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Government of India, Ministry of Health & Family Welfare have published a Gazette Notification to amend Schedule ‘M’ to the Drugs and Cosmetics Rules pertaining to Good Manufacturing Practices (GMPs) and requirements of premises, plant and equipments to be followed by the drug manufacturers, for comments from the public within 30 days of the publication of the Gazette Notification. The objection or suggestion, if any, may be addressed to the Secretary (Health), Ministry of Health & Family Welfare, government of India, Nirman Bhawan, New Delhi.
Schedule ‘M’ was earlier amended vide Gazetted Notification GSR 894 (E) dated 11th December, 2001 prescribing detailed guidelines for requirements for production of different pharmaceuticals for maintenance of quality control in the production of drugs through appropriate methodology, assistance procedures and documentation. The requirements of plant and equipments and the minimum areas of premises were also specified. The manufacturers units licensed prior to December, 2001 were given an exemption for two years i.e. up to 31st December, 2003 for incorporating the provisions of new schedule ‘M’. On the basis of representations received, especially from drug manufacturing units belonging to small scale sector, the Government of India had extended the exemption for the then existing units up to 31st December, 2004.
The text of the notification is available at the web-site www.health.nic.in of the Ministry of Health & Family Welfare.
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