UNIT -2-TECHNOLOGY

DEVELOPMENT& TRANSFER
POINTS TO BE COVERED IN THIS TOPIC

WHO GUIDELINES FOR

FOR TECHNOLOGY
TRANSFER (TT)
Terminology
* Technology Transfer Protocol
QUALITY RISK MANAGEMENT

TRANSFER FROM R & D TO PRODUCTION

(PROCESS, PACKAGING AND CLEANING)
GRANULARITY OF TT PROCESS
(API,
EXCIPIENTS, FINISHED PRODUCTS,PACAGING
MATERIALS)
DOCUMENTATION

PREMISES AND EQUIPMENTS

QUALIFICATION AND VALIDATION

QUALITY CONTROL : ANALYTICAL METHOD
TRANSFER

APPROVED REGULATORY BODIES AND

AGENCIES
 UNIT -2- TECHNOLOGY
DEVELOPMENT& TRANSFER
POINTS TO BECOVERED INTHIS TOPIC
COMMERCIALIZATION- PRACTICAL ASPECTS
AND PROBLEMS

TT AGENCIES IN INDIA -APCTD, NRDC, TIFAC,

BCIL, TBSE/SIDBI
TT RELATED DOCUMENTATION
CONFIDENTIALITY AGREEMENT, LICENSING,
MoUs, LEGAL ISSUES.
INTRODUCTION
The present market condition is defined as "A age of competition in terms
of quality and low price of products."
In order to sustain in market companies are more aggressively
formulating their policies on research and development and market
competitiveness.
In this process, Various events like merger, consolidation, splitting of
business etc. are taking place.
Therefore, companies either go for in house R&Dor purchase Technology
form others inside the country or from abroad.
Pharmaindustry is characterized with wide range of innovative products
with changing demand.
So, The standard protocol for Transfer to Technology from Research to
Industry needed.
WHOGUIDELINES FOR TECHNOLOGY TRANSFER (TT)
The World Health Organization (WHO) is a
specialized agency of the United Nations looking
after issues of international public health.
It was established on 7 April 1948. Its headquarter
is in Geneva Switzerland.
The WHOis a member of the United Nations development group. Ti::
draught text was subsequently prepared by Mr. John startup Un:
Kingdom and by Dr. Monika Zweygarth South Africa.
The document was then discussed during the consultation
guidelines for medicine, quality assurance quality control laboratories
transfer of Technologyon 27-31 July 2009 and a revision prepared.
The WHO Expert Committee on Specifications for Pharmaceut.
Preparation, therefore, recommended in its 42nd report that }0
address this issuethrough preparation of WHO guidelinesin this are.a.
TERMINOLOGY
Acceptance criteria: Measurable terms under which a test result will be
considered acceptable.
Bracketing: An experimental design to taste only the extreme of, for
example dosage strength. The design assume that the extremes willbe
representative of all the samples between the extremes.
Change control (Cc): A formal system by which qualified
representatives of appropriate disciplines review proposed or actual
changes that might affect a validated status. The intent is to determine the
need for action that would ensure that the system is maintained in a
validated state.
Critical: Having the potential to impact to product quality or
performance in a significant way.
Critical controlpoint (CCP): Astep at which control can be applied
isessential to prevent or eliminate a pharmaceutical quality hazard or
reduced it to an acceptable level.
Corrective action: Any action to be taken when the results of monitoring
a criticalcontrol point indicate a loss of control.
Quality risk management (QRM): It is a systematic process for t
assessmnent, control, communication and review of risk to the quali
of the pharmaceutical product across the product life cycle.
Inter company transfer: Transfer of technology between sites.
different companies.
Intra company transfer: Transfer of Technology between sites of
same group of companies.
Inter site transfer: Transfer of Technology between sites of same
company.
In process control (IPC): Checks Preformed during production in or
to monitor and if necessary to adjust to the process to ensure that
product confirms to its specifications for a stop the control of
environment or equipment may also be regarded as a part of in pro
control.
 Qualification: Action of proving and documenting that any premises,
system and equipment's are properly installed and/or working correctly
and lead to the expected results.
InstallationQualification (1Q):The performance of teststo ensure that
the installation such as machines measuring devices utilities and
manufacturing areas used in manufacturing process appropriately
selected and correctly installed and operate in accordance with
established specifications.
Operational Qualification (0Q): Documented verification that the
tem or subsystem performs as intended overall anticipated operating
ranges.
Performance Qualification (PQ): Documented verification that the
equipment or systenm operates consistently and gives reproducibility
within defined specifications and parameters for prolonged periods.
Standard operating procedures (SOP): An authorized written
procedure giving instructions for performing operations not necessarily
specific to a given product or material. For example Operation of
equipment, maintenance and cleaning, validation meaning of premises
and environment control sampling and inspection) certain SOP may be
used to supplement product specific master and batch production
documentation.
Drug Master File (DMF): Detailed information concerning a specific
facility, Process or Product submitted to the Drug Regulatory
Authority, Intended for the incorporation into the application for
marketing authorization.
* TECHNOLOGY TRANSFER PROTOCO
The transfer protocol should list the intended sequential stages of the
transfer:. Theprotocol should include:

