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Health Ministry not in favour of centralized drug licensing as industry opposes move
CH Unnikrishnan, Kolkata | Wednesday, December 8, 2004, 08:00 Hrs  [IST]

The union health ministry may reject the proposal for a centralized licensing system for drug manufacturing in the country. Mashelkar committee had made a recommendation in this regard for streamlining Indian regulatory system and to eliminate the menace of spurious drugs.

The union health minister Dr Anpumani Ramdoss, while talking to Pharmabiz in Kolkata on the sidelines of 56th IPC, said that the ministry had been receiving hundreds of complaints and opposing views on this recommendation. The majority of these negative views are from the industry. "This large opposition from the industry cannot be ignored while taking a decision on the same," said the minister.

At the same time, the ministry is aware of the lacunae of the existing state level licensing system wherein the drug manufacturers can obtain license from any of the state for manufacturing products that could be sold across the country, he said.

However, the minister informed that his department was working very seriously to find a practical solution to this problem soon. The minister also said that it would be impossible with the existing infrastructure of the central drug regulatory departments to handle a centralized licensing system for drug manufacturing.

But, when asked about his suggestions for improving the drug control infrastructure at the central level, the minister did not make any specific comments despite a World Bank assistance had been availed by the union health ministry for the purpose.

It may be recalled that the All India Drug Controllers Officers Association (AIDCOC) has been opposing the Mashelkar Committee recommendation on the centralized licensing of drug manufacturing as it is not suitable in a country like India where the present infrastructure of the Central Drugs Standards Control Organisation (CDSCO) is not ideal for handling the additional responsibility, instead, the state level departments are more familiar with the regional manufacturers and their issues.

The industry has also been complaining that the centralized licensing would create more chaos than solution, as it will become so inconvenient for the units to approach central authority for each and every licensing need.

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