1.

Drawing in every applicable legislative and regulatory provisions and

practice in place for regulations of pharmaceuticals In Nepal, Prove how
medicines for public use are ensured for its

i. Safety

ii. Efficacy

iii. Quality

iv. Affordability

v. Rational use, preventing Misuse and Abuse

vi. Availability

Pharmaceutical laws and regulations across the world play an important role in ensuring the
safety and efficacy of the approved drugs. They not only regulate the pricing of drugs but the
quality as well. The regulations are required both for new innovations and already existing
products, both products which are produced domestically and those imported from other
countries require regulation. Every country has its own regulations which apply to innovation,
manufacturing, drug testing, marketing, and post marketing studies. The aim is to maintain the
standards of the drug at every step to cater for the patient population of each country.

In addition, the legal and economic issues that surround pharmaceuticals have become more
complex and politicized because of the increase in global trade. Laws and regulations are
intended to be used together to achieve their objective. Simply put laws are big picture and
regulations are the bit narrower actionable task you take to maintain those laws. National drug
legislation generally includes provisions relating to the manufacturing, importing, distribution,
marketing, prescribing, labeling (including language), dispensing, and sometimes pricing of
pharmaceutical products, as well as the licensing, inspection, and control of personnel and
facilities. A regulatory authority is usually established for administrative control. Medicine
registration is often a major element in legislation, to ensure that individual products meet the
criteria of efficacy, safety, and quality.

In Nepal, there are legal provisions establishing

the powers and responsibilities of the Medicines Regulatory Authority (MRA). Department of
Drug Administration (DDA) is the medicine regulatory authority. The MRA receives external
technical assistance only from WHO in HRD and some other identified technical areas to
support its activities. The MRA is not involved in harmonization/collaboration initiatives. So here
we are discussing how legal and regulatory practice ensuring the safety, effectiveness, quality,
affordability, Rational use, preventing Misuse and Abuse and availability of pharmaceuticals.
1. Safety, Efficacy and Quality
Proven quality, efficacy, and safety of our medicines: A must! Core Elements of Regulatory
Systems

A. Drug act and Regulations

Having safe, efficacious and standard quality medical products is a cornerstone of public
health around the world. Drug Act 2035 has been published with seven chapters and
forty sections in the act. All the sections in the Drug act are more or less related to
ensuring safety, efficacy and quality in one way or another,
Though, Chapter 5 in general of Drug Act is related to maintaining the standard of quality
of drugs which ensures:
I. Drugs to be safe, efficacious and of standard quality.
II. Prohibition of manufacture, sale- distribution, export-import, storage or
administration of non standard drugs.
III. Return of drugs, which are not safe, efficacious and of standard.
IV. Remittance of indemnity.

Thus, The Department of Drug Administration (DDA) protects Nepalese consumers from
tainted products, and increasingly it works with its counterpart agencies in nation and
abroad to the same ends such that the core elements of drug regulation are sustained.

B. WHO BLUE BOOK

Drug regulation is a public policy that restricts private-sector activities in order to attain social
goals set by the State. Drug regulation is the totality of all measures⎯ legal, administrative and
technical ⎯ which governments take to ensure the safety, efficacy and quality of drugs, as well
as the relevance and accuracy of product information. Public health and safety concerns have
obliged governments to intervene in the activities of the pharmaceutical sector.The proposed
strategies that can help policy-makers and implementers to improve drug regulation.

 Regulatory Framework
 DAC & DCC are directly responsible for formulating codes for doing, or
causing to be doneFor the production, sale, export, import of publicly
safe, efficacious and qualitative ingredients and formulation as a whole.
 DDA to fulfill the objectives of Drug Act, 2035

 Licensing of manufacturing, distribution and retail sale

 Inspection and surveillance

 Product assessment and registration

  Drug quality control laboratory:

. It is the principal body of government of Nepal for testing and analysis of drugs. It is a
National Drug Control Laboratory. It has various sections like chemical analysis,
microbiology, pharmacology & instrumental analysis. The main functions of NML are

 Test and analyze the quality of drug as empowered according to the Drugs Act, 1978.
 Check & evaluate the standard of drug testing laboratories in the country.
 Develop reference standard and make available to the pharmaceutical industries &
laboratories.
 Conduct training on Good laboratory practices.
 Audit laboratories of National Pharmaceutical industries.