1. Objective
2. Scope
3. Key personnel and their responsibilities
4. Objective
5. Scope
6. Key personnel and their responsibilities
7. aparallel comparison of materials, methods and equipment;
8.
the transfer stages with documented evidence that each critical
stage has been
9. satisfactorily accomplished before the next commences;
10. identification of critical control points;

11. experimental design and acceptance criteria for analytical

methods;

12. information on trial production batches, qualification batches and

process validation
13. change control for any process deviations encountered;
14. assessment of end-product;
arrangemnents for keeping retention samples of active ingredients,
intermediates and
15.
finished products, and information on reference substances where
applicable
16. Conclusion, including signed-off approval by project manager.

Financial

Return

Inventlon
Suysuan Ive n tio
TechnologySciosure
n
Transfer
Assessment

8upaew uoold
QUALITY RISK MANAGEMENT

INTRODUCTION
Quality risk management is a systematic process for the assessment
control communication and review of risk to the quality of the
medicinal product across the product life cycle.
Quality risk management activities are usually undertaken by
interdisciplinary teams as quality unit, business development,
engineering, regulatory affairs, production, operations, sales and
marketing, legal, statics and clinical in addition to individuals who are
knowledgeable about the quality risk management process.
Quality risk management is a process that supports science based and
practicaldecisions when integrated into quality system.
BENEFITS OF ORM:
1. Effective quality risk management can facilitate better and more
informed decisions and can provide regulator's with greater
Assuranceof a company's ability to deal with potential risks.
2. In addition quality risk management can facilitate better use of
resources by all parties.
3. Quality risk management should be integrated into existing
applications and documented appropriately.
PRINCIPLES OF QUALITY RISK MANAGEMENT
Two primary principles of quality risk
management are:
The evaluation of the risk to quality
IDENTIFY
should be based on scientific knowledge ANALYZE

and ultimately link tothe protection of the

patient.
RISK
HANAGEMENT

The level of effort, formality cONTROL

ACTION

documentation of the quality risk

management process should be MONITOR

commensuratewith the levelof risk.

 TERMINOLOGY
S.NO TERM DEFINATIONS

1. Harm
Damage to health, including the damage that can
ccur from loss of product quality or availability.
2. Hazard The potential source of harm (1S0/IEC Guide 51).

3.
The ability to discover or determine the existence,
Detectability presence, or fact of a hazard.

Decision Person(s) with the competence and authority to

4.
Maker
make appropriate and timely quality risk
management decisions.

Product
All phases in the life of the product from the initial
5. development through marketing until the product's
Lifecycle discontinuation

The degree to which a set of inherent properties of a

product, system or process fulfillsrequirements (see
6. Quality ICH Q6A definition specifically for "quality" of drug
substance and drug (medicinal) products.)
The sum of all aspects ofa system that implements
7. Quality quality policy and ensures that quality objectives are
System met.

8. Risk The combination oftheprobability of occurrence of

harm and the severity of that harm
9.
Risk Thedecision to accept risk
Acceptance
Risk The estimation of the risk associated with the
10.
Analysis identified hazards.

