National Drug Policy

National Drug Policy shall focus on effective drug management processes, such as rational drug selection, proper quantification of drug needs at all levels of health care delivery, and effective procurement practices.

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NATIONAL DRUG POLICY
INTRODUCTION
A national drug policy is a comprehensive framework in which each component plays an
important role in achieving one or more of the general objectives of the policy (access, quality
and rational use). The policy should balance the various goals and objectives, creating a
complete and consistent entity. Over the past 40 years the Indian pharmaceutical sector
witnessed rapid growth and transformation. Moreover, the industry registered a sales turnover of
about 5.5 billion U.S. dollars and an annual growth rate of about 17%.
The flexible provisions of the Patent Act of 1970 and other supportive policies of the
Government of India played an instrumental role in the growth and development of the
Pharmaceutical Industry in India. Moreover, the public policies influencing the present structure
of the industry reviews in brief the important policy changes that have taken place in this sector
and also examine the current changes in the structure of the industry and the changing behaviour
of firms in responding to the policy changes.
India‟s response to drugs flows along an extraordinary spectrum – of tradition and
modernity; of widespread availability and stringent enforcement; of tolerance and prohibition; of
production for medical use to lack of medical access to opiates. India‟s long history of cannabis
and opium use is referenced extensively in policy analysis. Being a country with significant
volumes of licit and illicit drug cultivation, a transit route as well as a consumer market, India‟s
drug policy dilemmas span „demand‟ and „supply‟ control. Its large chemical and pharmaceutical
industry draws the country into deliberations on the illicit manufacture of drugs and precursor
control as well as the non-medical use of prescription drugs. Some parts of the country report
alarmingly high rates of drug dependence, HIV and viral hepatitis amongst people who inject
drugs, making health and harm reduction important policy considerations. While India‟s harsh
drug control laws (in particular criminalize of drug use and the imposition of the death penalty
for certain drug offenses) conform strictly to prohibition, its regulated opium cultivation industry
provides insights for countries that are experimenting with alternatives to prohibition.

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The Evolution of the Indian Drug and Pharmaceutical Industry
● The history of the evolution of the Indian pharmaceutical industry can be divided on four
epochs. The first epoch is from 1850 to 1945.

● The second epoch is from 1945 to late 1970‟s.

● The third epoch of the development is from the early 1980‟s.

● Last the fourth epoch is from 1990‟s to the present.

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INDIA PHARMACEUTICAL EVOLUTION

Scenario of National Drug Policy
Before the advent of British Rule, the indigenous forms of medicine were in use
(Ayurveda) in India. The Central Government of British India first introduced the Allopathic
form of medicine in the country. However there are no production units in the country. Instead
the foreign companies exported raw materials from India transformed into the finished products
and imported back into India. The establishment of the Bengal Immunity in 1919 by a group of
notable scientists and physicians, namely Bidhan Chandra ray, Kailash Chandra Bose etc. is the
landmark in Indian Pharmaceutical industries. During this period, foreign companies across the
globe as well as Indian companies were engaged in the production of the relative activities and
the importance of R & D were unknown and the new inventions of drugs were made and the
individual effects of the scientists and the drug companies were not engaged in it. Concerned
about the lack of the manufacturing facilities and guided by the perception that foreign

