Pharmaceutical policy of Nepal

1. By:
Sajan Maharjan
M.Pharm, 1st Year (2nd Sem)
Kathmandu University
Pharmaceutical Policy
Introduction
With the basic objective to provide “Health for all”, National Health Policy came into existence
in 1991. In order to fulfill the commitment of Government of Nepal to improve and manage by
establishing co-ordination among the governmental, non- governmental and private
organizations involved in the activities related to drug production, import, export, storage,
supply, sales, distribution, quality assessment, regulatory control, rational use and information
flow, the National Drug Policy came into existence in 1995. National Drug Policy makes a
commitment to a goal and guides for action which expresses and prioritizes the medium to long
term goals set by government for the pharmaceutical sector and identifies the main strategy for
attaining them.
The main Pharmaceutical Policy of Nepal as per National Drug policy 1995 is to maintain
safeguard and promote the health of people by making the country self- reliant in drug
production; ensuring the availability of safe, effective, standard, and quality drugs at affordable
price in quantities sufficient to cover the need of every corner of the country; and to manage
effectively all the drugs-related activities including production, import, export, storage, sale,
supply and distribution.
Objectives
The main objectives of this policy are:
a. To evolve a suitable mechanism to ensure the availability of safe, effective and quality
medicines at reasonable price throughout the country.
b. To adopt a well-defined and effective mechanism for procurement, transportation, sale-distribution,
storage and dispensing of drugs at various levels of governmental and non-governmental
health institutions.
c. To supply adequate quantity of essential drugs at each level of government health
institutions.
d. To include drug industries as priority sector by all concerned ministries of Government of
Nepal in order to make the nation self-reliant in production of essential drugs.
e. To develop pharmacy manpower for the effective implementation of the drug policy.
f. To promote rational use of drugs and to establish a drug information system.
g. To set up a well-equipped quality control laboratory with trained staff under the Ministry
of Health and Population to carry out the testing, analysis and standardization of drugs.
h. To develop an appropriate system to administer and monitor uniformity in drug prices.
i. To define, promote, and regulate the quality and standards of Ayurvedic, Homeopathic,
Traditional and other systems of medicine by adopting scientific approach.

2. j. To improve the existing infrastructure of the Department of Drug Administration (DDA)
and provide sufficient qualified and trained personnel for strengthening the drug
administration mechanism and effective enforcement of the Drug Act.
k. To consolidate and amend the existing Drugs Act, Rules and Regulations to facilitate
effective implementation of the Drug Policy.
Policy Strategies
In order to fulfill the objectives of National drug policy, following strategies has been taken:
1. Drug management
2. Quality assurance and regulatory measures
3. Rational Drug use and its information
4. Manpower development
5. National drug industry
6. Traditional medicines
1. Drug Management
The policy aims at preparing National Lists of Essential Drugs for use as per WHO’s concept
of essential drugs. For scientific and systematic procurement, storage and distribution of drugs
at different health institutions, policy aims at procuring necessary drugs by accepting tenders
from a list of standard manufacturers or their authorized agents and procurement of essential
drugs to be made under generic names. Similarly, drug related activities such as procurement,
distribution, storage and dispensing at governmental as well as non-governmental institutions
will be carried out by qualified pharmacy personnel only. Policy also aims at establishing
regional offices of DDA at all five regions in the country for proper drug management within
the country.
2. Quality assurance and regulatory measures
Policy aims to develop National Medicines Laboratory as independent National Quality
Control Laboratory and regional drug testing laboratories to be set under this. Drug
registration will be based on scientific facts and submission of GMP certificate will be made
compulsory for registration of manufacturers of imported drugs. A definite custom point will
be identified for entrance of imported pharmaceuticals into the country and the policy aims to
meet standard of locally manufactured drugs with National Code of Drug Manufacturing
Conduct.
3. Rational Drug use and its information
To promote rational use of drugs, the health workers at all levels who are eligible to prescribe
drugs will be trained regularly in “Standard Drug Treatment Schedule” and qualified
pharmacists will be involved in the pharmacy services at all levels of hospital services.

