After three months of the product patents regime, the much-awaited Indian Pharmacopoeia commission may finally become operational in the coming weeks.
It will play a crucial role in setting standards for safety and efficacy of drugs -- a function presently being performed by the state drug controllers. It will also make available the monographs of patented drugs once the patent expires.
The formation of IP Commission was one of the major projects of the World Bank-assisted Capacity Building Programme for Food and Drugs sector.
Pharmacopoeias in the US and Britain are autonomous bodies, but the IP will be function under the Ministry of Health. The health secretary will be the chairman, while Central India Pharmacopoeia Laboratory director will be the chief scientific director.
The government had earlier earmarked Rs 13 crore for setting up the commission. But it continued to be non-operational for a long time after its formation due to several procedural delays. CIPL, Ghaziabad that will develop the IP commission standards will be the focal point of the new commission.
According to industry experts, the setting up of the commission is an attempt to bring the state drug controllers under DGCI."This is not going to be an easy task. It may, however, be feasible if the government sets up a centralised regulator called the Central Drug Administration recommended by the Mashelkar Committee in its recent report," an industry expert said.