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technology as an important component for the growth of the pharmaceutical sector, the
government of India in its Industrial Policy Statement of 1948 decided to take a liberal attitude
towards MNC‟S and allowed them to establish plants without facing the hurdles of the licensing
authorities.
According, the license granted under the supervision of the Director General of Technical
Development (DGTD) for setting up a new unit or expansion of the existing units keeping into
account the medicinal need for the country. In order to fulfil regulatory requirements many
foreign companies started their production in India. During this period a large number of
domestic companies also entered into the market mainly due to government support under the
Industrial Licensing Act and started producing a wide range of products.
OBJECTIVES OF THE NATIONAL DRUG POICY
Objectives of the policy are:
i. To ensure efficient and effective drug management in the public and private sectors.
ii. To ensure access to safe, effective, affordable and good quality drugs at all levels of health
care based on health needs.
iii. To promote the rational use of drugs by doctor‟s, dispensers and consumers.
iv. To increase local drug manufacture/production and promote export.
v. To ensure that all drugs in the national drug distribution system are safe, efficacious,
effective and of good quality.
vi. To strengthen administrative, legislative, and regulatory controls of the importation,
manufacture, procurement, storage, distribution, supply, sale and use of drugs.
vii. To promote research on herbal remedies and integrate those found to be safe and
efficacious into the health care system.
viii. To promote pharmaceutical research and development of raw materials for the
production, compounding and formulation of pharmaceutical products, as well as operational
research for the effective implementation of the National Drug Policy.
ix. To enlist government commitment at all levels for the achievement of the goals and
objectives of the National Drug Policy.

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STRATEGIES FOR IMPLEMENTING THE NATIONAL DRUGPOLICY
The strategies that shall be used to implement the National Drug Policy shall focus on
effective drug management processes, such as rational drug selection, proper quantification
of drug needs at all levels of health care delivery, and effective procurement practices. Others
shall include assurance of quality of drugs at all levels, appropriate storage, proper costing
and effective distribution of drugs, promotion of local drug manufacture, appropriate
legislation, product registration, research and development, human resources development,
monitoring and evaluation. Furthermore, the strategies shall emphasize proper accountability
and rational use of drugs by health workers and consumers.
In view of the fact that these activities are purely technical, at all levels - federal, state and
local governments, shall be required to employ pharmacists and other relevant personnel to
ensure satisfactory implementation of the policy.

Selection of Drugs
The objective of the drug selection process is to have a national list of drugs which are
rationally chosen to satisfy the health care needs of the majority of the population. Such a list
shall regularly be revised and shall form the basis of drug selection by primary, secondary
and tertiary public health-care institutions. In this regard, the Federal Government shall take
the following steps:
i. A revised Essential Drugs List shall be published by the Federal Ministry of Health and
made available to health professionals, state and local governments, primary, secondary
and tertiary health institutions.

ii. Drugs included on the list shall:
• Be listed using generic or international non-proprietary names.
• Be based on the health needs of the majority of the population.
• Have substantial safety and risk/benefit ratio with sufficient accumulated scientific
data.

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• Be registered by the national drug regulatory authority.
iii. As much as possible, formulations containing more than one active ingredient shall be
avoided, unless one or more of the following criteria are met:
• The clinical condition justifies the use of more than one drug in a fixed combination.
• Two or more pharmacological active pharmaceutical ingredients are synergistic
active in a product.
• Patient‟s compliance is enhanced by the combination.
iv When two or more drugs are therapeutically equivalent or several drugs are available for
the same indication, preference shall be given to products with the:
o Most scientific research and clinical data.
o Most favourable pharmacokinetic properties.
o Best cost advantage.
o Best patient compliance.
o Most stable pharmaceutical dosage form for which appropriate storage facilities
exist.
v The Essential Drugs Review Committee shall update the list every four years.
vi Suggestions for amendment shall be made in writing on a prescribed form to the Federal
Ministry of Health, justifying each suggested amendment. New drugs shall only be added
to the list if sufficient scientific and clinical data are available to show that they offer
distinct advantages over existing ones. Drugs on the list for which information becomes
available that they no longer have a favourable risk/benefit ratio shall be withdrawn and
replaced with safer alternatives.
vii The Essential Drugs List shall be used for:
• The procurement of drugs and their use in the public sector.
• Prescribing drugs in the public sector.
• Drug information to health care providers.

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• The production of Standard Treatment Guidelines and National Formulator
reimbursements on drugs in the National Health Insurance Scheme.

