Crores)
2013-14 2014-15 2015-16 (Prov.)*
Production 27.66 17.28 14.45
Sales Turnover 30.11 18.54 15.12
Net Profit(Loss) ( 84.23) (70.55) (74.68)
*Provisional
HAL is passing through critical financial crisis due to shortage of working capital
required for running its operations. Salaries of the employees and many of the statutory
payments like Provident Fund, Gratuity, Income tax, Sales Tax etc. are also
outstanding. The working capital facilities are also not forthcoming from the Banks as
the Company’s account has become NPA. The Company is incurring losses since 1992
and was declared sick in 1997. Rehabilitation plan of 2006 for Rs. 137.59 crore (Rs.
80.63 crore budgetary support and interest free loan Rs. 56.96 crore) did not succeed.
73
Second rehabilitation proposal for infusion of Rs. 670.46 crores was proposed.
However, the Cabinet approved selling of its surplus and vacant land to
Government/PSUs/Autonomous Bodies to meet its liabilities. The Government also
approved waiver of Rs. 307.23 crore of Central Government loans and deferment of
liabilities amounting to Rs. 128.68 crores and sanctioned immediate loan of Rs. 100
crores for meeting salaries, wages and critical expenses. It has been further decided to
strategically sell the Company after meeting its liabilities, effecting VRS/VSS and
cleansing the balance sheet.
67
PRODUCTION:
The total value of production during the year 2015-16 is Rs.14.45 crores as
compared to Rs.17.28 crores during the previous year.
In addition to Cephalosporin and Penicillin powder injectable, Tablets, Capsules,

Agriculture product (Streptocycline) and Narcotic Detection Kit contributed to the
production. Capacity utilization and the production of various products were affected
due to non-availability of bulk and packing material as per the plan due to working
capital shortage. In the total production of Rs. 14.45 crores, single product
Streptocycline contributed Rs.10.95 crore ( 75.76% of total Production) against Rs. 9.57
crores in the previous year. Narcotic detection kit production value was 0.78 crores
(5.4% of total production).
Since new high speed Form-Fill-Seal Machine for Streptocycline pouch was
commissioned in Nov’15, capacity of Streptocycline pouch production is enhanced to
180 lacs pouch/annum from 72 lacs pouch / annum.
SALES:
During the year, the Company achieved sales turnover of Rs.1.51 crores
compared to Rs.18.54 crores during the previous year. Marketing Dept. have
successfully achieved following activities during 2015-16
a) Manufactured and supplied various range of formulations to BPPI under

Jan Aushadhi worth of Rs. 100 lacs.
b) Successfully developed and supplied skin de-contamination kits and
Prussian Blue Tablets to Institute of Nuclear Medicine and Allied Sciences
(INMAS), Defense Establishment.
c) Supplied Narcotic Kits to Narcotic Control Bureau worth of Rs. 75 lacs.
Subsidiaries:
74 Maharashtra Antibiotics & Pharmaceuticals Ltd. (MAPL) has been ordered for
winding up by BIFR and the said order has been confirmed by AAIFR. The winding up
order has been stayed by the Hon’ble High Court at Bombay, Nagpur Bench on the Writ
Petition filed by the Group of Employees of MAPL. As per the order of the Hon’ble High
Court at Bombay, Nagpur Bench, the Voluntary Separation Scheme (VSS) in MAPL has
been implemented and all the employees have been relieved under the VSS with the
help of the funds released by the Govt. of India. Additionally, the Govt. of India has also
released non-plan loan amounting to Rs.8.5 crores for payment of outstanding dues of
68
the employees of MAPL through the Company and the amount has been disbursed to
the employees of MAPL.
The operations of Manipur State Drugs & Pharmaceuticals Ltd. (MSDPL) have
been closed as per the decision made by its Board of Directors and necessary
compensation on closure of MSDPL has been paid to the employees of MSDPL through
the funds released by the Govt. of Manipur.

Karnataka Antibiotics and Pharmaceuticals Ltd. is a profit making joint sector
Company incorporated in the year 1981 [with 59% shares by Government of India and
41% shares by Government of Karnataka through Karnataka Antibiotics and
Pharmaceuticals Ltd.]. The basic objective of the company was to make available life-
saving drugs of good quality to Karnataka Government hospitals and other institutions
along with Private Medical Practitioners. The Company has WHO-GMP Certified
Manufacturing facilities for Dry Powder Injectable, Liquid Injectable, Tablets, Capsules,
Dry Syrups and Suspensions. The paid – up share capital of the company as on date is
Rs. 13.49 crores.
Production and Sales performance:
(Rs. In crores)
Years Production Sales
2013-2014 275.73 241.59
2014-2015 281.81 274.24
2015-2016 342.01 326.92
2016-2017
178.78 177.02
(Upto Sept`2016)
Past achievements:
- Mini Ratna – II CPSE
- ISO 9001 (QMS) and ISO 14001 (EMS)
75
- PIC/S Certification
Pharma – Trade
No Products Therapy Segments NLEM Monopoly Market Value
1 Grenil Group Anti-migraine No No Rs. 12.00 Crores
2 Cyfolac Group Pre & Probiotics No No Rs. 4.00 Crores
3 Remcc Group Cough & Cold No No Rs. 3.00 Crores
4 Zinfe Group Haematinic No No Rs. 2.00 Crores
5 Verclav Group Antibiotic Yes No Rs. 2.00 Crores
69
Agrovet:
Sl. No. Name of the Product Therapy Monopoly Market Value

Segments
01 K Cycline Powder (Agro) Insecticides No 5.00 Crores
02 Kalvimin Group Feed Supplement No 2.50 Crores
03 K-Live Hepato-Protective No 2.00 Crores
Distribution network:
The Company has been expanding its operations in Retail Trade Sector with a
planned effort so as to cater to the needs of the Private Medical Practitioners. The
Domestic operations spans throughout the country manned by a highly dedicated
Professional Field Force and backed by a well-knit Channel of Distribution ensuring
Karnataka Antibiotics and Pharmaceuticals Ltd.’s presence at the Metro as well as Micro
Markets.
Karnataka Antibiotics and Pharmaceuticals Ltd. has its Branches located in all
the State Head Quarters. The Company also has an excellent Distribution Network at
almost 20 Branches at Major Cities catering to the respective State areas through
Channel Marketing. The supplies are made effective through approved Stockists to
Retailers, Nursing Homes & Dispensing Doctors in the Trade Segment and directly to
Institutions in Rate Contract [RC] & Non-Rate Contract [NRC] Sectors.
Marketing:
PHARMA:
The Company has been mainly focusing on Prescription Market as Medical

Professional as the Customers, where many of the MNCs and Private Pharma Players
have a major share. The Company is also dependent on PPP Policy for Institutional
76
Business, where the concentration is on Govt. Hospitals, State Govt Hospitals,
Corporates, PSU Hospitals, Defence & Insurance. It has potential to expand in Trade
Segment & also to increase volumes by focusing on CPSE Hospitals and large
Corporate Hospitals.
AGROVET:
The Company is focusing on Agro dealers and Department of Agriculture /
Horticulture for Agro Products. Products are being focused on Veterinary Practitioners,
70
Farmers, Animal Husbandry Departments of all States and Milk Unions for Veterinary
Products and Feed Supplements.,
NEW PRODUCTS:
Sl. No. Products Therapeutic Category

