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Showing posts from March, 2018
Regulations & Guidelines



we understand the problems faced by pharma professionals in accessing requisite information in order to comply with the regulatory requirements at home and in the regulated foreign markets. We’ve tried to simplify things for you by assembling the important Indian and international guidelines and regulations in this section. Indian Regulations & Guidelines: CDSCO-Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India provides general information about drug regulatory requirements in India. NPPA-Drugs (Price Control) Order 1995 and other orders enforced by National Pharmaceutical Pricing Authority (NPPA), Government of India. D & C Act, 1940-The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India. Schedule M-Schedule Mof the D&C Act specifies the general and specific requirements for factory premises and materials, plant and equi…