Reiterating his stand on issuance of manufacturing licences only in generic names, the drugs controller general of India (DCGI) Dr G N Singh said that the grant or renewal of licences will be done only in generic names, but the manufacturers can receive trade names from the patent office for their brands.
“The exporters of branded pharmaceutical products can apply for any trade name from the offices of Controller of Patents and Trade-marks and the drug control offices will issue licences only in the generic name. The union government has a generic approach. It is going to push generic medicines solely for the benefit of the people. So there is no compromise on our part,” he said categorically.
In October this year, the union health ministry had issued directions to all the states and union territories to instruct their respective drug licensing authorities to grant or renew licenses to manufacture for sale or for distribution of drugs in proper generic names only. In the directive, issued under Section 33 (P) of Drugs & Cosmetics (D&C) Act 1940 to health secretaries of all states and union territories, the ministry directed that henceforth grant or renewal of manufacturing licenses of drug formulations should be in proper/generic names only.
The ministry's directive came in the wake of reports that at the time of grant of the license for manufacture of a drug formulation, the trade name as submitted by the manufacturer was also endorsed by the licensing authority along with proper name of the product thereby giving legitimacy to market the drug under the brand or the trade name.
The directive was strongly objected by the manufacturers and exporters because the order had affected their business dealings with other countries.
But following complaints from manufacturers and the intervention of Pharmexcil, the office of the DCGI clarified that the manufacturers could market and use brand names of their products even though they were granted licences only in generic names.
He said the government is concerned about the quality of the drugs manufactured and sold in the country. An effective watch on spurious drugs and strict implementation of D&C Act are the main concerns of the government now. Government is committed to do all regulatory measures to implement the act properly, Dr Singh said.