1 Numol SP NSAID with Proteolytic Agent
2 Pop-e Platelet Boosting Agent
Removal of retained Placenta and for faster
3 Uterine Tonic
involution of Uterus in Farm Animals
Herbal for bloat, flatulence and colic in Farm
4 Bloat Remedy Liquid
Animals
FUTURE PLANS:
The Cephalosporin Project has started production from December 2016.
6.6 Bengal Chemicals & Pharmaceuticals Ltd.(BCPL)
Bengal Chemicals and Pharmaceuticals Limited (BCPL), erstwhile Bengal

Chemical and Pharmaceutical Works Limited (BCPW) were set up in 1901 by Acharya
Prafulla Chandra Roy, a renowned scientist and academician. Government of India
nationalised BCPW in 1980 under the name Bengal Chemicals & Pharmaceuticals
Limited (BCPL) in 1981.
The Company is Headquartered in Kolkata, BCPL is engaged in the business of
industrial chemicals (Alum), branded and unbranded generic pharmaceuticals, hair oil
and disinfectants such as phenol, naphthalene balls, bleaching powder, toilet cleaners
and floor cleaners. At present, the Company has four factories; at Maniktala and
Panihati in West Bengal, Mumbai and Kanpur.
Maniktala Unit: This unit primarily produces Division II products which include branded
as well as unbranded generic pharmaceuticals. The Company has commissioned and
started commercial operation of its Tablet, Capsule and Ointment sections of Maniktala
77
factory at Kolkata. The Injectable section is under commissioning and Company will be
able to commercialize the operation of Injectable Section in this financial year itself.
Panihati Unit: Panihati unit, located near Kolkata, primarily produces Division I (Alum)
and Division III products which include Pheneol, Naphthalene Balls, and other
disinfectants. Commercial production in most of the renovated production-blocks such
as Alum, Pheneol, Napthalene and White Tiger have commenced
Mumbai Unit: Mumbai unit produces Hair Oil under the brand name ‘Cantharidine’. The
commercial space developed has been leased out to third parties for generation of
71
additional sources of income. Commercial space of the order of 43,206 sq. ft. has
presently been leased out by the company
Kanpur Unit: Kanpur Unit, set up in 1949, primarily produces Division II products
which includes tablets and capsules and small quantity of Hair Oil.
Popular brands:
Pheneol – Lamp brand, White Tiger, Naphthalene, Cantharidine Hair Oil. The
Company was referred to BIFR in 1992. The revival package of Rs 490.60 Cr, approved
by the Government in 2006, comprised of restructuring of exiting debts on the books of
BCPL, capital investments, support for development of marketing infrastructure and
promotional measures, grant for wage revision and implementation of VRS and funds
for payment of non-Government dues. Even after restructuring, the Company continued
to run in losses. However, the financial performance is improving from 2014-15
onwards. For the half year ended on 30th September, 2016, Company not only reported
PBDIT of Rs.10.97 Crore but also reported a Net Profit of Rs.1.16 Crore which is first
time in the last 63 years history of the Company.
Plant Machinery and capacity:
SL PRODUCTS UNIT INSTALLED PRODUCTION PRODUCTION

No CAPACITY Per For (2015-16) For Ist Half (2016-
Annum 17)
For 2016-17
1 ALUM MT 8000.00 4081.92 2520.00

3 TABLETS CR 15.00 11.63 4.61
4 CAPSULES CR 15.00 7.19 2.28
5 OINTMENTS MT 60.00 37.01 20.07
6 HAIR OIL KL 600.00 151.80 60.00

7 PHENEOL KL 3000.00 1588.90 960.00
78 8 NAPTHALENE MT 450.00 123.44 72.29
9 DISINFECTANTS KL 1200.00 729.97 287.0
Modernisation of Plants(Government assistance projects and status)

(Rs. in Cr.)
Projects Investments Status
Ointment & Common items –Maniktala 29.92 Completed
Betalactam Block-Maniktala 33.53 Completed
Cephalosporin Block- Maniktala 31.34 To be completed
(Now Non-Betalactum Block)
72
Panihati Project 27.95 Completed

OSD project at Kanpur 34.44 To be completed
ASVS - Maniktala 2.90 Stopped for want of
fund
Pre-operative expenses 17.07 -
Total 177.15
Distribution network if any:

The company has a strong distribution network pan India with 10 Depots and
11 C&F Agencies.
Performance:
Details of Production, Turnover and Financial Performance are as under:
(Rs. in Crores)
Particulars 2013-14 2014-15 2015-16 2016-17 (Half-year
ended on 30 Sept.
2016)
Production 19.70 64.10 106.70 49.27
Turnover 17.06 45.84 88.19 40.44
Total Income 36.63 65.53 112.76 51.37
Gross (20.36) 1.65 11.24 10.97
Margin(PBDIT)
Interest Expenses 12.85 15.36 16.42 7.66
(Finance cost)
Depreciation 2.15 3.95 3.61 3.34
Net Profit(Loss) 1.16 (9.13) (17.32) (36.55)
DPE’s rating:
Year MOU Assessment Corporate Governance
2014-15 “Good” “Fair”
2015-16 “Excellent” “Excellent”
Future projects:
ASVS Project: The Company is planning to start ASVS Project as the product is
not available in the country at the moment in required quantity as both the Government
79
sector units namely BCPL and Central Research Institute (CRI), Kasuali, have stopped
production of ASVS for the last 10 years. Due to non-availability of fund and also due to
project cost escalation the project could not be commissioned. The total project cost for
ASVS block as on date is Rs 31.00 Cr.
MoU Targets for 2016-17:
Rs. in Cr.
Production 110.00
Turnover 90.00
73
Management of Bengal Chemical with Shri Jitendra Trivedi, Director, Department

of Pharmaceuticals, Government of India, during Annual General Meeting held on 24th
October, 2016
Seminar held on 03/11/2016 on “Public Participation in promoting integrity and

eradicating corruption”

Rajasthan Drugs & Pharmaceuticals Limited (RDPL) is a Central Public Sector
Unit in Joint Sector with a total paid-up equity capital of Rs. 4.98 crores where
Government of India (GoI) and Rajasthan State Industrial Development & Investment
Corporation Limited (RIICO, Govt. of Rajasthan) hold 51% and 49% respectively. It was
incorporated in 1978 and commercial production started in 1981. The Company has its
manufacturing facilities & registered office at Road no. 12, VKI Industrial Area, Jaipur
(Rajasthan).
The Company is engaged in production of Tablets, Capsules, Liquid Orals, ORS
Powder & Ophthalmic medicines in a Schedule ‘M’ compliant facility. The company has
a well-equipped laboratory with modern equipment like HPLC, FTIR, etc., for ensuring
high quality parameters. The company is also working towards obtaining ISO 9001:2008
& WHO-GMP certifications. The Company has enhanced its manufacturing capacities
by installing new machines and at the same time the workers have also acquired skills
80
and expertise for attaining high productivity.
The Company is engaged in manufacture and selling of medicines of high quality
at reasonable rates to the Govt. of Rajasthan, Central Government Institutions, viz
ESIC, Defence, Railways, other PSUs and also to other State Govt. Institutions. RDPL
is a partner in the novel and noble endeavor of Govt. of India in the implementation of
‘JAN AUSHADHI’ programme where quality generic medicines are made available to
the public at large in the country at affordable prices.
74
Production and Sales performance:

