To build data bank, Cen­tre asks pharma cos for details

The Times of India (New Delhi edition) - - TIMES NATION - Sushmi.Dey@

New Delhi: In a ma­jor reg­u­la­tory move to col­lect data about the Rs 1lakh crore drug mar­ket in India, the health min­istry has made it manda­tory for com­pa­nies to dis­close de­tailed in­for­ma­tion about their op­er­a­tions, prod­ucts, pro­duc­tion and sales among other things.

In a gazette no­ti­fi­ca­tion pub­lished this week, the gov­ern­ment said phar­ma­ceu­ti­cal com­pa­nies will have to sub­mit these details to the Drugs Con­troller Gen­eral of India in three months. The health min­istry has pro­posed changes to the Drugs and Cos­met­ics Rules, 1945 to make this pro­vi­sion manda­tory, an of­fi­cial said.

“Any non-com­pli­ance to this rule will be treated as vi­o­la­tion of the Drugs and Cos­met­ics Act and will at­tract pe­nal ac­tion,” the of­fi­cial told TOI. The move as­sumes sig­nif­i­cance as the In­dian drug mar­ket is highly frag­mented and there is a dearth of data. While in­dus­try ex­ec­u­tives roughly es­ti­mate around 6000-8000 fa­cil­i­ties in­clud­ing small, big and medium size play­ers op­er­at­ing in the coun­try, there are no fig­ures avail­able for prod­ucts.

In the ab­sence of any authen­tic data, the gov­ern­ment of­ten fails to mon­i­tor com­pli­ance and en­force law and many un­ap­proved prod­ucts con­tinue to throng the mar­ket. The data re­ceived from com­pa­nies will act as ref­er­ence point for drug in­spec­tors and state reg­u­la­tory au­thor­i­ties who can use it for in­spec­tions, au­dits and grant­ing ap­provals.

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