Good Manufacturing Practices (GMP) and Requirements of Premises, Plant and Equipment for pharmaceutical products laid down in Schedule M of the Drugs and Cosmetics Rules, 1945 prescribe the requirements for disposal of waste including the rejected drugs. Details are as under:
One of the conditions of drugmanufacturing license granted under the Drugs and Cosmetics Rules, 1940 is that the Licensees shall comply with the Good Manufacturing Practices (GMP) requirements prescribed in Schedule M of the said Rules. State Licensing Authorities appointed by the respective State Governments are empowered to take action in case of any violation of above requirements.
The Government has taken various regulatory measures to curb the misuse of antibiotics. However, no report/incidence of growing of anti-microbial resistance of drugs due to discharge of drugs and chemicals into environment has been brought to notice of this Ministry.
The Minister of State (Health and Family Welfare), ShAshwini Kumar Choubey stated this in a written reply in the RajyaSabha here today.
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MV/LK