Rs. in crore
Years Production Sales
2013-2014 54.93 43.51
2014-2015 25.04 24.90
2015-2016 39.78 36.53
2016-2017 (Upto Oct`2016) 3.77 6.97
Product Profile:
The Company has been dealing in following products:
x Anti-Biotic
x Anti-Malarial
x Antacids
x Analgesic, Anti-Pyretics & Anti-Inflammatory
x Anti-Emetics
x Anti-Spasmodics
x Anti-Diarrhoeal / Anti-Amoebic
x Cough Expectorants
x Anti-Allergic
x Anti-Bacterials
x Anti-Fungal
x Vitamins & Minerals
x Opthalmic Preparations
x Oral Rehydration Salt (ORS)
x Anti Retro Viral
x Anti Hypertension
Future Projects:
The Company has embarked upon expansion, modernization & up-gradation
programme (Phase II) to qualify for WHO-cGMP certification to become eligible for
exploring International Markets as well as for participating in the Internationally Funded 81
Projects of GOI and other Governments. Due to fire at its plant in October, 2016, the
production activities have stalled.
75
Chapter
7
NATIONAL PHARMACEUTICAL PRICING AUTHORITY (NPPA)
CHAPTER
CHAPTER 7 – 7
The National Pharmaceutical Pricing Authority (NPPA), an independent body of
experts in the Ministry of Chemicals and Fertilizers was formed by the Govt. of India
vide Resolution published in the Gazette of India No. 159 dated 29.08.97. The functions
of NPPA, inter-alia include fixation and revision of prices of scheduled formulations
under the Drugs (Prices Control) Order (DPCO), as well as monitoring and enforcement
of prices. NPPA also provides inputs to Government on pharmaceutical policy and
issues related to affordability, availability and accessibility of medicines.
2. The Government notified DPCO, 2013 on 15th May, 2013 in supersession of
DPCO, 1995.
3. Salient features of DPCO, 2013.
x The National List of Essential Medicines (NLEM), notified by the Ministry of
Health & Family Welfare is adopted as the primary basis for determining
essentiality and is incorporated in the First Schedule of DPCO, 2013 which
constitutes the list of scheduled medicines for the purpose of price control.
x Ceiling prices of scheduled formulations are fixed based on ‘market based data’.
x Price control is applied to specific formulations with reference to the medicine
(active pharmaceutical ingredient), route of administration, dosage form / strength
as specified in the First Schedule.
x The National List of Essential Medicines 2015 (NLEM 2015) was notified by the
Ministry of Health and Family Welfare in December 2015. NLEM 2015 was
thereafter notified as the First Schedule of DPCO 2013, in March 2016, by the
Department of Pharmaceuticals.
4. The functions of the National Pharmaceutical Pricing Authority (NPPA) are:
x To implement and enforce the provisions of the DPCO, 1995 / 2013 in 85
accordance with powers delegated to it.
x To undertake and/or sponsor relevant studies in respect of pricing of
drugs/formulations.
x To monitor the availability of medicines, identify shortages, if any, and to take
remedial steps.
x To collect/maintain data on production, exports and imports, market share of
individual companies, profitability of companies etc. for bulk drugs and
formulations.
77
x To deal with all legal matters arising out of the decisions of the Authority.
x To render advice to the Central Government on changes/revisions in
Pharmaceutical policy.
x To render assistance to the Central Government in parliamentary matters relating
to Pharmaceutical pricing.
5. Price Fixation:
Under the market-based approach adopted in DPCO, 2013, the ceiling price of a
scheduled formulation is determined by first working out the simple average of price to
retailer (PTR) in respect of all branded-generic and generic versions of that particular
formulation having a market share of one percent and above, and then adding a notional
retailer margin of 16 percent to it. The maximum retail price (MRP) for that particular
drug formulation must not exceed the notified ceiling price plus applicable local taxes.
NLEM 2015 contains 929 scheduled drug formulations spread across 30
therapeutic groups, which effectively comes to 814 scheduled drug formulations if we
net those appearing in more than one therapeutic group and formulations in different
pack sizes. NPPA also fixes the ceiling prices of formulations listed under Explanation-I
to Schedule – I of DPCO 2013. NPPA has fixed the ceiling prices of 540 formulations
under DPCO, 2013 as on 15th Nov 2016. For remaining formulations, NPPA is in the
process of fixation of ceiling prices.
The status of fixation of ceiling prices under DPCO, 2013 (revised Schedule-I
based on NLEM 2015) is given as under:
Pricing status of scheduled formulations as on 15th November 2016
Particulars NLEM NLEM Total NLEM Grand
2015 2015 Explanation I Total
(New) (Common) to Schedule-I
1 2 3 4 (2+3) 5 6 (4+5)
A. Entries in the Schedule 380 434 814 814
86 A1 Additional count for the 39 39 39
packsizes/material
B. Ceiling Prices 254 244 498 42 540
Notified/approved
Statement showing range of reduction in ceiling price of scheduled formulation with

respect to the highest price on the basis of data furnished by pharmatrac /
pharmaceutical companies.
% reduction with respect to Maximum Price No. of formulations
0<= 5% 129
5<=10% 74
10<=15% 67
78
15<=20% 68
20<=25% 61
25<=30% 42
30<=35% 33
35<=40% 18
Above 40% 48
Total formulations 540
The prices are notified through Gazette Notifications which are also uploaded on
NPPA's website at www.nppaindia.nic.in. The ceiling prices become operative and
legally enforceable from the date on which the price is notified in the Gazette.
NPPA also capped the maximum retail price of 106 formulations (antidiabetic and
cardiovascular under para 19 of DPCO 2013 in July, 2014.
The fixation of ceiling prices of scheduled formulations listed in NLEM 2015
(revised Schedule-I) has enabled savings of Rs. 2345.50 crore to the consumers.
Fixation of ceiling prices of scheduled formulations under original Schedule-I enabled
savings of 2422.24 crore to the consumers. The para 19 price notifications resulted in
savings of approximately Rs. 350 crore to the consumers. Regulation of prices of
medicines under DPCO 2013 by NPPA has thus resulted in net savings of
approximately Rs. 5203.29 crores to the consumers (as on 14.01.2017).
NPPA has also notified 407 retail prices of ‘new drugs’ [those qualifying as ‘new
drugs’ as per para 2/u) of DPCO, 2013] on request of the manufacturers till 15th
November 2016.
6. Monitoring and Enforcement:
Non-compliance with the notified ceiling price in case of scheduled drug
formulations or, in other words, the MRP breaching ceiling price plus applicable local
taxes tantamounts to overcharging the consumer. Such overcharged amounts are
recovered from the pharmaceutical company along with interest thereon from the date of
overcharging. The overcharging amount thus collected is deposited in the Consolidated
Fund of India. Cases of companies not complying with the demand notices are referred 87
to the District Collectors for recovery of overcharged amounts as arrears of land

