The confusion over the Union health ministry's recent directions to the state drug licensing authorities to grant or renew drug licences in proper generic names only is finally over. It has been finally clarified that the approval for drugs will henceforth be granted by the drug authorities only under generic names and the manufacturer can manufacture the product under various brand names.
Though persistent efforts to contact drug controller general of India (DCGI) Dr G N Singh for a clarification on the issue did not bear fruit, senior drug officials said that there is no ban on the use of brand names and the manufacturers can continue to affix their own brand names after getting the approval for their drugs in generic names from the state licensing authorities (SLAs). But, the brand names will not have the approval from the SLAs.
Presently, at the time of grant of the licence for manufacture of a drug formulation, the trade name as submitted by the manufacturer is also endorsed by the SLAs along with the generic name of the product thereby giving legitimacy to market the drug under the brand or the trade name. In fact, brand name issue is a trade mark issue over which the SLAs have no control but they were providing some legitimacy till now even when the trade mark or brand name was clashing with another name.
The manufacturer was always responsible for trade mark but now, after the ministry's directive, the SLAs will stay clear of any involvement in it. Now, the manufacturers only have to intimate the various brand names under which they will be manufacturing the drugs.
The health ministry had recently issued a directive, under Section 33 (P) of Drugs and Cosmetics (D&C) Act, 1940, to health secretaries of all states and union territories in which the ministry had directed that henceforth grant or renewal of manufacturing licences of drug formulations should be in proper/generic names only. The directive, which is mandatory to be followed as it is issued under Section 33 (P) of D&C Act, had created confusion among the manufacturers over the use of brand names.