National drug policy of Nepal
National drug policy of Nepal
Published on: Mar 3, 2016
Transcripts - National drug policy of Nepal
National Drug Policy
Ratan Bahadur Mahatara
Review of National Health Policy
With the core objective to upgrade the health standards of the majority
of the rural population by extending basic primary health services
and making modern medical facilities available at the village level,
Nepal’s government introduced a National Health Policy in 1991.
It called for prioritising preventive, promotive and curative health
services to reduce infant and child mortality.
The policy has 15 components ranging from preventive health
services to blood transfusion services and miscellaneous issues.
Among them one of its issue was Drug supply which stated:
In order to bring about improvements in the supply of drugs in
government health organizations as well as those operated under the
private sector, the domestic production of essential drugs will be
The quality of the drugs will be upgraded by revising the National Drug
National Drug Policy
In accordance with the objectives of the National Health Policy 1991,
National Drug Policy was introduced in 1995.
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
to manage effectively all the drugs-related activities including
production, import, export, storage, sale, supply and distribution.
a. To evolve a suitable mechanism to ensure availability of safe,
effective and quality medicines at reasonable price throughout
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
c. To supply adequate quantities of essential drugs at each level of
Governmental health institutions.
d. To include drug industry as priority sector by all concerned
Ministries of HMG in order to make the nation self-reliant in the
production of essential drugs.
e. To develop pharmacy manpower for effective implementation
of the 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 to
carry out testing, analysis and standardization of
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 system of medicine by adopting scientific
j. To improve the existing infrastructure of the
Department of Drug Administration and provide
sufficient qualified and trained personnel for
strengthening the drug administration mechanism
and effective of the Drug Act.
k. To consolidate and amend the existing Drug Act,
National Medicines Policy – 2007 (Revised NDP)
To strengthen Department of Drug Administration as
National Medicine Regulatory Authority (NMRA) and
National Medicines Laboratory as National Control
Laboratory (NCL) for the effective enforcement of the
To ensure proper monitoring and reporting of Adverse
Drug Reactions (ADR) for implementation of
To encourage collaboration among universities, research
institutes and manufactures for promoting research &
To encourage transfer of technology by allowing contract
manufacturing by foreign manufacturers with the
Procurement, storage and distribution of medicines
Quality assurance and regulatory measures
Rational Drug use and its information
National drug industry and
Progress achieved so far with NDP
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
Branch offices of Department of Drug Administration established in
three regions of the country.
National Medicines Laboratory was developed as National Quality
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
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
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
National Drug Policy done twice.
Current situation: Loss in efficiency for the Essential Drugs
procured by the districts
The estimated loss of efficiency
10% for additional
30 percent for higher prices
paid by the districts due to
lower quantities to be
Option: Centre Procures All ED, Budgets Remain at Respective
At the Level of Guiding Principles
• Free health service policy should be supported by a sound procurement and
supply system to ensure round-the-year availability of ED.
• Centre may take over the responsibility of quality assurance of drugs.
At the Level of Implementation
• At centre and district level: Re-directing budget and procurement responsibilities
to the centre, at least for the main ED.
• Central bidding, and price negotiation and local purchasing of the ED.
For Future Follow-up Activities
• A study on the ED-prescribing behaviour of the health workers particularly after
the implementation of FHCP should be conducted.
• A national level study should be conducted on pricing of all ED
Include drug industry as priority sector
Major objective: to produce 80 per cent of the essential drug formulations in the coming
After ten years, we have achieved only 45 per cent of the total target.
The domestic sector at present claims a-three billion rupees worth of market, which is
around 35 per cent of the total eight billion rupees pharmaceutical market in Nepal.
Foreign companies occupy almost 65 per cent of the drug market. Even among the
foreign brands, Indian companies are dominant.
Other problems in the Nepali pharmaceutical sector
VAT and extra taxes.
Smuggling of drugs through the porous Indo-Nepal border.
Too many players and lingering doubts over the quality of the medicines produced.
( 40 Nepali companies alongwith 201 foreign companies, they are offering 7,299 brands)
Unlike other products where more brands usually mean more choice for consumers, the
large number of brands in the pharmaceutical sector is only encouraging unhealthy
There should be no VAT and extra tax on raw materials, packaging material and
Reducing the number of brands to control unhealthy practices.
The practice of giving incentives is unethical in pharma business and should be
Some foreign companies, which were inspected long time back need re-inspection.
Government should have a well-equipped body for quality control. The quality
is tested once when a foreign company registers its products. Further checking is
done every year or on specific complaints. This practice should be discouraged.
Instead Medicines entering Nepal should be regularly tested at the customs
points by the authorities.
All the domestic companies start producing at least one essential and one life-saving
Rational Use of drugs
The requirements for rational drug use are that the right drugs shall be used for the right
indications in the right dose and dosage form for the right duration.
Nearly 42% of the health budget is spent on drugs and international donors spend another
three times, 80% of medicinal products are imported to Nepal however, the availability of
drugs in the health posts and clinics are sporadic resulting into the prevalence
of inappropriate drug use.
Concerted efforts shall be made by government at all levels to promote rational drug use
The objective is to ensure that drugs are prescribed rationally
• Up-to-date Standard Treatment Guidelines and a National Formulary shall be made
available to all prescribers according to the level of care;
• Prescribing shall be by International Non-Proprietary Names (INN) or generic names
The objective of rational dispensing shall be to ensure that patients receive adequate
information on the use of dispensed drugs in order to derive the desired benefits
to them. In this regard the following shall be put in place:
i. Dispensing shall only be carried out on duly licensed premises;
ii. The minimum information requirement on the label of a dispensed medicine shall be the
• Name of patient,
• Generic name of dispensed drug,
• Strength of the drug,
• Dosage instruction in symbols or words as may be appropriate,
• Duration of treatment
• Date of dispensing, and
• The name of the institution where the drug was dispensed;
iii. The patient shall be counselled on the use of dispensed drugs, in a conducive
environment suitable for effective communication; and
iv. Dispensing shall be carried out in a suitable container that will be child proof
and ensure the stability of the drug dispensed.
Drugs and Therapeutics Committees (DTCs) shall be established in all health care
institutions which will be responsible for:
· the selection of drugs for use in the institution, based on the National Essential Drug List,
· the accurate estimation of pharmaceutical requirements for the
· monitoring of the use of therapeutic guidelines and overall drug
· monitoring of the rational use of drugs in the institution
Uniformity in drug price
In drug Act 2035
If it is deemed necessary , the department with taking approval of His Majesty's
Government may fix the price of any drug.
Till date, the price of drugs fixed are
In India, retail price of drug formulations is fixed as per Drug Price control order (DPCO)
R.P. = ( M.C.+C.C.+P.M.+P.C. ) * ( 1+ MAPE / 100 ) + ED.
WHERE, R.P. = RETAIL PRICE
M.C.= MATERIAL COST
C.C.= CONVERSION COST
P.M.= PACKAGING MATERIAL COST
P.C.= PACKING CHARGES
ED = EXCISE DUTY
MAPE= MAXIMUM ALLOWABLE POST
FROM DATE OF RECEIPT OF COMPLETE INFORMATION GOVT. FIX RETAIL
PRICE WITHIN 2 MONTHS.
FOR PRICE REVISION OF SUCH FORMULATION MANUFACTURER SHOULD
APPLY WITHIN 30 DAYS.
WITHOUT APPROVAL OF GOVERNMENT,
MANUFACTURER CAN NOT INCREASE RETAIL PRICE OF DRUG.