revenue. Further, non-compliance of price notification issued by NPPA, depending
upon the gravity of the offence, could also attract prosecution under the Essential
Commodities Act (ECA), 1955.
Para 20 of DPCO, 2013 stipulates that manufacturer can increase the maximum
retail price of a non-scheduled formulation not more than ten percent of maximum retail
price of the preceding twelve months.
79
The notified ceiling price with respect to scheduled formulations is subject to

annual revision as per the annual Wholesale Price Index (WPI) for the preceding
calendar year notified by the Department of Industrial Policy and Promotion (DIPP).
The ceiling prices, thus revised on the basis of WPI are notified by NPPA, to be effective
from the first day of April of the succeeding year. The WPI for the year 2015 was
notified as (-) 2.7105% by the DIPP. The ceiling prices of 530 scheduled formulations
(for which prices were fixed under original Schedule-I NLEM 2011) were accordingly
revised, vide notification dated 2nd March, 2016.
NPPA had also clarified that ceiling prices of scheduled formulations which have
become non-scheduled after adoption of NLEM-2015 as the revised Schedule-I of
DPCO, 2013, will continue to remain under price control till 1st April 2017.
Monitoring and enforcement under the provisions of DPCO, 2013 is the joint
responsibility of NPPA and the State Drug Controllers. NPPA, along with State Drugs
Controllers also undertake market surveillance of prices of scheduled and non-
scheduled formulations under which following activities are done:
x Purchase of samples by NPPA officers from across the country,
x Examination of test samples received from State Drug Controllers,
x Examination of complaints received from individuals / NGOs/VIP
references, etc.
x Analysis of Pharmatrac data
Based on analysis, specific cases are identified for recovery of overcharged
amounts; and fixation of prices, wherever required.
NPPA also monitors the availability of essential formulations and identifies
shortages, if any, and takes remedial steps.
Monitoring and Enforcement activities from 2010-11 to 2015-16 (upto October,
2016) are given as under:
88 Year No. of Prima Facie Referred for
Samples Violations Overcharging
Collected detected
2010-2011 553 225 216
2011-2012 559 156 152
2012-2013 626 165 163
2013-2014 993 389 389
2014-2015 3898 # 1020 1020
2015-2016 2947 # 613 613
2016-2017 1426 #* 279 279
*including 503 cases under process on 31.10.2016
#Cases of Overcharging referred from State Drug Controllers are included under the
column ‘Samples Collected’.
80
7. New Initiative:
‘Pharma Sahi Daam’ an android version of Mobile App was developed by NPPA
and launched officially by Hon’ble Minister (Chemicals & Fertilizers/Parliamentary
Affairs) on 29th August, 2016 on the occasion of NPPA Foundation Day to provide
information to consumers on prices of scheduled medicines which are under price
regulation as well as prices of non-scheduled medicines. This app helps consumers to
check the ceiling prices of medicines and to verify whether medicines are being sold
within the approved price range and also to detect any case of overpricing by
pharmaceutical company/chemist. In case of overpricing the consumer can lodge a
complaint through Pharma Jan Samadhan website.
(http://nppaindia.nic.in/redressal.html).
8. e- Initiatives:
(a) Pharma Jan Samadhan (PJS), a web enabled system was developed by the
NPPA with the assistance of National Informatics Centre (NIC). It was launched on 12th
March 2015. It serves as a robust e-governance tool for protection of consumer interest
through effective implementation of the DPCO, 2013. The primary objective of PJS is to
put in place a speedy and effective complaint redressal system with respect to
availability of medicines, overpricing of medicines, sale of ‘new drugs’ without prior price
approval and refusal of supply or sale of medicines without good and sufficient reasons.
Any individual or consumer organization or stockiest / distributor / dealer / retailer or
State Drugs Controller can lodge a complaint online through the PJS portal. Action on
the complaint received through PJS with complete information is initiated within 48
hours by the NPPA.
(b) Pharma Data Bank (PDB) - Integrated Pharmaceutical Database Management

System (IPDMS): Launched on 25th June, 2015, IPDMS was developed by the NPPA in
collaboration with the National Informatics Centre (NIC). This comprehensive online 89
system provides a platform to the pharmaceutical manufacturer/ marketing/ importer/
distributor companies to file mandatory returns prescribed in Form II, Form III and Form
V of DPCO, 2013. Application for price approval of ‘new drug’ in Form-I can also be filed
through this portal. Online submission of application under Form IV will be made
available shortly. 689 pharma companies have registered under IPDMS till 30th October,
2016 Information regarding 61646 products has been registered by pharma companies.
PDB is expected to benefit industry, consumer and the regulator. It provides industry
with a user friendly mechanism to comply with the mandatory requirement of filing
81
returns; NPPA would be able to fix prices on the basis of price disclosure by companies
and remove its dependency on private databases; and the consumer will be able to
access price data with respect to each scheduled / non-scheduled formulation and take
informed decision on cost-effective treatment. Retailers will also have access to real
time price data. It will also help NPPA to monitor price compliance.
9. Plan Scheme of Consumer Awareness and setting up of Price Monitoring and
Resource Units (PMRUs):
NPPA is implementing a plan Scheme of ‘Consumer Awareness, Publicity and
Price Monitoring’. The Scheme creates general awareness about the availability of
medicines, prices of medicines, ceiling prices of medicines fixed by the Government,
precaution to be taken while purchasing medicines and about the functioning of NPPA.
This helps to improve the accessibility of quality medicines at a reasonable price to the
common people of the country.
The revised/modified scheme has two parts: - National Level Component and
State/UT level Component. Under National level component, consumer awareness is
created through print and electronic media through advertisements, radio jingles etc.
The scheme also envisages conducting Research Studies on Availability of Essential
Medicines, pharmaceuticals pricing and related issues, organizing consumer awareness
workshops and purchase of test samples for price monitoring purpose. Under the
State/UT level component grants-in-aid are given to States for setting up Price
Monitoring and Resource Units (PMRUs) and purchase of test samples by the State
Drugs Controller and their Field Offices.
NPPA initiated action for setting up of Price Monitoring and Resource Units
(PMRUs) in States/Union Territories under the Scheme to provide necessary support to
the State Drug Controllers to discharge the monitoring and enforcement activities
mandated under the DPCO, 2013. Each Unit will function under direct supervision of the
90 concerned State Drugs Controller. PMRUs will be the key collaborating partners of
NPPA for information gathering and to ensure that the benefits of DPCO, 2013 trickle
down to the grassroots level. The Scheme initially at the pilot stage is being
implemented for a period of two years in seven states viz., Assam, Gujarat, Haryana,
Kerala, Maharashtra, Manipur and Odisha.
10. Outreach activities:
NPPA organized a series of workshops / seminars at various places to help
disseminate information about the implementation of DPCO, 2013 and on issues of
availability, affordability, and accessibility of medicines. These workshops were
82
organized at Bangalore in collaboration with National Law School of India University in