Procurement of Drugs
The procurement process is a major determinant of the safety, efficacy, quality,
affordability and availability of drugs. Its objective is to provide drugs from relevant
information, need and available resources. To address the situation, the following criteria shall
be adhered to:
i Government shall be committed to good pharmaceutical procurement practices in the
public sector.
ii Procurement of drugs shall be restricted to drugs registered in India and on the Essential
Drugs List.
iii Procurement in the public sector shall be by International Non-Proprietary Names (INN) or
generic names only.
iv Procurement at all levels shall be by open, competitive tender and shall be conducted in a
transparent manner with the advice of the Pharmacy Department. To encourage local drug

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manufacture preference shall be given to the purchase of locally manufactured drugs.
v Procurement shall be based on accurate quantification of drug requirements by the
Pharmacy Department.
vi Procurement and receipt procedures shall ensure that drugs supplied are of good quality.
vii In order to keep prices low and undertake adequate quality assessment, drugs, shall as
much as possible, be purchased in bulk.

Drugs procured at all levels shall be subjected to quality assessment before distribution to
dispensing units.

Drug Revolving Fund Scheme
The Drug Revolving Fund Scheme is a very effective strategy for ensuring uninterrupted
drug supply in the health care delivery system. Experience from several health institutions in
the country, however, has shown that its advantages have not been apparent due to a variety of
reasons, including the following:
• Poor management.
• Misapplication of the Fund.
• Purchasing of drugs at exorbitant prices.
• Lumping of the proceeds of the Fund into a general account.
• Non-reimbursement of the cost of drugs for exempted patients.

Consequently, the Drug Revolving Fund Scheme shall be strengthened at all levels of
government through:
❖ Establishment of a DRF committee in every health institution for an effective and
transparent fund management.
❖ Provision of adequate capital for the procurement of required drugs; iii. Maintenance of
a separate account for the DRF scheme, which shall be used exclusively for drug
purchasing.
❖ Ensuring strict accountability for the drugs provided in the system by supplying them on
a “cash-and-carry” basis.

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❖ Empowering the head of the pharmacy department of the health institution as the
custodian of drugs to the institution and making him a required signatory to the DRF
account.
❖ Provision of appropriate training for the DRF personnel.
Pricing Policy
Experience in recent years has shown that drugs have been procured at much higher
prices in public health institutions than in private retail pharmacies. Even within the public
sector, there are wide variations in the prices of the same drugs from one institution to another.
Therefore, to ensure affordability of drugs in public health institutions, government shall
establish necessary mechanisms to guarantee that drug supply to patients shall cost less than in
the private sector.
People and Governments are willing to spend money on drugs for many reasons, so it must be
safe, effective and of good quality and used appropriately. Problems relating to drug safety and
efficacy exist in many places around the world today in developing and developed countries.
This means that development, production, importation, exportation and subsequent distribution
of drugs must be regulated to ensure that they meet prescribed standards. Therefore, effective
drug regulation is required to ensure the safety, efficacy and quality of drugs as well as accuracy
and appropriateness of the drugs.
DRUG PRICE REGULATORY SYSTEM IN INDIA
National Pharmaceutical Pricing Authority (NPPA)
❖ 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 at 1997.
❖ Resolution published in the Gazette of India No.159 dated 29.08.97.
❖ The Resolution mentioned that the Government had been experiencing the present
mechanism for the fixation and revision of prices of bulk drugs and formulations was
cumbersome, complicated and time-consuming.

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❖ In order to streamline and simplify the procedure and to bring about a greater degree of
transparency as well as objectivity, an expert body should be constituted with the powers
to fix prices and notify the changes therein, if any, of bulk drugs and formulations from
time to time, under the Drugs (Price Control) Order.
❖ Powers were delegated to the NPPA by the Govt. of India vide Gazette Notification No.
637 (E) dated 4
th
September, 1997
❖ NPPA is an organization of the Government of India which was established to fix/ revise
the prices of controlled bulk drugs and formulations and to enforce prices and availability
of the medicines in the country, under the Drugs (Prices Control) Order, 1995.
❖ The organization is also entrusted with the task of recovering amounts overcharged by
manufacturers for the controlled drugs from consumers.