APPRUYEC
C o NT
RISK
ASSESSMENT
S.NO TERM DEFINATIONS

A systematic process of organizing information

to support a risk decision to be made within a
11. Risk ASsessment risk management process. It consists of the
identification of hazards and the analysis and
evaluation of risks associated with exposure to
those hazards.

Risk The sharing of information about risk and risk

12.
Communication management between the decision maker and
other stakeholders.
Actions implementing risk management
13. Risk Control
decisions.
A measure of the possible consequences of a
14. Severity hazard.

TRANSFER FROM R&

R D TO PRODUCTION (Process,
Packaging and Cleaning)
This is the most Critical and Important part of technology transfer
document. Following Points must be considered while drafting an
agreement
1. It should be established at the outset whether the intention is to perform
single batch manufacture, continuous production or campaigns and
whether the production unit can accommodate the intended
production capacity.
2. Consideration should be given to the level and depth of detail to be
transferred to support Production and any further development or
process optimization at the production unit as intended under the
transfer Project plan.
3. Consideration should be given to the technical expertise, site
technology and site capabilities. For the production unit. R&D unit
hould identify all the process issue and make it operational at the
production unit.
 4. The R&D unit and Production unit should jointly develop a protocol for
the transfer of relevant Information related to the process under
consideration from the R&D unit to the production unit, As well as the
development of comparable process at the production unit.
GRANULARITY OFTT PROCESS (API, EXCIPIENTS, FINISHED
PRODUCTS,PACAGING MATERIALS)
Granularity of Technology Transfer Process deals with details of data
regarding:
Starting materials
$ Active Pharmaceutical ingredients
Excipients
Process
Finished Product
Packing Material
1. STARTING MATERIALS
The specifications of the starting materials (APls and excipients) to be
used at the RU should be consistent with reference batches
(development batches, bio-batches or batches manufactured at the
SU).Any properties which are likely to influence the process or product
should be identified and characterized.
2. ACTIVE PHARMACEUTICAL INGREDIENTS (API)
The SU should provide the drug master file (DMF) and any relevant
additional information on the API to the RU to be checked against the
specifications ofthe API. The following information should be provided:
The following information should be provided:
o Manufacturer
o Flow chart of synthesis pathway
o Definitive physical form of the API (including photomicrographs
and other relevant data) and any polymorphic and solvate forms
Solubility profile
 Partition coefficient (including the method of determination)
Intrinsic dissolution rate (including the method of determination)
o Particle size and distribution
o Bulk physical properties, including data on bulk and tap density,
surface area and porosity as appropriate;
o Water content and determination of hygroscopicity, including
water activity data and special handling requirements;
o Special considerations with implications for storage and/or
handling,e.g. safety and
o Environmental factors and sensitivity to heat, light or moisture.
3. EXCIPIENTS Feesible