January 2016 and at NIPER Mohali in November 2016 (in collaboration with state
governments of Punjab, Haryana, Himachal Pradesh & UT Admn. of Chandigarh). More
such seminars are scheduled in 2016-17 as part of NPPA’s outreach activities. These
workshops brought many experts from the pharmaceutical sector, academicians, health
experts, civil society activists, industry representatives and government officers who
gave their perspectives on pharmaceutical pricing, patenting of medicines, innovations
in the pharmaceutical sector and national and international best practices on the
subject.
11. NPPA Foundation Day
The Foundation Day of NPPA was celebrated on 29th August, 2016 at Vigyan
Bhawan, New Delhi in the gracious presence of Hon’ble Minister for Chemicals &
Fertilizers and Parliamentary Affairs. On the occasion, a one-day National Seminar on
“Affordable Medicines” was organized. The seminar discussed subjects related to
overall drug ecosystem. Eminent speakers from different stakeholder groups,
academia, lawyers, civil society activists, industry representatives and senior
government officers made presentations on different subjects related to the
pharmaceutical sector.
In order to promote the concept of affordable medicines, and to recognize the
efforts of Department of Pharmaceuticals towards ensuring affordability, availability and
accessibility of medicines, Hon’ble Minister for Chemicals & Fertilizers and
Parliamentary Affairs, on the request of NPPA, announced that August 29 would be
commemorated as ‘Rashtriya Jan Aushadhi Diwas’. The proposal of the NPPA is under
active consideration.
12. NPPA Logo
NPPA Logo was unveiled by the Hon’ble Minister (Chemicals & Fertilizers and
Parliamentary Affairs) on the occasion of NPPA Foundation Day Celebrations on 29th 91
August, 2016. The logo was selected after screening entries received through cloud-
sourcing.
83
13. Recovery of overcharged amount:
Action for recovery of the overcharged amount along with interest thereon is a
continuous process. NPPA takes action as per the provision of DPCO 1995/ DPCO
2013 read with relevant provisions of the Essential Commodities Act, 1955.
NPPA has initiated about 1467 cases of overcharging as on 31st October 2016
(1283 cases under DPCO 1995 and 184 cases under DPCO 2013), where demand
notices have been issued to pharmaceuticals companies. The demanded amount works
out to Rs. 4958.74 crore (4877.74 crore under DPCO 1995 and 81.00 crore under
DPCO 2013) for sale of medicine at prices higher than that fixed by NPPA /Government.
However only an amount of Rs. 598.80 crore (Rs 536.81 crore under DPCO 1995 and
Rs. 61.99 crore under DPCO 2013) has been recovered on 31st October, 2016, from
pharmaceutical companies. This includes an amount of Rs. 214 crore deposited by
pharmaceutical companies in response to the verdict of the Supreme Court delivered on
20th July, 2016 in 109-111/2013, 153-164/2013, WC(C) 696/2013, WP(C) 983/2013,
WP(C) 123/2014, WP(C) 135/2014 and WP(C) 346/2014. Out of the balance
outstanding amount of Rs. 4359.93 crore, Rs. 3460.32 crore is still locked up in
litigation.
The recent pronouncements of the Supreme Court and Bombay High Court in
certain cases of overcharging have upheld the notifications issued by NPPA in
regulation of ceiling prices of scheduled formulations and capping of MRP of certain
non-scheduled formulations. The Hon’ble Supreme Court its judgment dated 21st
October, 2016 in CA No. 329/2005-UOI vs Cipla, CA No 4005/2004, CA No. 9609-
9610/2016, CA No. 9585/2016, CA No. 9586/2016 and CA No. 9561-9584/2016 has
given legal approval to the norms and notifications issued by NPPA from 1995 to 2003
under DPCO 1995. Pharmaceutical companies in compliance with this judgment have
started depositing the overcharged dues with government.
92
The Hon’ble High Court of Bombay on 26th September, 2016 dismissed WP
2700/2014 filed by India Pharmaceutical Alliance upholding price notifications issued by
NPPA in respect of 106 antidiabetic and cardiovascular formulations on 10th July, 2014
under para 19 of DPCO, 2013. The SLP filed by IPA in the Supreme Court against the
said judgement of the Bombay High Court was dismissed on 24th October, 2016. The
judicial verdicts have sent a strong signal recognizing the requirement of regulation of
prices of essential medicines in order to ensure affordable, available and accessible
healthcare for all.
84
Chapter
8
IMPLEMENTATION OF RAJBHASHA
CHAPTER
CHAPTER 8
8
IMPLEMENTION OF RAJBHASHA
8.1 IMPLEMENTION OF RAJBHASHA
Use of Hindi in official work
Every possible effort was made for implementation of the various provisions of the Official
Language Policy of the Union of India including those of Official Languages Act, 1963 as well
as Official Languages (Use for Official Purposes of the Union) Rules, 1976 and orders issued
thereunder. All the documents mentioned in Sub Section (3) of Section 3 of the Official
Languages Act, 1963 were issued bilingually i.e. in Hindi as well as in English. Letters received
in Hindi and representations etc. signed in Hindi were replied to in Hindi as per provisions of
the Rule 5 and Rule 7(2) of the Official Languages (Use for Official Purposes of the Union)
Rules, 1976 (as amended in 1987).
Hindi Prayog Protsahan Pakhwara, 2016

Hindi Prayog Protsahan Pakhwara was observed in the Department from 14th to 28th
September, 2016 with the objective to encourage the officers and employees of the
Department to progressively increase the use of Hindi in their official work and also to help the
Department to create an atmosphere conducive to use of Hindi.
In addition to the message issued by the Secretary (Pharma) requesting, inter-alia, all the
officers/employees to make a commitment to use of Hindi, various Hindi competitions were
held during the Pakhwara in which officers/officials participated in unprecedented numbers and
made this programme successful. Winners were awarded with cash prizes and Commendation
Certificates.
Review of the status of use of Hindi in the offices under the Department
Periodical review of the use of Hindi in the offices under the Department was made through the
quarterly reports on progressive use of Hindi received from them in compliance with the targets
95
set in the Annual Programme for use of Hindi for the year 2016-17,
86
Chapter
9
GENERAL ADMINISTRATION
9.1 Organizational Set Up
CHAPTER
CHAPTER 9 – 9
9.1 ORGANISATIONAL SET UP OF THE DEPARTMENT
The main activities of the Department are policy making, sectorial planning
promotion and Development of Pharmaceutical industries including medical devices.
The administrative and managerial control of the public sector undertakings engaged in
the manufacture of various, pharmaceutical items and some other organization is a
major function of the Department.
2. The Department is headed by Secretary to the Government of India who is
assisted by two Joint Secretaries.
3. There is an attached office namely “National Pharmaceutical Pricing Authority”
which looks after Price fixation/revision of pharmaceuticals and other related matters. It
also monitors the prices of decontrolled drugs and formulation and oversees the
implementation of the provisions of the Drug (Price Control) Order.
EMPLOYMENT OF SCHEDULED CASTES / SCHEDULED TRIBES / PHYSICALLY
HANDICAPPED IN THE MAIN SCERETARIAT OF THE DEPARTMENT OF
PHARMACEUTICALS
The status of employment of Scheduled Castes / Scheduled Tribes / Other
Backward Classes / Physically handicapped in the main Secretariat of the Department
of Pharmaceuticals, as on 31.12.2016 is as under:-
Group Total No. In Scheduled Scheduled Other Physically
Of Posts position Castes Tribes Backward Handicapped
Classes
A 30 17 4 1 - -
B 48 31 5 3 7 -
C 25 22 7 - 5 -
Total 103 70 16 4 12 -
4. Officers in Group A include officers belonging to Central Secretariat Service 99