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DIFFERENT FORMS INCLUDED: -
▪ FORM- 1:- Application for Fixation/ Revision of Price.
▪ FORM- 2:- Information Related With Price Of Non-Scheduled Bulk Drug.
▪ FORM-3:- Application for Approval/Revision of Price of Formulation.
▪ FORM-4:- Application for Approval/Revision of Price Of Scheduled Formulation
imported in Finished Form.
▪ FORM-5:- Form of Price List.
▪ FORM- 6:- Yearly Information on Turnover and Allocation of Sales and Expenses.
The Amendment of Patent Law and the Implementation of the New Drug Policy
o Concerned by the high phase of medicines and the lack of domestic infrastructure, the
government constituted the Hathi Committee in 1974 to probe into the problems and
suggest a rational drug policy that would meet the medical needs of the country.
o Recommended by the Committee‟s report the government amended the Patent Act of
1970 and enacted the Foreign Exchange Regulation Act (FERA) 1973 in its new drug
policy.
o The Patent Act of 1970 recognized only process patents. The life of the patent was also
reduced significantly from 16 to 5 years from the date of filling a complete application
whichever is shorter in other words; the maximum period of the patent is 7 years.
o Further, in the amended Act an MNC could patent only one process. FERA was
implemented to compel MNCs to manufacture high technology bulk products.
o The corresponding figures of the domestic firms were about 1:10. In addition, the NDP
of 1978 had reservation for the domestic manufacturer for the production of various
categories of drugs.
o The Patent Act of 1970s and the changes in domestic regulation virtually curbed the
monopoly of MNCs.
o The FERA and NDP of 1978 also restricted the activities of MNCs. It is, therefore, not
surprising to find that the share of MNCs dropped from 70% to 50% in late 1980s.
o This was done to encourage the greater participation of private players in the production
of drugs, because the public sector started to suffer from industrial sickness due to lack of
proper commercial orientation.

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The Phase of Liberalization, De-Control and Product Patent
 The growth impetus that the sector received during the 1980s continued even in the
1990s.
 The pharmaceutical sector witnessed a consistent growth of around 16% from 1995
onwards.
 The bulk drug and the formulation sector also experienced a growth rate of between 15%
and 20% during this period.
 Because of the competence gained by the Indian pharmaceutical companies in process
engineering, the Indian companies also emerged as the major players in the domestic
market. This resulted in a further fall in the share of MNCs in the country.
 The country also gained reputation in the international market as low cost producer. The
number of production units in the Indian pharmaceutical sector also increased from 1,752
in 1952-1953 to 20,053 in the year 2000-2001.
 Further, the free import of formulations, bulk drugs and intermediaries are allowed. The
government also implemented certain rules in its New Drug Policy for producers to
follow good manufacturing practices and to produce the quality products.

To recall the Patent Law was amended under the WTO compulsion to recognize product patent
from 2005 onward.
 On January 1, 2000, a Second Amendment was introduced. Its key issues redefined
patent subject matter extended the term of patent protection to 20 years and amended the
compulsory licensing system.
 The Third Amendment of patent law was made on January 1, 2005 to introduce product
patent regimes in areas, including pharmaceuticals that were covered by the patents only.

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FUNCTIONS OF NPPA
⚫ To implement and enforce the provisions of the Drugs (Prices Control) Order in
accordance with the powers delegated to it.
⚫ To deal with all legal matters arising out of the decisions of the Authority.
⚫ To monitor the availability of drugs, identify shortages, if any, and to take remedial steps.
⚫ To collect/ maintain data on production, exports and imports, market share of individual
companies, profitability of companies etc, for bulk drugs and formulations.
⚫ To undertake and/ or sponsor relevant studies in respect of pricing of drugs/
pharmaceuticals.
⚫ To recruit/ appoint the officers and other staff members of the Authority, as per rules and
procedures laid down by the Government.
⚫ To render advice to the Central Government on changes/ revisions in the drug policy.
⚫ To render assistance to the Central Government in the parliamentary matters relating to
the drug pricing.
PROCEDURE FOR PRICE FIXATION / REVISION OF BULK DRUGS
As per par 3 of DPCO, 1995 prices of scheduled bulk drugs are fixed by the NPPA.
Following steps are involved in fixation/revision of bulk drug prices:-
Step1: Identification of bulk drugs
Drug taken up for study based on:-
 Validity period.
 Concerned manufacturer/company.
 Drug produced in the country for which no price has been notified under DPCO, 1995.

