Monday, December 24, 2007

AIDCOC objects proposal to establish CDAFriday

www.pharmabiz.com
November 23, 2007 08:00 IST
Sandeep Dubey, New DelhiThe All India Drugs Control Officer's Confederation has expressed its serious objection to the health ministry's move to establish a Central Drug Authority in a bid to streamline drug licensing in the country. Speaking on the issue, S W Deshpande, director general of AIDCOC, said that the proposal to establish Central Drug Authority was inconsistent with the Pharmaceutical Policy draft of 2002. He said that the recommendations of Dr Mashelker Committee have made it clear that establishing an additional authority would not be a solution to the problems of spurious and counterfeit drugs. He said, "Though, we are accepting the recommendations of Dr Mashelker Committee, the government has kept it aside. Now the bill proposed by the Central government does not address issues like strengthening of the drug control administrations at the central and state levels."According to him, since manufacture, sale and distribution are a composite activity, it is necessary to build a single comprehensive agency to monitor their activities. Whereas, the proposed bill envisages two different licensing authorities in the country. The CDA is supposed to regulate manufacturing licences while state drug authorities for issuing trade licenses.A situation like this will pose difficulties for state drugs control officers while investigating cases of sub-standard and spurious drugs. The state drug control officials will not have powers to inspect the manufacturing establishments in the new system. President of AIDCOC Ravi Kant said "With the Centre's move, the State governments, responsible for ensuring availability of standard quality medicines and safe blood to the people in state, will loose all controls over the manufacturers of medicines and also blood banks." He said that the scheme under the food safety and standards Act, 2006 was ideal in the context of country's federal structure and considering division of legislative powers of the Central and State governments. Therefore, if the Union government is serious about the formation of CDA, a body on the lines of National Food and Slandered Authority should be established.

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