besides officers on deputation from All India Services, Central Services and other
Departments/ Undertakings. Appointment to posts in Group B and C is mostly done on
the basis of nominations made by the Department of Personnel & Training.
5. The Department also monitors the progress of filling up of the posts reserved for
the members of Scheduled Castes, Scheduled Tribes and other Backward Classes in
the Public Sector Undertaking under the administration control of the Department.
88
100
Sh. Jai P
Priye Prakash,
Seecretary
Sh. Su
udhansh Pant Sh. Raajneesh Tingal
JS Smt. Meenaksh
hi Gupta Econom
mic Advisor
JS
(Admn.,Vig., Estt., Pricing, (C
CPSE, Raj AS & FA
A Vaacant
PMJAYY, PI-NORMS) Bhasha, CCoordination, IT,
Parlia
ament, NIPER
Sh. Devendra Kumar
DS
(PSU)
Sh. M. K Bhardwwaj Sh. A
A.K. Chaudhary
Sh. A. K. Chaudharyy Sh. Jiten
ndra Trivedi
DS Director Director Dirrector Joint Director
(Admin, Establishm
ment, (Policy Matters, Ind.
Vigilance) (
(Parliament, Coordinattion, (Raj Bhashaa, NIPER, R&D, (Cost)
sues, Pricing,
Iss IT & Media)
Medica al Device) V
Vacamt
PMJAY)
S
Sh. S. K. Jha Sh
hri A.V. Lakra
US Sh. Raj Kumar Sh. Parve
een DS
(Admin, US Kumarr
(Industry Issues, Int. Sh. Anil Jain (IFD)
Establishment, Cooperation, US
US
Vigilance) Pharma Ind., evice)
(Medical De
PMJAY) (PSU)
Sm
mt. Barnali US
K
Khastgir Sh. Satish Kumar
(IFD)
US US
Vacant
( Pricing, (NIPER, R&D)
PII-NORMS)
Sh. H. K. Mallick
US
(Parliament, Coori
dnation, IT &
Media)
89
Chapter
10
CITIZEN CENTRIC GOVERNANCE
10.1 Our Vision
10.2 Our Mission
10.3 Our Clients
10.4 Our Commitment
10.5 Our Services
10.6 Our Activities
10.7 RTI-2005
10.8 CPGRAMS
CHAPTER – 10
CHAPTER 10
10.1 Our Vision:
Based on the mandate given to the Department of Pharmaceuticals through the
allocated functions a vision has been fixed in concurrence with the Cabinet Secretariat,
which is as follows:
“India: The largest global provider of quality medicines at reasonable
prices.”
10.2 Our Mission:
1. Ensure availability of quality drugs at reasonable prices as per the Pharma
Policy.
2. Development of Pharma Infrastructure and Innovative Development in
Pharma Sector including through PPP.
3. Promote Pharma Brand India.
4 Encourage environmentally sustainable development of Pharmaceutical
Industry.
5. To establish NIPERs as nationally and internationally recognized brand in the
field of education and research of pharmaceutical sciences for the benefit of
human kind.
10.3 Our Clients
x Citizens of India
x Pharmaceuticals and Medical Device Industry including Small and Medium
Enterprises
x Pharmaceuticals companies seeking relief under DPCOs
x NPPA/ CPSUs/NIPERs
10.4 Our Commitment 103
We are committed to provide impartial, sympathetic and prompt services to the public in
matters relating to the pharmaceuticals industries.
Our commitment is to take prompt steps to provide quick redressal of the grievances of
our personnel and public at large.
Our commitment is to formulate policies and initiate consulations with all Industry
Associations/stakeholders and to amend them whenever so required.
91
10.5 Our Services

We formulate and implement policies relating to drugs and pharmaceuticals,
dyestuff and dye intermediates.
10.6 Our Activities
The key activities of the Department focus on:
1. Ensure availability of drugs at reasonable prices as per provisions of the
Drug Prices Control Order 2013
2. Ensure proper functioning of the Central Pharma Undertakings in control
of the Department.
3. Project Based Support and Revival Schemes for CPSUs
4. Ensure proper management of M Pharma and Ph.D. programs in NIPERs
5. Develop Human Resources, Infrastructure for Pharma R&D and Industry
including Public-Private-Partnerships (PPP)
6. Formulate Scheme/ Project for promoting Pharma Brand India
7. Formulate Scheme/ Project for promoting environmentally sustainable
development of Pharmaceutical Industry
8. Formulation of Annual Plan, Budget and Monitoring of Budget
Expenditure
The Citizen Charter of the Department has been placed on the website of the
Department.
10.7 Right to Information Act 2005

As per the provisions of the RTI Act 2005, all the relevant information relating to
Department of Pharmaceuticals has been available on the web site in a manner, which
is easily accessible and comprehensible to the public.
104 Central Public Information Officers and Appellate Authorities have been nominated in
the department to provide information to the public.
10.8 CPGRAMS (Centralized Public Grievances Redress And Monitoring System)