An excipientsis substance like sugar;, gum etc. Cost ofe chive Pheme olegieb,

used to prepare drug so as to make it suitable Exepients

to administer.
These excipients have a potential impact on No
Interoci
with
Srable for
handling
the final product.
Theirspecifications as well as the Drug Master File (DMF) or equivalent
information should be made available by the sending unit (SU) for
transfer to the production site.
The following information should be provided for all types of excipients:
/ Description of functionality, with justification for inclusion of any
antioxidant
Preservative orany excipientsabove recommended guideline
V Manufacturer
/ Specifications ,i.e., monographs and additional information that may
affect product processing or quality for compendia excipients, or a
complete listing of specifications, incuding analytical methods and
justification for release limits for non-compendial excipients.
V Special considerations with implications for storage and/or handling,
includingbut not limited to safety and environmental factors (e.g. as
specified in material safety data sheets) and sensitivity toheat, light or
moisture solubility
4. FINISHED PRODUCTS
Depending on the type of dosage form, the SU should provide relevant
information on physical properties of excipients to the RU, including:
Definitive form (for solid and inhaled dosage forms)
Solubility profile (for solid, inhaled and transdermal dosage forms)
Partition coefficient, including the method of determination (for
transdermal dosage forms)
Intrinsicdissolution rate, including the method of determination (for
transdermal dosage forms)
Particle size and distribution, including the method of determination
(for solid, inhaled and transdermal dosage forms)
Bulk physical properties, including data on bulk and tap density,
surface area and porosity as appropriate (for solid and inhaled dosage
forms)
Compaction properties (for solid dosage forms)
Melting point range (for semi-solid/topical dosage forms)
pH range (for parenteral, semi-solid/topical, liquid and transdermal
dosage forms)
lonic strength (for parenteral dosage forms)
Specific density/gravity (for parenteral, semi-solid/topical, liquid and
transdermal dosageforms)
VViscosity and/or viscoelasticity (for parenteral, semi-solid/topical,
liquid and transdermal dosage forms)
/ Osmolarity (for parenteral dosage forms)
Water content and determination of hygroscopicity, incuding water
activity data
Special handling requirements (for solid and inhaled dosage forms)
Moisture content range (for parenteral, semi-solid/topical, liquid and
transdermal dosage forms)
Microbiological considerations in accordance with regional
pharmacopeial requirements (for parenteral, semi-solid/topical, liquid,
inhaled and transdermal dosage forms)
5. PACKAGING
Information on Packaging to be transferred from the SU to the RU include
specifications for a suitable container/closure system, as well as any
relevant additional information on design, packing. processing or
labeling requirements needed for qualification of packaging components
at the RU.
For quality control testing of packaging components, specifications
should be provided for drawings,artwork, material.
DOCUMENTATION

An authorized technology transfer document, for

example, a Master Plan (or Technology Transfer
Protocol) should list the intended sequential phaseso
and activities of the transfer, where appropriate.
The document should include the following:

1. Title

2. Objective
3. Scope
4. Name and addresses of the SU and RU

5. Key personnel and their responsibilities

6.
Phases of the project including key activities, deliverables and the
associated accountabilities

7.
Approximate timing of key activities/deliverables including the
timing of trial production batches and validation batches
8. Reference to qualification/validation master plans relevant to the
process being transferred

9. Reference to gap assessments and risk assessments

10. Acceptance criteria for a successful transfer

 A parallel comparison of premises, equipment, instruments,
materials, procedures, and methods for the transfer under
consideration.

PREMISES AND EQUIPMENT

PREMISES
The SU should provide information to the RU on the
layout, construction and finish of all buildings and
vices (heating, ventilation and air-conditioning
(HVAC), temperature, relative humidity, water, power,
compressed air).
Quality control laboratories should be equipped and capable of testing
all APls, excipients, intermediate and finished products, packaging
components and cleaning validation samples.
Buildings intended for production of a Highly sensitizing nature (e.g.
penicillin's and cytotoxic materials) should be dedicated for this
purpose and located in a different facility from other production units,
Health, safety and environmental issues, including waste management,
emergency.
Planning, minimization of operator exposure and environmental
impact, should be addressed at the RU in compliance with any
regulatory or company-developed rules, regulations and limits.
buildings and services at the RUshould be capable of accommodating
the product,
Process or method under transfer to the agreed quality standard and
production volume in compliance with GMP.
 EOUIPMENT'S
The SU should provide a list of equipment, makes and models involved
in the manufacture, filling, packing and/or control of the product,
process or method to be transferred, together with existing qualification
and validation documentation.

Relevant documentation may include: CALIBRATION

Drawings RECORD
DATE NOT DUE

Manuals
Maintenance logs
Calibration logs
Y sOPs (e.g. equipment
set up,operation, cleaning, maintenance,
calibration, storage).

