Mashelkar Panel calls for central licensing for drug manufacture

Ananth Iyer - Mumbai

The 14-member Expert Committee, constituted by the Health ministry and chaired by Dr R A Mashelkar to examine drug regulatory issues including the problem of spurious drugs, has called for centralisation of the issuance of manufacturing licence for drugs and pharmaceuticals, it is learnt. At present, state drug control departments or the state food and drug administrations are the licensing authorities.

At its first meeting held in Delhi on 21 March 2003, the Committee agreed on the need to have a certain degree of uniformity in regulations for issuing manufacturing licences, informed sources told Express Pharma Pulse.

The Committee has formed two groups - one comprising industry representatives and the other of drug control officers - to examine this proposal and come out with final recommendations, it is learnt.

Besides uniformity, the Committee believes that a central licensing authority might also help in tackling the issue of irrational combinations. It is alleged that the standards and controls vary in each state and this is the root cause for the spread of irrational combinations in the market place.

Meanwhile, the drug industry has responded favourably to the proposal. The only concern is the manpower and infrastructure, which the industry feels needs to be strengthened if licensing is to be centralized. “We support the Mashelkar Committee proposal provided zonal and regional offices are set up with adequate manpower support,” Yogin Majmudar, president of Indian Drug Manufacturer’s Association said. “OPPI has no problems as long as sufficient infrastructure support is created for effective implementation,” Dr Ajit Dangi, director general, OPPI said.