1. NATIONAL PHARMACEUTICAL
PRICING AUTHORITY (NPPA)
Department of Pharmaceutical sciences,
Maharshi Dayanand University ,Rohtak

2. INTRODUCTION
 Drugs play an important role in the health of both people
and the economy of a country
 People and Governments 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.

3. The drug regulation consists
 1. Drug Laws
 2. Drug Regulatory Agencies
 3. Drug Regulatory Boards
 4. Quality Control
 5. Drug Information Centers etc.

4. DRUG REGULATORY SYSTEM IN INDIA
 DRUGS REGULATORY SYSTEM IN INDIA is governed
by both Centre and State Governments under the Drugs &
Cosmetics Act, 1940.
 MAIN BODIES
 CENTRAL DRUG STANDARD CONTROL
ORGANIZATION (CDSCO)
 MINISTRY OF HEALTH AND FAMILY WELFARE
 INDIAN COUNCIL OF MEDICAL RESEARCH
(ICMR)
 MINISTRY OF CHEMICAL AND FERTILIZER
 MINISTRY OF SCIENCE AND TECHNOLOGY
 MINISTRY OF COMMERCE.

5. MINISTRY OF CHEMICAL AND
FERTILIZER
 DEPARTMENT OF PHARMACEUITICAL
ORGANIZATION AND STRUCTURE.
 NATIONAL PHARMACEUTICAL PRICING AUTHORITY
(NPPA)
 ACTIVITIES AND RESPONSIBILITIES:
 All matters relating to NPPA including its functions of price
control and monitoring.
 Responsible for development of infrastructure, manpower and
skills for the pharmaceutical sector.
 Work for the promotion and coordination of basic, applied and
other research in areas related to the pharmaceutical sector and
for international co-operation in pharmaceutical research.

6. 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 that the present mechanism for the fixation
and revision of prices of bulk drugs and formulations was
cumbersome, complicated and time consuming.

7.  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 4th
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

8. 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 the consumers.

9. ORGANIZATION
 Chairman
 Member Secretary
 Advisor (Pricing)
 Bulk Drug Pricing
 Form-I,II & VI Examination
 Policy Matters
 Customs / Excise Issue
 Right to Information Bill
 Director (Formulation Division)
 Formulations Pricing
 (Form III & IV)

10.  Availability / Shortage of bulk drugs/formulations
 Production & Import/Export of drugs & formulations
 Parliament Questions / Assurance & VIP ref.
 Director (Monitoring & Enforcement Division)
 Monitoring & Enforcement of prices of bulk drugs &
formulations, both Scheduled and non-scheduled
 Form-V examination
 Inclusion / Exclusion of drugs under DPCO,1995
 R&D aspects
 Pharma Index

11.  Director (Legal Division)
 Identified cases of overcharging on bulk drugs &
formulations and related issues.
 Legal matters & follow up of the pending court cases.
 Any other references on the above
 Director (Admin Division)
 Establishment
 General Admn.
 Co-ordination
 Vigilance

12. 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;

13.  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.