Public Grievances received offline and through CPGRAMS are monitored and
disposed off regularly.
92
Chapter
11
INFORMATION AND COMMUNICATION TECHNOLOGY
Chapter – 11
CHAPTER 11
INFORMATION AND COMMUNICATION TECHNOLOGY
Information and Communication Technology
Under Digital India program, Department of Pharmaceuticals has taken sincere
initiatives towards adoption of E-Governance to deliver information and services online.
This had led to benefits in terms of transparency, easy accessibility of services,
improvement of internal processes and decision support system.
An IT based Computer Centre, set up by National Informatics Centre (NIC) is
operational in the Department and is equipped with latest Servers and Client machines
for providing various IT related services to the Department. NIC is delivering valuable
key services like Technical consultancy, Networking, application development and
implementation, Internet & E-Mail , database management and Training. With NIC’s
presence and expertise, Department had been instrumental in steering following IT/E-
governance initiatives.
Local Area Network (LAN):
All work places in the department are connected on Local Area Network (LAN) which is
upgraded to make it IPv6 compliant is managed by the National Informatics Centre
(NIC) to provide round the clock facilities for E-mail, intranet / internet and database
access operations. The IPv6 compliant ICT hardware is available to all officers/
divisions/ sections for the use at their desktop.
Website and Social Media
A vibrant revamped Bilingual Web Site of the Department, ie
http://pharmaceuticals.gov.in was launched by the then Hon’ble Minister of State Shri
Hansraj Gangaram Ahir in September’ 2015 and is hosted at NIC cloud to ensure
security and maximum reach of information to the citizens. The website is developed by
NIC using content management framework and is GIGW compliant. It provides details of
organizational set up of the department, its functions, subordinate offices, policies, 107
publications, statistical data/information on functional parameters.
Website for Jan Aushadhi Scheme of the Department http://janaushadhi.gov.in)
provides details of the scheme, list of generic medicines (unbranded) which are being
dispensed through the Jan Aushadhi Stores (JAS) being setup in various districts of
India. Website is revamped to facilitate the visitors to know the locations of the JAS
already opened. It also provides comparative prices of Generic Medicines sold at Jan
Aushadhi Stores and Branded Products.
94
Social media had enormous potential to reach people. To improve the quality of
Government decision, policy making and create awareness, Dept. has created
Facebook and Twitter accounts. Information regarding the conferences, Seminars,
launches by Minister, MOS, Secretary and other officers of Dept. is posted on it
promptly. Various posts to create awareness regarding generic medicines, Educational
and Research institutes NIPERs, etc. also is posted on Facebook and twitter pages of
Department.
Video Conferencing:
Video Conferencing facility is operational for Secretary. PSUs and Educational
Institutes (NIPERs) have also installed the Video Conferencing facility. VC facility
enables Department to interact with PSUs and NIPER frequently to monitor their
performance and communicate the decisions. Pragati, Monitoring tool of PM office is
conducted every month and Hon’ble PM interacts with all Secretaries and State CS to
address issues which are long pending through Video Conferencing. Video
Conferencing facility is also utilized for interacting with foreign delegates.
Work Flow Automation
Another initiative taken by Department towards Digital India is to implement
automation of work flow inside the Department. e-Office is a standard product presently
consists of e-File, e-Leave, e-Tour, Knowledge Management System (KMS), Personnel
Information Management System (PIMS), Collaboration & Messaging Service (CAMS)
and is aimed at increasing the usage of work flow and rule based file routing, quick
search and retrieval of files and office orders, digital signatures for authentication, forms
and reporting components. e-Office is being implemented to reduce duplicity of work,
increases transparency and efficiency.
E-Governance:
Taking advantage of latest ICT enabled tools, Department of Pharmaceuticals with
108
the support of NIC has taken sincere initiatives towards adoption of best practices.
Various applications have been developed and implemented by NIC to strengthen,
monitor and decision making and high availability of right information at right time.
x Aadhaar enabled Biometrics Attendance System (AEBAS) - Biometrics

Attendance System records attendance of all employees (Permanent and
Casual) of Department. Dept. of Pharmaceuticals has implemented AEBAS in the
first phase and 17 finger reader devices are installed at offices of JS & above
95
level officers and at all sections. Tablet devices are also installed at all gates of
Bhawans to facilitate officials/staff to mark the attendance.119 employees are
registered and are marking the attendance regularly. Monthly register is
generated for monitoring of attendance.
x SPARROW- Smart Performance Appraisal Report Recording online Window
(SPARROW) application which allows online submission of APAR and
processing of IAS officers is implemented successfully.
x Parliament Questions and Assurances System – Repository of Parliament
Questions and reminder system of Assurances is developed to facilitate Officials
to keep record of all answered question and pending assurances.
x Visitor Management System - eVisitor System is a web based solution for Visitor
Management. This facilitates citizens for online registration of requests for their
visit and approval is given to authenticated visitors and gate pass is issued.
x Court Cases Monitoring System – This system is repository of all court cases of
Department. It also keeps the track of forthcoming hearing dates of Cases and
basic details of the case. It facilitates officials to generate useful reports.
x Online RTI-MIS – To dispose of and monitor RTI applications efficiently, Dept.
has taken initiative to use Online RTI-MIS. Necessary training was imparted to
concerned officials/staff to implement RTI-MIS successfully.
x CompDDO- CompDDO package implemented for processing salary of
officials was upgraded to version 4.0 with additional features. This enables
salary distribution through E-payment.
x Centralized Public Grievance Redress Monitoring System (CPGRAMS):
CPGRAMS is implemented in the Department and all the attached office to
address Public grievances received online with minimum delay.
x E-publishing of Tenders – E-publishing of tenders is implemented by uploading 109
tenders on Central Public Procurement Portal. It has improved the accessibility of
tenders.
x Other e-Governance applications like RTI Request & Appeal Management
Information System, e-Samiksha, Pragati and Foreign Visit Management System
are functional in the Department to facilitate various sections.
96
To enhance e-Governance further following initiatives has been taken up.

x PSEs Performance Monitoring System- Performance of Public Sector Enterprises
is to be monitored by Department and for the purpose; a web based application is
under development to ensure monitoring and facilitate the top level officers in
decisions making.
x Store Inventory System – Store Inventory System is being customised for
implementation in the department. It will facilitate online issuance of items to
employees and keep records of store and inventory.
Training:
NIC Computer Cell organises User Training for operational know how and awareness
program to keep user well aware of use of latest IT technologies. Under Digital India
Program, above said applications were implemented and training was imparted as when
required. Training on e-Office is being imparted to all officers/staff (including JS level
officials) of the department. All employees (including outsourced) were sensitized about
operations of Aadhaar enabled Biometrics Attendance System (AEBAS). Concerned
sections were trained on e-Samiksha, CPGRAMS, CompDDO, E-publishing, Court
Cases Monitoring System. Training on Sparrow Software is imparted to all IAS officials.
E-office:
As per direction issued, E-office is being fully implemented in the department. Training
has been imparted to all the employees including outsourced staff of the Department.
Digital Signature has been provided to all the employees of the department upto the
level of the office of MoS. E-office has become operational from 1st November, 2016.
Target for 100 % implementation of E-office is set for 31-03-2017. As on date, above
90% work of the department is being done through E-office.
110
97
Chapter
12
ANNEXURE
Annexure – I [A] (List of PSUs and Other Organizations)
Annexure – I [B] (Address and Name of various Organizations& PSUs
Annexure – I [C] (List of Responsibility Centers and Subordinate Organizations)
Annexure – II (Organizational Chart of NPPA)
Chapter –12
Chapter 12
ANNEXURE 1 [A]
ANNEXURE 1 [A]
List of Public Sector Undertakings
1 Indian Drugs & Pharmaceuticals Ltd, Dundahera Industrial Complex,
Dundahera, Gurgaon, Haryana.
2 Hindustan Antibiotics Ltd, Pimpri, Pune, Maharahstra.
3 Karnataka Antibiotics & Pharmaceuticals Limited, Bangalore-560010.
4 Bengal Chemicals & Pharmaceuticals Ltd, Kolkata, West Bengal.
5 Rajasthan Drugs and Pharmaceuticals Limited. Road NO.12, V.K.I. Area,
Jaipur-302013.
OTHER ORGANISATIONS
1. Bengal Immunity Limited, Kolkata, West Bengal.
2. Smith Stanistreet Pharmaceuticals Ltd. Kolkata, West Bengal.
ANNEXURE 1 [B]
Address and Names of Head of various Organization & PSUs under the Department of
Pharmaceuticals
Sl. No. Address and Organization Name Designation
1. Indian Drugs & Pharmaceuticals Shri Sudhansh Pant Chairperson & Managing
Limited (IDPL), Gurgaon Director
2. Hindustan Antibiotics Limited (HAL), Ms. Nirja Saraf Managing Director
Pune-411010
3. Karnataka Antibiotics & Shri K. M. Prasad Managing Director
Pharmaceuticals Limited (KALP),
Banglore-700013
4. Bengal Chemicals & Pharmaceuticals Shri P.M. Chandraiah Managing Director
Limited (BCPL), Kolkata-700013
5. Rajasthan Drugs & Pharmaceuticals Shri S.B.Bhadrannavar Managing Director
Limited (RDPL), Road No. 12 V.K.I 113
Area Jaipur-302013
99
OTHER ORGANISATIONS
1. Bengal Immunity Limited, Kolkata, West Bengal.
2. Smith Stanistreet Pharmaceuticals Ltd. Kolkata, West Bengal.
ANNEXURE 1 [B]
ANNEXURE 1 [B]
Address and Names of Head of various Organization & PSUs under the Department of
Pharmaceuticals
Sl. No. Address and Organization Name Designation
1. Indian Drugs & Pharmaceuticals Shri Sudhansh Pant Chairperson & Managing
Limited (IDPL), Gurgaon Director
2. Hindustan Antibiotics Limited (HAL), Ms. Nirja Saraf Managing Director
Pune-411010
3. Karnataka Antibiotics & Shri K. M. Prasad Managing Director
Pharmaceuticals Limited (KALP),
Banglore-700013
4. Bengal Chemicals & Pharmaceuticals Shri P.M. Chandraiah Managing Director
Limited (BCPL), Kolkata-700013
5. Rajasthan Drugs & Pharmaceuticals Shri S.B.Bhadrannavar Managing Director
Limited (RDPL), Road No. 12 V.K.I
Area Jaipur-302013
99
114
ANNEXURE 1 [C]
ANNEXURE 1 [C]
List of Responsibility Centers and Subordinate Organizations:
(NIPERs)
S. Responsibility Address
no. Centers and
Subordinate
1 NIPPER, MOHALI SAS Nagar, NIPER Mohali,
Dr. P.J.P. Singh Punjab - 160062
(Registrar)
Officiating Director is
yet to be appointed.
2 NIPER, AHMEDABAD Palaj Opp. Air Force Station Head Quarter, Gandhinagar-
Dr. Kiran Kalia, 382355, Gujarat
(Director)
3 NIPER, HYDERABAD IDPL Township, Balangar, Hyderabad-500007
Dr. S. Chandrasekhar
(Project Director)
4 NIPER, HAJIPUR E.P.I.P. Campus, Industrial Area, Hajipur-844102, Bihar

