Saturday, December 13, 2008

Better Late than Never - GLP on board

Announcement to ammend the Drugs & Cosmetics Act to include Schedule L-I of Rules 74, 78 and 150 E (Third Amendment Rules 2008) giving the pharmaceutical industry time till November 1, 2010 for compliance of Good Laboratory Practices. 

This comes at least 20 years after the last ammendmend made into the US rules in 1987 as 21 CFR part 58 which came into effect in 1979.

Better Late than Never for India.

Under the notification of the Ministry of Health and Family Welfare, Department of Health, No G.S.R.634(E), sections 12 and 33 of the D&C Act, has now inserted 'Good Laboratory Practices' as in Schedule L-I and in Rule 78, in clause (p), and in Rule 150 E, in clause (a). 

With Schedule L-I of Rules 74, 78 and 150 E, all pharmaceutical companies will need to adhere to Good Laboratory Practices (GLP) and have the necessary requirement of premises and equipment. Pharma companies need to speed up to upgrade the systems and there is a need for comprehensive technical sessions on similar lines like Schedule M to create massive awareness on the importance of the compliance.

The news is published in Pharmabiz and can be read here

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