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Step 2: Collection of data
Data is collected by issuing questionnaire/Form I of DPCO, 1995/cost-audit report etc. and
verification by plant visits, if required.
Step 3: Preparation of actual cost statement
Prepare on basis of data submitted / collected and verified during plant visit.
Step 4: Preparation of Technical Parameters
Technical parameters are prepared based on data submitted and collected. Plant capacity is
assessed considering 330 working days for normal operation of plant leaving 35 days for
scheduled maintenance of plant. The achievable production level is considered at 90% utilization
of assessed capacity allowing 10% production loss on account of unforeseen break down.
Step 5: Preparation of Estimated Cost
The estimated cost for the pricing period is then prepared based on actual cost & technical
parameters. While projecting the future cost, an increase is recognized at 5% per annual in
respect of salaries & wages. The customs duty and other taxes as per the current budget are
considered.
Step 6: Calculation of Fair price of bulk drug
Fair price is calculated by providing returns as specified in sub Para (2), Para 3 of DPCO, 1995.
Step 7: Fixation of maximum sale price of the drug
When the number of manufacturers of the drug is more than one, the maximum sale price is
fixed at 2/3rd cut off level or weighted average price, depending upon the situation.

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Drug Storage
The objectives of drug storage shall be to ensure stock security and the maintenance of the
quality of drugs throughout their shelf life.
Government shall ensure that suitably located, constructed and equipped storage facilities will be
available at every level of the drug distribution system, in both public and private sectors.
The efficient and successful operation of a drug storage and distribution system requires the
professional skills of pharmacists. Therefore, pharmacists shall be in charge of the drug stores
operated by federal, state and local governments as well as in the private sector.
In addition, the following measures shall be implemented:
i Central Medical Stores and stores in both public and private health care facilities shall be
properly managed to ensure that drugs do not expire or deteriorate on the shelf. However,
any stock of expired or deteriorated drugs shall be officially destroyed within six months.
ii Central Medical Stores shall have Quality Control Laboratories where basic tests shall be
undertaken to determine the quality of drugs received or supplied.
iii Regular checks on the quality of stored drugs shall be undertaken to ensure that they do
not deteriorate under storage conditions.
iv Public and private sector establishments shall put adequate mechanisms in place to ensure
that the temperature in all drug storage facilities is maintained at not more than 20
o
C for
the sustenance of the shelf life of drugs. In respect of vaccines and biological products
they shall provide appropriate cold storage for the maintenance of the shelf life of such
vaccines and products.
v Government at all levels shall ensure the establishment of central computerized inventory
control systems in the central stores for effective drug management.
vi Government shall encourage the computerization of private drug stores for effective
inventory control.

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Drug Distribution
Rational drug distribution channels shall be promoted in both public and private sectors. In this
regard the following measures shall be enforced by the Federal Government:
i Drug distribution, supply, sale and dispensing shall be under the control and supervision of
pharmacists at all levels.
ii Government shall ensure that drug manufacturing, wholesale and retailing activities are
registered as distinct enterprises.
iii The channel for private sector drug distribution shall flow from manufacturers or importers
to wholesalers and retailers.
iv Government shall ensure that drug supplies to public health facilities will be based on
expressed need and, in the main, shall be from the Central Medical Stores.
v Government shall ensure that all drugs purchased or donated to governments at all levels
are channelled through the Central Medical Stores.
vi Government shall establish inventory control systems, including computerization, in all
hospital pharmacies and clinics for effective inventory control. These shall be linked to a
central computerized inventory control system in the Central Medical Stores.
vii Adequate security shall be provided for storage areas, and, in particular, for narcotic drugs.
viii Drugs distributed in the country shall, at least, be labelled in English.
ix Government shall create incentives for pharmacists to establish practices in rural areas in
order to promote rational drug distribution and use. Professional associations and
regulatory bodies involved in health care shall encourage their members to establish
professional practices in rural areas to complement government efforts in promoting
greater access to and rational use of drugs.