C. Consumer protection Act, 2054

With globalization, we observe that there is a plethora of Drugs and services. It is important
for a Consumer to have important support in purchasing the right goods and services and
have their grievances redressed whenever they arise in some occasions. The consumer
protection Act, 2054 was enacted for the better protections of the interests of the consumers.
Consumer protection act imposes strict liability on a manufacturer, in case of supply of defective
Drugs or service provided by him, against exploitation by unfair trade practices, It provides them
with the basic rights such as the right to be protected against hazardous goods, right to protect
themselves against Unfair Trade Practices, right to seek Redressal, the right to Consumer
education, etc. As a whole, this Act empowers the consumers to fight against the malpractices
of the Seller. It helps in empowering every single consumer and makes it a Consumer-Centric
Market thus uplifting the safety, efficacy and quality of drugs.

D. WHO Certification scheme

Safety, quality and efficacy of pharmaceutical products moving in international markets have
always been of great concern to WHO. In this regard, WHO created the Certification Scheme
onthe Quality of Pharmaceutical Products Moving in International Commerce, among other
mechanisms, as a means of assisting Member States to improve their national systems for
quality assurance of drugs. The Scheme provided for: a) the exporting country to establish, after
inspection, an up-to-date list of manufacturers complying with GMP which could be exchanged
between governments; and b) the issuance of batch certificates by the responsible health
authorities of the exporting country.

The GMP declaration in the CPP refers to assurance of GMP for the product approved in the
certifying country at the stated manufacturing site and the CPP is based on the assumption that
the authorities issuing a CPP have the capacity to assess the quality, safety, and efficacy (QSE)
of the product they approve for marketing.
E. Pharmacopoeia
Pharmacopoeia as quality codex for the manufacturers. The quality of drugs, pharmaceutical
adjuvants or preparations listed in a modern pharmacopoeia must be considered by the industry
as the minimum level of the acceptable standard for medical use, to ensure efficacy under
proper storage conditions .Pharmacopoeias, the official books of drug quality standards .
Before medicines are marketed, assess their safety, efficacy and quality.

F. ICH GUIDELINE
 .Harmonization achievements in the Quality area include pivotal milestones such as the
conduct of stability studies, defining relevant thresholds for impurities testing and a more
flexible approach to pharmaceutical quality based on Good Manufacturing Practice
(GMP) risk management.
 The work carried out by ICH under the Efficacy heading is concerned with the design,
conduct, safety and reporting of clinical trials. It also covers novel types of medicines
derived from biotechnological processes and the use of pharmacogenetics/genomics
techniques to produce better targeted medicines.
 ICH has produced a comprehensive set of safety Guidelines to uncover potential risks
like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a
non-clinical testing strategy for assessing the QT interval prolongation liability: the single
most important cause of drug withdrawals in recent years.

G. National Medicines Policy – 2007

 National Medicines Laboratory (NML) will be developed as an independent National
Control Laboratory (NCL), improved capability with the provision of modern equipment
and trained staffs and strengthened to carry out the testing of vaccines and biological
products.
 Department of Drug Administration (DDA) will be strengthened by addition of human
resources and infrastructure development to make it more efficient National Medicine
Regulatory Authority (NMRA) to regulate modern, traditional and complimentary
medicines for human and veterinary use, as well as allied products like nutritional
supplements, cosmetics, medical devices, diagnostic agents and other health promotion
products.

 The branch offices of the Department of Drug Administration will be established to cover
various parts of the country as required.

 Registration of medicine will be based on scientific evidence. The manufacture, import,

sale and distribution of ineffective, harmful, toxic as well as irrational combination
formulation will be banned. e
2. Rational use, preventing Misuse and Abuse
In Nepal, Laws exist for the control of narcotic and psychotropic substances, and precursors.

 Drug Act, 2035:

 Chapter 5, Section-18 ensures the prohibition of misuse or abuse of drugs.
 Chapter 7, Section -33, protection of narcotic and poisonous drugs.

 Narcotic Drugs Act, 2033

 Control on the cultivation, production, preparation, sales, and purchase, store transport,
administration and export import of narcotic drugs with provision for penalty and power
to frame rules or issue orders.
 Responsibility of the Medical Practitioner:
 Shall not prescribe it to those who do not need it or prescribe more than what the
requirement is even to those to whom it is required.
 Note to be made on the prescription Paper of the Medical Practitioner.

 National Medicines Policy – 2007

 Rational use of medicine will be promoted by constituting Drugs and Therapeutics
Committee, involving the pharmacists in the pharmacy services at all level of hospitals.
 Public health and health education programme and other programmes relating to
Rational Use of Medicine.
 Medicine Information system will be strengthened to disseminate the relevant
information about rational use of medicines, adverse reaction, toxicity, side effects etc to
all concerned through different media. Revision of Nepalese National Formulary will be
done on regular interval and Drug Bulletin of Nepal will be published regularly.
 Prudent Use of Antibiotics:
 Prevailing antibiotics use in food products, animal feeds and agriculture substances will
be managed properly.
 Supervision and monitoring on use of antibiotics will be carried out. Misuse will be
controlled and proper record keeping system will be developed.
 Treatment protocols for antibiotics use will be developed .A sub committee comprising of
experts from relevant sector to advice on prudent use of antibiotics to be constituted.
 Policies to promote rational use of medicines
 Monitoring and supervision of prescribing / dispensing
 Standard Treatment Guidelines (STGs)
 National Formulary
 Drug Information Centre
 Independent drug information
 Drug and Therapeutics Committees
 Undergraduate education on medicine use
  Continuing Medical Education and medicines use
 Public Education on the safe and prudent use of medicines
 Generic Policies.