SOP;Standard Operating Procedure

The RU should review the information provided by the SU together with
inventory list including the qualification status (IQ, 00, PO) of
all equipment and systems, and perform a side-by- side comparison
equipment at the two sites in terms of their functionality, makes, models
and qualification status.
Based on the side-by-side comparison, the RU should perform a gap
analysis to identify requirements for adaptation of existing equipment.
GMP requirements should be satisfied, and intended production volumes
and batch sizes (e.g. same, scaled-up or campaign) should be considered.
Factors tobe compared include:
/ Minimum and maximum capacity
V Material of construction
Critical operating parameters
V Critical equipment components (e.g. filters, SCreens,

temperature/pressure sensors)
Range of intended use.
QUALIFICATION AND VALIDATION
The extent of qualification and validation to be performed should be
determined on the basis of risk management principles, taking into
account the product's life cycle phase.
Equipment and instruments should be qualified and calibrated before
using them to support the technology transfer activities.
Process validation should be done according to guidelines as published in
current WHO Technical Report Series.
Production processes and analytical procedures should be appropriately
transferred to the RU following documented procedures. Where
validation data exist, these should be included in the transfer.
For cleaning procedures, development and validation should be done in
accordance with the guidelines as published in current WHO Technical
Report Series.
Points to consider when using HBEL in cleaning validation should be
taken into account in establishing cleaning procedures, cleanability
studies and setting acceptance limits.
Analytical procedures should bevalidated or verified according to the
guidelines as published in current WHOTechnical Report Series.
Qualification and validation procedures, protocols, data and results
should be appropriately recorded. The documents should be
as defined in procedures.

QUALITY CONTROL :ANALYTICAL METHOD TRANSFER

Analytical procedures used to test pharmaceutical products, starting
materials, packaging components and cleaning (residue) samples. at
applicable, should be implemented at the testing laboratory before the
testing of samples for process validation studies is performed by the RU.
" The transfer of the analytical procedure may be accomplished by sever.a!
approaches such as confirmation testing, comparability test1ns
between SU and RU results, co-validation between laboratories, or
through a "paper-based knowledge" transfer.
 Theanalytical procedures transfer protocol should include:

1
Adescription of the objective, scope and responsibilities of the SU and
the RU
2. Aspecification ofmaterials and methods
3. The experimental design and acceptance criteria
4. Documentation
5. Procedure for the handling of deviations
6Details oftest samples
The SU's responsibilities for the transfer of analytical procedures
typically are to:
1. Provide method-specific training for analysts and other QC staff, if
required
2. Assist in analysis of QC testing results
3. Define all procedures to be transferred for testing a given product,
starting material or cdeaning sample
4 Define experimental design, sampling methods and acceptance
criteria
5. Provide any validation reports for procedures under transfer
including proof of their robustness
6. Provide details of the equipment used, as necessary (part of validation
report, ifavailable) and any standard test samples
7 Provide approved procedures used in testing
8. Review and approve transfer reports

The appropriate training should be provided and all training activities

and outcomes should be documented.
Reference should be made to compendial monographs such as The
International Pharmacopoeia, European Pharmacopoeia, British
Pharmacopoeia and United States Pharmacopeia, where these are
relevant.
The RU should exercise its responsibility to:
1. Review analytical procedures provided by the SU, and formally
on acceptance criteria before execution of the transfer protocol
2. Ensure that adequately trained and experienced personnel are in
place for analytical testing
3. Execute the transfer protocol
4. Provide a documentation system capable of recording receipt and
testing of samples