Rational Drug Use
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. Rational drug use as an
essential element of a National Drug Policy seeks to avoid the all-too-frequent problems of
under- and over-prescription, inappropriate prescription, and the use of new, expensive drugs

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when equally effective, well-tried, safe and cheaper alternatives are available. Concerted efforts
shall be made by government at all levels to promote rational drug use through.
Education and Training:
The objective is to ensure that all health personnel involved in the diagnosis, prescription and
dispensing of drugs, as well as consumers, receive adequate theoretical and practical training in
rational drug use. It will, therefore, be necessary to take the following initiatives:
i Promote the teaching of the concepts of rational drug use in pharmacy, medical, nursing
and veterinary schools.
ii Training on communication skills in pharmacy, medical, nursing and veterinary schools to
promote rational prescribing and dispensing.
iii Develop educational strategies and programs directed at the public on appropriate use of
drugs.

Rational Prescribing:
The objective is to ensure that drugs are prescribed rationally. Consequently,
➤ Up-to-date Standard Treatment Guidelines and a National Formulary shall be made
available to all doctors according to the level of care.
➤ Prescribing shall be by International Non-Proprietary Names (INN) or generic names.
➤ At health care facilities, diagnostic services appropriate to the level of health provided to
improve the accuracy of diagnosis.

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Rational Dispensing
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:
● Dispensing shall only be carried out on duly licensed premises.
● The minimum information requirement on the label of a dispensed medicine shall be the
following:
i. Name of patient.
ii. Generic name of dispensed drug.
iii. Strength of the drug.
iv. Dosage instruction in symbols or words as may be appropriate.
v. Duration of treatment.
vi. Date of dispensing.
vii. The name of the institution where the drug was dispensed.
viii. The patient shall be counseled on the use of dispensed drugs, in a conducive
environment suitable for effective communication.
ix. Dispensing shall be carried out in a suitable container that will be childproof
and ensure the stability of the drug dispensed.

Drug Information Services
Drug information is intended to provide unbiased, scientifically validated drug information
to promote rational prescribing, dispensing and use. In this respect, therefore, the following
measures shall be taken:
i Drug information units shall be established in all public health institutions.
ii The drug information units/centre‟s shall, always, be suitably equipped and provided with
up-to-date reference materials and equipment, including computers, and internet access, to
guarantee the acquisition and dissemination of current and accurate drug information.

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NATIONAL POLICY FOR NARCOTIC DRUGS
Narcotic Drugs and Psychotropic Substances Act, 1985
India is a party to the three United Nations drug conventions – the 1961 Single Convention on
Narcotic Drugs (1961 Convention), the 1971 Convention on Psychotropic Substances (1971
convention) and the 1988 Convention against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances (1988 convention). Domestic legislation to give effect to these treaties was
introduced only in the 1980s when the „grace period‟ for abolishing non-medical use of
cannabis and opium under the 1961 Convention expired. Exercising its powers to make law for
the country for implementing “any treaty, agreement or convention or decision made at
international conference”, the Indian Parliament passed the Narcotic Drugs and Psychotropic
Substances Act, 1985 (NDPS Act) hastily, without much debate. The NDPS Act came into
force on 14 November 1985, replacing the Opium Acts and the Dangerous Drugs Act. The 1940
Drugs and Cosmetics Act continue to apply.
The official record states that the NDPS Act was enacted in order to provide adequate penalties
for drug trafficking, strengthen enforcement powers, implement international conventions to
which India was a party, and enforce controls over psychotropic substances. The Act was
amended in 1989, 2001 and more recently in 2014.
The NDPS Act prohibits cultivation, production, possession, sale, purchase, trade, import,
export, use and consumption of narcotic drugs and psychotropic substances except for medical
and scientific purposes in accordance with the law. Preparation to commit certain offenses is
punishable as an attempt. Accessory crimes of aiding and abetting and criminal conspiracy
attract the same punishment as the principal offense.
The Act covers three broad classes of substances:
❖ Narcotic drugs, that is, those covered under the 1961 Convention.
❖ Psychotropic substances or those covered under the 1971 Convention as well as other
psychoactive substances such as ketamine which are not yet classified under
international conventions.