 UN consolidated list of restricted drugs

This is a service offered to drug regulators, the pharmaceutical industry, and to everyone
interested in assuring the safe and rational use of drugs. Updates are issued on alternate years,
providing new information on national regulatory decisions and on voluntary withdrawal of
products by manufacturers on grounds of safety. It constitutes a tool which helps governments
to keep current with regulatory decisions taken by other government and assist them in
considering the scope for their own eventual regulatory actions based on consolidated
information on the subject produced within the United Nations system.

 National Policy for Drug Control, 2063 ( 2006 )

 Supply control:
 Restriction in illicit farming and production of cannabis and opium.
 Illicit transport, sale and distribution of drug shall be controlled.
 Fostering coordination and collaboration to destroy organized network of drug mafias.

 Demand control
Demand reduction refers to efforts aimed at reducing the public desire for illegal and illicit
drugs.

3. AFFORDABILITY AND AVAILABILITY

Availability
Public sector availability of the medicines for free distribution is assured by effective logistics
management information system and procurement system. Availability in the private sector is
better due to commercial viability, large number of stockiest, distributors and retailers.

Affordability
Affordability of medicines is measured in terms of the number of days’ of wages necessary to
purchase a particular treatment for a specific condition. The wage considered is that paid to the
lowest paid government worker in Nepal.

A. National Drug Policy -1995 (Strategy)

 Drug Management
Selection of Essential Drugs and National Lists of Essential Drugs for use in Governmental
health care service in accordance with WHO`s concept of essential drugs.
  Procurement, storage and distributions of drugs at different
health institutions.
 Procuring necessary drugs by accepting tenders from a list of standard manufacturers
or their authorized agents
 Procurement of essential drugs by GoN will be made under generic names.
 In order to ensure sufficient volume of the required drugs at different health institutions,
the schemes related to partial or full cost-sharing will be implemented phase-wise.
 The mechanism of procurement and distribution of drug will be modernized to assure
timely supply of drug to all health institutions.

B. Essential medicine list of Nepal

The national EML 2011 contains 321 drugs divided into core and complementary, but not by
level of prescriber or facility. The government is currently supplying 40 of these medicines for
free distribution at government health facilities at district level, but have recently increased this
list to 70 drugs, a few of which are not on the current EML. The development process for the
national EML involves a core team in the DDA and input from various specialists. Procurement
of medicines for all government and semi-government health institution is made in accordance
with the National List of Essential Medicines so as to ensure the availability of essential
medicines.

C. Universal Health Coverage- WHO

Universal health coverage is defined as ensuring that all people have access to needed health
services (including prevention, promotion, treatment, rehabilitation and palliation) of sufficient
quality to be effective while also ensuring that the use of these services does not expose the
user the financial hardship.

 Strategic Direction
 Strengthening national institutions and capacities for universal health coverage
 Placing primary health care-oriented health systems strengthening in the context of
universal health coverage.
 Improving equity in financial coverage.
 Improving equity and efficiency in service coverage.

D. The TRIPS Agreement

The TRIPS Agreement sets minimum standards in the international rules governing
patents, including on medicines.
The Doha Declaration: restoring the balance

Implementation of the TRIPS Agreement’s intellectual property standards is having a

considerable impact on access to medicines and public health. By limiting competition and local
manufacturing, the danger is that TRIPS extends high drug prices and worsens the access to
medicines crisis.

With TRIPS, life-saving medicines are considered in the same vein as mere consumer goods
and the devastating impact of high prices is mostly ignored. The balance between the private
interests of the patent holder and the larger interests of society is severely skewed.

It didn’t take long for the issue to come to a head. In 2001, at the annual ministerial meeting of
the WTO in Doha, Qatar, countries agreed to redress that imbalance, and firmly restated the
primacy of health over commercial interests. The Doha Declaration reaffirmed countries’ right to
use TRIPS safeguards such as compulsory licences or parallel importation to overcome patent
barriers to promote access to medicines, and guided countries in their use. One final significant
achievement of Doha was to extend the deadline by which the least developed countries had to
grant and enforce pharmaceutical patents, so Countries like Nepal will not face the same
difficulties that other developing countries already contend with in accessing medicines.