Your client wants to setup a unit in Pharmaceuticals sector in the state of Telangana. Describe in detail about the specific laws applicable for setting up of a unit in the Pharmaceuticals sector.
CS Professional · Secretarial Audit, Compliance Management and Due Diligence · PYQS · December 2019
Your client wants to setup a unit in Pharmaceuticals sector in the state of Telangana. Describe in detail about the specific laws applicable for setting up of a unit in the Pharmaceuticals sector.
Answer & Explanation:
Illustrative list of the Laws applicable to the Pharmaceuticals sector is as under The Drugs and Cosmetics Act, 1940 & Amendment 2008 The Drugs and Cosmetics Rules, 1945 The Pharmacy Act, 1948 The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 Drugs (Magic Remedies) Objectionable Advertisement Rules, 1955 The Narcotic Drugs and Psychotropic Substances Act, 1985 Special Permits and Licences Rules, 1952 The Medicinal and Toilet Preparations (Excise Duties) Act, 1956 The Drugs (Prices Control) Order 1995 (under the Essential Commodities Act) Essential Commodities Act, 1955 The Clinical Establishments (Registration and Regulation) ACT, 2010 The Clinical Establishments (Registration and Regulation) Rules, 2010 Biological Diversity Act, 2002 Biological Diversity Rules, 2004 Drug Policy, 2002 Plant Quarantine Order National Pharmaceutical Policy, 2012 Drugs (Prices Control) Order, 2013 Rules for the Manufacture/ Use/ Import/ Export and Storage of Hazardous micro-organisms/ genetically engineered organisms or cells.
Topics: Compliance Management
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