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❖ “Controlled substances” that are used to manufacture narcotic drugs or psychotropic
substances, for example precursor chemicals such as acetic anhydride, ephedrine and
pseudoephedrine.
In 1988, the NDPS Act was supplemented by the Prevention of Illicit Traffic in Narcotic Drugs and
Psychotropic Substances Act to provide for preventive detention of people suspected or accused of
involvement in drug trafficking.
NDPS Amendments
Amendments, 1989
In 1989, the NDPS Act underwent the first set of amendments, after a Cabinet Sub-Committee
for combating drug trafficking and abuse recommended that the law be made more stringent.
The „tough on drugs‟ rhetoric led to the introduction of very harsh provisions such as
mandatory minimum sentences of 10 years imprisonment, restrictions on bail, bar on
suspension and commutation of sentences, trial by special courts and mandatory death
sentences for certain repeat offenders. The changes, which came in less than four years after the
law was initially passed, seem to have been influenced by international, regional and domestic
developments – namely, the signing of the 1988 Convention; deliberations at the South Asian
Association for Regional Cooperation (SAARC) on the growing menace of drug trafficking,
increasing political dissent and „terrorist‟ activity in northern states and the perception that
terrorism is backed by drug trafficking.
Following these amendments, people caught with small amounts of drugs faced long prison
sentences and hefty fines; unless they could prove that the drug was intended for personal use
(in that case, the offender would be subjected to six months or one year in prison depending on
the drug). With bleak chances of release on bail, many people arrested for possessing minor
amounts of drugs intended for personal use languished in jail for over 10 years for a few
milligrams of contraband.
Amendments, 2001
Criticism of this harsh and disproportionate sentencing structure created a momentum for
reform. In 1998, the NDPS (Amendment) Bill, was introduced in Parliament and subsequently

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examined by the Parliamentary Standing Committee on Finance. The amendments were finally
adopted in 2001, to grade punishment based on the quantity of drugs involved – that is, “small”,
“commercial” or “intermediate”. Thresholds were specified by the central government through a
notification dated 19 October 2001.
Amendments, 2014
In early 2014, the NDPS Act was amended for the third time and the new provisions came into
force on 1 May 2014. The main features include:
• Creation of a new category of “essential narcotic drugs”, which the central government can
specify and regulate uniformly throughout the country.
• Widening the objective of the law from containing illicit use to also promoting the medical
and scientific use of narcotic drugs and psychotropic substances in keeping with the
principle of „balance‟ between control and availability of narcotic drugs that underpins the
international drug control treaties
• Including the terms “management” of drug dependence and “recognition and approval” of
treatment centre, thus allowing for the establishment of legally binding treatment standards
and evidence-based medical interventions.
• Making the death penalty discretionary for a subsequent offense involving a certain quantity
of drugs under section 31A. The court will have the alternative to impose imprisonment for
30 years under section 31.
• Enhanced punishment for small quantity offenses from a maximum of six months to one
year imprisonment.
• Allowing private sector involvement in the processing of opium and concentrated poppy
straw.
• Raising the rank of officers authorized to conduct search and arrest license holders for
alleged NDPS violations.

