The Andhra Pradesh Director Control Authority (APDCA) has so far refused to follow union health ministry's recent direction, issued under Section 33 (P) of the Drugs and Cosmetics Act, on issuing drug licenses in generic names only.

“As of now we are continuing the same old process of licensing. We are waiting for a final decision of the DCGI as the issue is still being discussed at the central level. Once the bill is passed in the parliament we may start giving the licenses in generic names, till then we will continue with the old procedure,” said R P Thakur, Andhra Pradesh Director General of Drug Control Authority.

He informed that the state DCA is conducting a series of meetings with various drug control officials and association of pharmaceutical manufacturers in the state to finally decide on the status of licensing of drugs in generic names.   It is believed that many drug control officials and pharma manufacturing associations in the state have expressed their concerns and opposed the health ministry’s proposal as the decision will grossly affect the pharmaceutical business in the state.

Talking to Pharmabiz, Thakur, said, “Very soon we will be taking a final decision on the issue. As we have conducted a series of meetings with various stakeholders and drug controllers we are initially planning to issue licenses to only single brand components and for products with multibrand will issue licenses in generic names.”

In early October this year, the union health ministry had issued a direction under Section 33(P) of the Drugs and Cosmetics Act in which the ministry had directed the drug licensing authorities in the states and union territories that henceforth grant or renewal of manufacturing licenses of drug formulations should be in proper/generic names only.  As per the Drugs and Cosmetics Act, the drug licensing authorities in the states and union territories are legally bound to follow any directive issued under under Section 33(P).