PHARMA REGULATORY AUTHORITIES & ACTS REGULATING PHARMA IN INDIA
The Drugs and Cosmetics Act, 1940: The import, manufacture, distribution and sale of drugs in India are regulated by this act.
The Pharmacy Act, 1948: Central Government constitutes a Central Pharmacy Council of India and the State Governments constitute State Pharmacy Councils.
The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954: This Act controls the ads with respect to drugs and denies the publicizing of cures claimed to have magical effects.
The Medicinal and Toilet Preparations (Excise Duties) Act, 1956: Provides the levy and collection of duties of excise on medicinal and toilet preparations.
The Narcotic Drugs and Psychotropic Substances Act, 1985: This act concerns with the control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances.
The Drugs Price Control Order (DPCO), 1995: Issued under the Essential Commodities Act, 1955 to regulate the prices of drugs. National Pharmaceutical Pricing Authority (NPPA) is empowered to implement provisions of DPCO.
Good Clinical Practice (GCP) Guidelines: GCP guidelines are essentially based on Declaration of Helsinki, WHO guidelines and ICH requirements for good clinical practice. It concerns with draft guidelines for research in human subjects.
The following laws also govern the manufacture, distribution and sale of pharmaceutical products in India:
- The Industries (Development and Regulation) Act, 1951
- The Trade and Merchandise Marks Act, 1958
- The Indian Patent and Design Act, 1970
- Factories Act
- The Ministry of Health & Family Welfare (MoHFW)
- The Ministry of Chemicals and Fertilizers (MoC&F)
Ministry of Health & Family Welfare (MoHFW):
Department of Health: The following are the main agencies of the department which deal with key issues including drug approvals:
- Central Drugs Standard Control Organisation (CDSCO): Works at both Central and State levels and responsible for ensuring safety, efficacy and quality of drugs supplied to the public. Functions with the Drugs Controller General of India (DCGI) as the executive head.
- Drugs Controller General of India (DCGI): The DCGI governs issues such as product approval and standards, clinical trials, introduction of new drugs, import licenses for new drugs and enforcing new drug legislation.
Ministry of Chemicals and Fertilisers (MoC&F):
Department of Chemicals & Petro-Chemicals: Formulates and implements policies and programmes to achieve growth and development of pharmaceuticals in the country.
National Pharmaceutical Pricing Authority (NPPA): It has been entrusted with the task of fixation / revision of prices of bulk drugs and formulations, enforcement of provisions of the Drugs (Prices Control) Order and monitoring the prices of controlled and decontrolled drugs in the country.
- At the State level, the State Food and Drug Administration’s (FDAs) monitor the drug manufacture, sale, and testing by companies in their jurisdiction.
The domestic pharmaceutical industry is represented by the following three main pharmaceutical associations:
Organization of Pharmaceutical Producers of India (OPPI): OPPI, established in 1965, is a platform of multinational drug companies operating in India. It represents the research-based pharmaceutical companies in India.
Indian Drug Manufacturers’ Association (IDMA): Indian Drug Manufacturers’ Association (IDMA) was formed in 1961 & represents domestic manufacturers.
Indian Pharmaceutical Association (IPA): This is the premier professional association of pharmacists in India.
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