3. Similarly, Curriculum for training on different aspects of drugs will be developed and training
will be conducted for pharmacists and other health personnel.
For proper drug information, National Drug Formulary will be published that includes
information about proper use of drug, adverse reaction, pharmacology, toxicity, standard and
efficacy etc. Policy aims to bring out Nepalese Pharmacopoeia consisting of individual
monographs, standards of drug materials and accessory raw materials to be used in a
formulation. Similarly policy aims to control prudent use of antibiotics by supervision,
monitoring and control of misuse through control committee comprising of experts from
human and animal health, agriculture and representation from professional
organizations/councils and organizations involved in consumers right and other sectors for
prudent use of antibiotic.
4. Manpower development
The policy aims to encourage the academic institutions for the production of qualified
pharmacy manpower required for the country through quality education. A Pharmaceutical
Affairs Unit will be set up in the Ministry of Health and Population for effective coordination
of activities pertaining to pharmaceutical development and Regulatory measures will be
adopted to bring registration to pharmacy manpower involved in the various activities under
the pharmaceutical profession.
5. National drug industry
The main objective of the policy is to accord a status to domestic pharmaceuticals among
national priority sectors and make them self-reliant in the production of essential drugs. For
this, entrepreneurs will be encouraged to promote and establish pharmaceutical industries,
production of active ingredients, excipient and packaging materials will be encouraged,
facilities will be provided in the importation of machineries, equipments, raw materials,
excipients and packing materials and first priority will be given to domestic products while
purchasing for public sector. Similarly, private sectors will also be encouraged to set up
quality control laboratories for drugs to be used within the country.
6. Traditional medicines
With development of allopathic medicines, the policy aims to promote activities related to
drugs under Ayurvedic, Homeopathic, and other systems suitably by involving qualified
personnel and related technologies, both at governmental and private sectors.
Research and development
A rigid plan has not yet been developed in the field of research and development but the policy
aims at the research in improved pharmaceutical technology for production of bulk drugs as well
as development of new drug delivery systems. Similarly, it aims to conduct clinical trials of
drugs through Nepal Health Research Council at the institutions recognized by Government of
Nepal.

4. Technical Co-operation
In the case of technical cooperation, Government of Nepal will encourage involvement of
national and international agencies in areas of pharmaceutical manpower training and transfer of
technology. Similarly, technology transfer between national industries as well as Universities
and Industries will be encouraged and facilitated.
Implementation Plan
For implementation of this policy, implementation plan shall be prepared and revised every five
years on the basis of current situation analysis.
The implementation plan shall identify the basic problems and measures to be taken, the targets
to be achieved in quantitative terms in a specified time and prepare an estimate of the resources
needed to implement the plan and identify the sources of funding and support.
Monitoring and Evaluation
The committee constituted by Government of Nepal will be given full responsibility for
monitoring and evaluation of implementation of this policy.
Progresses made in the various strategies till date
 National List of Essential Drugs published in 1986 and revised in 1992, was revised in
1997 and 2002 and list was further classified for district, primary health care centre,
health post, sub-health post and primary treatment level.
 In order to ensure availability of required essential medicines at different health
institutions, community drug programme (cost sharing schemes) was implemented in 47
districts Health post / Sub health posts.
 Brach offices of Department of Drug Administration established in three regions of the
country.
 National Medicines Laboratory was developed as National Quality Control Laboratory.
 Good Manufacturing Practices as per WHO guidelines was made compulsory for
registration of medicine.
 Eight custom points were identified for the importation of drugs.
 Standard treatment schedule for Health Post and Sub Health Post was revised in 1999.
 Training on Good Manufacturing Practices was conducted.
 Drug Information Network of Nepal was established and made functional.
 Nepalese National Formulary was published in 1997.
 A Pharmaceutical Affairs Unit (named as Pharmaceutical / Quality Standard Section)
established at the Ministry of Health & Population.
 Bachelor level Pharmacy education started at four Universities and Diploma (Certificate)
level education started at twenty one institutes under Council for Technical Education
and Vocational training (CTEVT)

5.  Nepal Pharmacy Council Act promulgated in 2000 and registration of pharmacy
personnel started.
 The number of domestic modern medicines industries increased to 40 and are producing
215 essential drug items out of 493.
 Three quality control laboratories were established in private sector.
 Number of industries for the production of traditional medicines increased to 33.
 Evaluation of new formulations of traditional medicines on scientific basis carried out by
Department of Ayurveda.
 National Guidelines for Use of Pharmaceuticals for clinical trial developed by Nepal
Health Research Council.
 One industry established in joint venture and another has technical collaboration with a
foreign company.
 Monitoring and evaluation of progress made in implementation of National Drug Policy
was done twice.
References:
 National Drug Policy 1995
 National Medicine Policy 2007 (Draft)