Utter confusion prevails in the country over the issue of granting or renewal of manufacturing licences of drug formulations under brand names by the state drug licensing authorities for the purpose of exporting.
While the senior health ministry officials have since been maintaining that the ministry's recent directions to the state drug licensing authorities to grant or renew drug licences in proper generic names only will not be applicable to the exporters in the country, the state drug licensing authorities have more or less stopped issuing licenses in brand names, leaving the exporters literally in the lurch.
According to industry sources, ever since the union health ministry issued directions in early October this year to all the states and union territories to instruct their respective drug licensing authorities to grant or renew licences to manufacture for sale or for distribution of drugs in proper generic names only, the SLAs have started issuing the licences in proper generic names only. They are not issuing licences in brand names even for exports, citing reasons that there is no written directive from the ministry in that regard.
Earlier, allaying the fears of the exporters, senior health ministry officials including the DCGI have been maintaining that the ministry's directive will not have any adverse impact on the pharma exporters in the country. They had said that ministry's recent direction, issued under Section 33 (P) of Drugs & Cosmetics (D&C) Act, will not be applicable to the exporters.
But, there is still confusion among the industry and the state drug licensing authorities as the health ministry did not come up with a written clarification in this regard so far. Without any written clarification, the SLAs are refusing to the exporters to issue licences in brand names which is creating a piquant situation for the exporters as they would not be able to market their products in established brand names over the years. They may not also be in a position to launch new products with brand names as drug registrations by overseas authorities would be based on drug licenses granted by Indian authorities.