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PENALITIES AS PER THE NARCOTIC DRUGS AND PSYCHOTROPIC
SUBSTANCES ACT, 1985
Drug Quantity and punishment
Small
Quantity
Punishment Punishment Quantity
greater than
small but
lesser than
commercial
(Intermediate)
Heroin 5g



Maximum of
1 year
rigorous
imprisonment
or penalty
250g



Rigorous
imprisonment
up to 20
years and
penalty

Opium 25g 2.5kg Imprisonment
extended up
to 10 years
and penalty.
Morphine 5g 250g
Cannabis 1000g 20kg
Cannabis
resin
100g 1kg
Coca leaf 100g 2kg
Cocaine 2g 100g
Methadone 2g 50g
Amphetamine 2g 50g
THC 2g 50g
LSD 0.002g 0.1g

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Key features of the NDPS Act on treatment Section
An „addict‟ is a person who is dependent on any narcotic drug or
psychotropic substance.

2 (a)
Treatment is one of the measures that legislation should take and allocate
the funds.

4 (2) & 7 A
Drug dependent people, who are charged with consumption or an offence
involving a small quantity of drugs can choose to undergo treatment and be
exempt from prosecution

64 A
Instead of sentencing, courts can divert drug dependent people convicted
for consumption or an offence involving a small quantity of drugs, to a
recognized medical facility for detoxification, instead of sentencing.

39
The government can set up and regulate centres for the identification,
treatment and care of drug dependent people.
71, 76 (2) (f)
&
78 (2)(b)

KEY FACTORS IN UTILIZATION OF NATIONAL DRUG POLICY IN INDIA
The Indian Pharmaceuticals Industry, particularly, has been the front runner in a wide range of
specialties involving complex drugs manufacture, development and technology. With the
advantage of being a highly organized sector, the pharmaceutical companies in India are growing
at the rate of 4.5 billion dollars, registering further growth of 8-9% annually. More than 20,000
registered units are fragmented across the country and reports say that 250 leading Indian
Pharmaceutical companies control 70% of the market share with stark price competition and
government price regulations because of its Competent Workforce, Cost – Effective Chemical
Synthesis and Globalization.

Monitoring and Evaluation of National Drug Policy
The success of the National Drug Policy would depend on how well its provisions are
implemented. Mechanisms shall, therefore, be put in place for monitoring, measuring and

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evaluating the Policy‟s performance and impact, and for identifying possible problems and
evolving effective strategies to address them.
In this regard government shall ensure:
i. The setting up of a National Drug Policy Monitoring and Evaluation Unit in the Federal
Ministry of Health, to measure progress in the implementation of the policy and to run a
national evaluation scheme.
ii. Compilation of indicators for monitoring the National Drug Policy as an integral part of the
National Health Information System, and evaluating these indicators at all levels of health
care at the local, state and federal governments.
iii. Institutionalizing of drug management information systems is based for deriving drug
management and other relevant information for taking decisions on the National Drug
Policy.
iv. Close monitoring of the effects of international trade agreements on India access to
essential drugs.

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References
o National Drug Policy published by the Federal Ministry of Health in collaboration with the
World Health Organization.
o International Drug Policy Consortium by Tripti Tandon, Deputy Director, Lawyers.
o A rational drug policy by P K SARKAR Editor, Bulletin on Drug and Health Information
(BODHI), 254, Block B, Lake Town, Kolkata 700089, India. e-mail: [email protected].
o www. wikipedia .org/national drug policy in India.
o www. usfda.org.
o A Treatise on Pharmaceutical Regulatory Affairs & Quality Management by Dr. D R Varun,
volii (461-72).www.slideshare.com/national drug policy in India.
o www.authorsstream.com/national drug policy in India.
o http://www.medindia.net/buy_n_sell/pharm_industry/ph_drugpolicy.asp.
o http://apps.who.int/medicinedocs/pdf/s2283e/s2283e.pdf
o http://www.aidsdatahub.org/sites/default/files/documents/Drug_Policy_in_India_
o 2005.pdf.pdf
o http://www.who.int/bulletin/volumes/92/2/13-121558/en/
o http://apps.who.int/iris/bitstream/10665/66250/1/WHO_EDM_2000.2.pdf