APPROVED REGULATORY BODIES AND AGENCIES

1. THE CENTRAL DRUG_ STANDARDS AND CONTROL

ORGANIZATION (CDSCO) sTANDAROo

cONTROL ORGA,
DRUGS

In India, the Central Drugs Standard Control

Organization (CDSCO) is the main regulatory 8
body, Headquartered in New Delhi currently CDSCoCDSco
regulating import, sale and manufacture of
medical devices.
STRY OF
The CDSCO lays down standards of drugs, cosmetics, diagnostics and
devices and issues licenses to drug manufacturers and importers.
It also lays down regulatory measures, amendments to Acts and
Rules and regulates market authorization of new drugs, clinical
research in India and standards of imported drugs etc.
2. NATIONAL INSTITUTE OF HEALTH AND FAMILY WELFARE
(NIHEW)
NIHFW is an Apex Technical Institute, funded by Ministry of Health
and Family Welfare, for promotion of health and family welfare
programmers in the country through education, raining research,
evaluation,consultancy and specialized services.
The NIHFW was established on March 9, 1977 by
a merger of the National Institute of Health
Administration and Education (NIHAE) with the
National Institute of Family Planning (NIFP).
3. DRUG TECHNICAL ADVISORY BOARD(DTAB)
The Central government constitute a board to
advice the central government and the state DTAB
governments on technical matters arising out Drugs Technical Advisory Board
of the administration ofD &C, Act 1940. it advices matter related to drugs
4. CENTRAL DRUG TESTING LABORATORY (CDTL)
The Central drug laboratory, Kolkata is national statutory laboratory
of the government of India for quality controlof drug and cosmetic and
established under the D & Cact 1940
It is the oldest quality control laboratory of the drug control
authorities in India
Functionsunder the director general of health services in the ministry of
health and family welfare
5. USFDA
The Food and drug administration (FDA) is an agency within the U.S
department of health services.
The Food &Drug modernization act states that the FDA has 4 roles:
To promote health by reviewing research and approving
products
V Toensure foods and drugs aresafe and properly labelled
/ To work with other nationsto "reduce the burden of regulation"
/ To cooperate with scientific experts and consumers to effectively
carry out these obligations.

FDA
COMMERCIALIZATION -PRACTICAL ASPECTS AND
PROBLEMS (CASE STUDIES)
COMMERCIALIZATION
The process of turning an innovation or creative Capab1lities
Ideas
into a financially viable product, service, or lunevatons Technologies
method is known as commercialization
Before the study results can be brought to market, Commereializationl

additional R&D, product development, clinical

studies, or the development of strategies to boost
manufacturing may be required. New Products

* COMMERCIALIZATION-PRACTICAL ASPECTS:
S.NO AMONG THE MOST IMPORTANT ASPECTS OF
cOMMERCIALIZATION ARE
Commercialization involves testing many ideas and selecting the
1. products that can be safer, more effective, and more efficacious than
the existing product.

2.
Commercialization is a step by step process. Therefore, set goals and
milestones for every stage.

3.
It is important to involve key stakeholders, including customers,
early in the process, including customers.
By improving the technology Time

transfer and commercialization Fund

Focused managenment
contextual conditions, countries can of the entire process oWner
increase innovation in the from idea to market Creative
including IP rights effort
economy and thereby raise
productivity, create better job Govt Innovations
opportunities, and address Policies

societal challenges.
Not surprisingly, governments have been actively searching for new ways
to improve knowledge transfer from PROs to industry.
TT AGENCIES IN INDIA -APCTD, NRDC, TIFAC, BCIL, TBSE/
SIDBI

ASIAN AND_ PACIEIC CENTRE FOR TRANSFER OE

TECHNOLOGY (APCTT)
APCTT
It isa United Nations Regional Institution under the Economic and Social
Commission for Asia and the Pacific (ESCAP) established in 1977 in
Bangalore, India.
In 1993, the Centre moved to New Delhi, India. APCTT promotes
transfer of technology to and from small- and mnedium-scale
enterprises (SMEs) in Asia and the Pacific.
APCTT implements development projects funded by interna
donors aimed at strengthening the environment for technology transfer
among SMEs.
The objective of APCTT is to strengthen the technology transfer
capabilities in the region and to facilitate import/export of
environmentally sound technologies to/from the member countries.
NATIONAL RESEARCH DEVELOPMENT CORPORATION
(NRDC)
was established in 1953 by the Government of India, with the
primary objective to promote, develop and commercialize the
technologies/ know-how/ inventions / patents/ processes
emanating from various national R&D institutions/Universities
and is presently working under the administrative control of the Dept.
of Scientific &Industrial Research,Ministry of Science &Technology.
It is recognized as a large repository of wide
technologies spread over almost all L 3R S0 T
range of
areas of industries, viz. Agriculture and Agro
processing, Chemicals including Pesticides,
Drugs and Pharmaceuticals, Bio Technology,
Metallurgy, Electronics and Instrumentation,
Building Materials, Mechanical, Electrical and
Electronics etc.
NRDOC
TECHNOLOGY INFORMATION, FORECASTING AND
ASSESSMENT COUNCIL (TIFAC)
TIFAC is an autonomous organization set up in 1988 under the
Department of Science & Technology to look ahead in technology
domain, assess the technology trajectories, and support innovation
by networked actions in selected areas of nationalimportance
TIFAC embarkedupon the major task of formulating a Technology Vision
for thecountry in variousemerging technology areas.
Under the leadership of Dr. APJAbdul Kalam, Technology Vision 2020
exercise led to set of 17 documents, including sixteen technology areas
and one on services.
While inaugurating the 103rd Indian Science Congress in Mysuru,
Hon'ble Prime Minister of India Shri Narendra Modi released the
Technology Vision 2035 prepared by TIFAC.
This is being followed by release of Technology Roadmaps in 12 thematic
areas of national priorities and importance Education, Medical Science &
Health Care, Food and Agriculture, Water, Energy, Environment, Habitat,
Transportation, Infrastructure, Manufacturing, Materials and
Information &Communication Technologies (1CT).
BIOTECH CONSORTIUM INDIA LIMITED (BCIL)
Biotech Consortium India Limited (BCIL),
International
New Delhi was incorporated as public Organizations

