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

2. INTRODUCTION Drugs play an important role in the health of both peopleand the economy of a country People and Governments willing to spend money on drugsfor many reasons so, it must be safe, effective and of goodquality and used appropriately. Problems relating to drugsafety and efficacy exist in many places around the worldtoday in developing and developed countries . This means, thatdevelopment, production, importation, exportation andsubsequent distribution of drugs must be regulated toensure that they meet prescribed standards.Therefore, effective drug regulation is required to ensurethe safety, efficacy and quality of drugs as well as accuracyand 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 governedby both Centre and State Governments under the Drugs &Cosmetics Act, 1940. MAIN BODIES CENTRAL DRUG STANDARD CONTROLORGANIZATION (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 ANDFERTILIZER DEPARTMENT OF PHARMACEUITICALORGANIZATION AND STRUCTURE. NATIONAL PHARMACEUTICAL PRICING AUTHORITY(NPPA) ACTIVITIES AND RESPONSIBILITIES: All matters relating to NPPA including its functions of pricecontrol and monitoring. Responsible for development of infrastructure, manpower andskills for the pharmaceutical sector. Work for the promotion and coordination of basic, applied andother research in areas related to the pharmaceutical sector andfor international co-operation in pharmaceutical research. 6. NATIONAL PHARMACEUTICAL PRICINGAUTHORITY (NPPA) The National Pharmaceutical Pricing Authority (NPPA), anindependent body of experts in the Ministry of Chemicalsand Fertilizers was formed by the Govt. of India at 1997. Resolution published in the Gazette of India No.159 dated29.08.97. The Resolution mentioned that the Government had beenexperiencing that the present mechanism for the fixationand revision of prices of bulk drugs and formulations wascumbersome, complicated and time consuming. 7. In order to streamline and simplify the procedure and tobring about a greater degree of transparency as well asobjectivity, an expert body should be constituted with thepowers to fix prices and notify the changes therein, ifany, of bulk drugs and formulations from time totime, under the Drugs (Price Control) Order. Powers were delegated to the NPPA by the Govt. of Indiavide Gazette Notification No. 637(E) dated 4thSeptember, 1997 NPPA is an organization of the Government of India whichwas established to fix/ revise the prices of controlled bulkdrugs and formulations and to enforce 8. prices and availability of the medicines in thecountry, under the Drugs (Prices Control) Order, 1995. The organization is also entrusted with the task ofrecovering amounts overcharged by manufacturers for thecontrolled 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-scheduledForm-V examinationInclusion / Exclusion of drugs under DPCO,1995R&D aspectsPharma 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 powersdelegated to it. To deal with all legal matters arising out of the decisions ofthe Authority; To monitor the availability of drugs, identify shortages, ifany, and to take remedial steps; To collect/ maintain data on production, exports andimports, market share of individual companies, profitabilityof companies etc, for bulk drugs and formulations; 13. To undertake and/ or sponsor relevant studies in respect ofpricing of drugs/ pharmaceuticals; To recruit/ appoint the officers and other staff members ofthe Authority, as per rules and procedures laid down by theGovernment; To render advice to the Central Government on changes/revisions in the drug policy; To render assistance to the Central Government in theparliamentary matters relating to the drug pricing.