Dr. Pradeep Das,
(Project Director)
5 NIPER KOLKATA Indian Institute of Chemical Biology (IICB, under CSIR),
Dr. V. Ravichandiran Mentor Institute for NIPER, Kolkata
(Director) 4, Raja S.C. Mullick Road,
Jadavpur, Kolkata-700032 (West Bangal)
6 NIPER GUWAHATI
Dr. USN Murty 3rd Floor, Department of Pharmacology, Guwahati Medical
(Director) College & Hospital
Guwahati-781032, Assam
7 NIPER RAEBARELI NIPER Raebareli, Shree Bhawani Paper Mill Road, ITI
Dr. SJS Flora compound, Raebareli U.P. (India) - 229010
(Director)
115
100
Annexure – II
Organisational Chart of NPPA
116

Chemical Pharma Report 2019

Uploaded by

Copyright:

Available Formats

Chemical Pharma Report 2019

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Chemical Pharma Report 2019

Uploaded by

Copyright:

Available Formats

2016-17

2. AN OVERVIEW OF PHARMACEUTICALS INDUSTRY

3. OVERVIEW OF MEDICAL DEVICES INDUSTRY

4. PRADHAN MANTRI BHARTIYA JANAUSHADHI PRARIYOJAN (PMBJP)

5. NATIONAL INSTITUTES OF PHARMACEUTICALS EDUCATION & RESEARCH (NIPERs)

6. PUBLIC SECTOR UNDERTAKINGS

7. NATIONAL PHARMACEUTICALS PRICING AUTHORITY

10. CITIZEN CENTRIC GOVERNANCE

11. INFORMATION AND COMMUNICATION TECHNOLOGY

3. AN OVERVIEW OF MEDICAL DEVICE INDUSTRY 21

4. Pradhan Mantri Bhartiya Janaushadhi Pariyojana. 31

5. National Institutes of Pharmaceutical Education & Research (NIPERs) 39

6. PUBLIC SECTOR UNDERTAKINGS 63

7. NATIONAL PHARMACEUTICAL PRICING AUTHORITY (NPPA) 85

10. CITIZEN CENTRIC GOVERNANCE 103

11. INFORMATION AND COMMUNICATION TECHNOLOGY 107

12. ANNEXURES 113

Financial Performance of the Drugs & pharmaceuticals industry. Pharma exports

Income & Expenditure Summary : Drugs & Pharmaceuticals Industry

Rs. Million: 2010-11 to 2015-16 5

Income & Expenditure Summary: Drugs & Pharmaceuticals Industry

Performance of Pharma Imports: - During April-November 2016, drug imports

Subsequently, to implement the NPPP-2012, the new Drugs (Prices Control)

With a vision to catalyze and encourage quality, productivity and innovation in

x Effluent Treatment Plant

The objectives of this scheme are as under:-

(i) Increasing the competitiveness, easy access to standard testing and

Department of Expenditure’s in-principle approval has been received for

2.6 Ease of Doing Business

1. EU-India Joint Working Group on Pharmaceuticals, Biotechnology and Medical

2.8 Pharmaceuticals Promotion Development Scheme (PPDS):

i) Conduct Training/knowledge improvement programs/activities on issues/subjects

Events organized/to be organized under Pharmaceuticals Promotion

1 Conference on “APIs: Reducing dependence on Imports” on 28 July 2016 at

2 Seminar on “Bio-Pharma: Biosimilars & Biogeneric; Emerging Investment

14 Seminar/Workshop on “Awareness on Jan Aushadhi Scheme” at Bhopal on 30

The Department of Pharmaceuticals provided financial assistances for the

S. No. Financial assistances

2 Financial assistance to Associated Chambers of Commerce & Industry of India

3 Financial assistance to National Institute of Pharmaceutical Education and

10 Financial assistance to Indian Drug Manufacturers' Association (IDMA) for

28 Financial assistance to Directorate of Advertising and Visual Publicity (DAVP) for

2.9 India Pharma 2017 and India Medical Device 2017

2.10 India Pharma Awards

Sl. No. CAT No. Category of Award Name of the Company

3.1 Indian Medical Device Industry:

Medical device industry is a multi-product industry, producing wide range of

Figure: Global Medical Device Market Size

Figure: Medical Device Market Size- India

3.4 Medical Device Segments – India

Figure: Growth Factors Driving the Medical Device Demand in India

3.5 Medical Device Rules, 2016

v. There will be no requirement of periodic renewal of licences. Accordingly,

3.6.2. Corrections in the Inverted Duty Structure:

3.6.3. Medical Device Promotion Council:

3.6.4. Preferential Market Access:

3.6.5. Uniform Code For Medical Device Marketing Practices (UCMDMP):

Progress achieved during 2016-17 as on 16th February, 2016:

MoUs signed with Different State Governments for opening PMBJK: