NATIONAL PHARMACEUTICALPRICING AUTHORITY (NPPA) Department of Pharmaceutical sciences, Maharshi Dayanand University ,Rohtak
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.
The drug regulation consists 1. Drug Laws 2. Drug Regulatory Agencies 3. Drug Regulatory Boards 4. Quality Control 5. Drug Information Centers etc.
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.
MINISTRY OF CHEMICAL ANDFERTILIZER 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.
NATIONAL PHARMACEUTICAL PRICINGAUTHORITY (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.
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
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.
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)
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
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
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.