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The Government has amended the Good Manufacturing Practices outlined in Schedule M to the Drugs and Cosmetics Rules vide Gazette Notification GSR 431 (E) dated 30.06.2005. The amendment has been made based on the comments received on draft rules which were issued vide Gazette Notification GSR 738 (E) dated 08.11.2004.
Under the amended rules, the ancillary areas earlier provided as requirements for plant and equipment for manufacture of majority of formulations have been deleted. Certain changes in the Air Handling System have also been made apart from certain other minor changes to stream line the requirements. The State Licensing Authorities have been given discretionary powers to modify the requirements in respect of certain categories of drugs if they are satisfied that it is necessary to relax or alter the conditions in the particular case which may be recorded in writing. The provisions of the revised Schedule will now be applicable to all the manufacturers from 01.07.2005.
The text of the Notification is available on the website www.cdsco.nic.in .
Good Manufacturing Practices are integral part of production of drugs to ensure consistency in their quality. These requirements had been prescribed under Schedule M to the Drugs & Cosmetics Rules. In order to keep pace with changing requirements in the techniques of manufacture and to bring more clarity in the records of manufacture and in-house controls maintained by the manufacturers, the Schedule M was amended by the Gazette Notification GSR 894 (E) dated 11.12.2001. The National Human Rights Commission in its order in 1999 had also desired that Schedule M should be revised to conform to WHO and International Standards. A time limit of 2 years was provided in the year 2001 for the implementation of the provisions of revised Schedule M for the then existing manufacturers. A further extension for another 1 year and then another 6 months i.e. upto 30.06.2005 was further granted to the existing manufacturers on their request for making provisions for implementations of revised Schedule M.
New Delhi, Sravana 20, 1927; August 11, 2005 Ministry of Health and Family Welfare’s I.D. No.X.11014/7/2003-DMS&PFA
EK/MK.
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