Moving forward with desires and despair

As we move into the new year I wish all my readers a very Happy and Prosperous New Year. I also thank you all for visiting my blog and giving valuable comments and suggestions throughout this year.
When we move into a new year, it seems nothing new is happening. May be this is the sign of my growing age which has seen 35 springs and therefore 'New Year' really do not appear new !!
Or may be the year went by was so chaotic that it condensed the enthusiasm of life.
If I recall some of the major headlines which remained in the news in 2008 from Pharma world then it would be :

• Continuing of Heparin case investigations and afterfall.
• Ranbaxy banned for Exporting 28 drug products from their 2 plants after FDA served Warning Letters.
• Ranbaxy acquired by Daiichi Sankyo of Japan.
• Melamine identified in Chinese dairy products.

I wish the coming year comes with lots of good news.

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