limited company in 1990 under The Central & State

Government
Research
Institutions
Companies Act, 1956.
The sortium is promoted by the BCIL
Industry
Departmentof Biotechnology,Government of Universities

India and financed by the All India Financial Financial

Institutions
Institutions and some corporate sectors.
BCIL's Major functions include the development and transfer of
technology for the commercialization of biotechnology products,
project consultancy, biosafety awareness and human resource
development
 TECHNOLOGY BUREAU FOR SMALL ENTERPRISES (TBSE)/
SMALL_ NDUSTRIES DEVELOPMENT BANK_ OF_ INDIA
(SIDBI).
TBSE is a platform for MSMEs to tap opportunities at the global level for
the acquisition of technology or establishing business collaboration.
TBSE is a result of the cooperative initiative of the United Nations Asian
and Pacific Centre for Transfer of Technology (AP CTT) and Small
IndustriesDevelopment Bank of India (SIDBI) in 1995.
TBSE also receives partial funding from the Office of DC (SSI),
Government of India.
Features of TBSE Offering a professionally managed system for the
reasons of technology and collaboration exploration helping in the
building up of confidence between potential partner.
It providing an opportunity to global technology market through the
process of networking. Taking up project appraisal and the preparation
of a business plan.
The new technologies for the reason of transfer are sourced from
tries namely China, Philippines, South Korea, Australia, Germany, as
well as the U.S.

TT RELATED DOCUMENTATION CONFIDENTIALITY

AGREEMENT, LICENSING, MoUs, LEGAL ISSUES.
CONFIDENTIALITY AGREEMENT Confidentiality
agreement

It is also called as non-disclosure agreement (NDA). It is

used to protect the proprietary nature of the
technology and retain the confidentiality of a
technology or invention.
The drafting of the appropriate clausescan be essential
SUREA
for the maintenance of the value of the technology.
The need of this agreement is due to the increase in AGRE
EMEN
competition and the new technologies can be exploited.
Thus, it is necessary to obtain protection to the
continuous innovation process through confidentiality
agreements.
 LICENSING
The legal core of the transfer of technology is constituted by a licensing
agreement.
By signing this agreement the owner of a technology, the licenser, gives the
right to another company, the licensee, to make use of this technology.
A
license does not alter the property rights of the owner: he remains the
only proprietor of the technology.
LICENSE
The license agreement is generally referred to the licensing
of intellectual property rights such as; patents, trademarks,
copyrights, etc. This agreement has a role on maintaining the
confidentiality and secrecy aspects of the contract.
MoUs
MoU stands for Memorandum of Understanding
A Memorandum of Understanding is an agreement between two or more
parties outlined in aformal document.
It is not legally binding but signals the willingness of the
parties to move forward with a contract.
MOUs communicate the mutually accepted expectations
of all of the parties involved in a negotiation.
The MOUis most often found in international relatio
LEGAL ISSUES
The following types legal issues are generally observed in technology
transfer:
/ Legal contractual agreements
Tax implications
Legal issues in intellectual property transaction
Problems associated with IPR litigation
/ Legislations covering IPRs in India