Usha Sharma – Mumbai
In a follow up to the recent directive by the Ministry of Health and Family Welfare specifying that Drug Controllers are mandated to issue licenses for manufacturing solely for generic names of drugs and not on brand names, Pharmexcil officials claim that Ministry officials have lent a sympathetic ear to their concerns.
The industry body in charge of facilitating pharma exports is expecting a notification from the Ministry which will clarify matters in their favour, no doubt giving relief to pharma exporters. The official final notification from the Ministry is expected within a week. It is assumed that the Health Ministry will advise State Drug Controllers to take appropriate action on this issue.
Pharmexcil officials, senior officials from the Ministry of Health and Family Welfare and DCGI had a closed door meeting last Friday, November 2 wherein they concluded that not having the manufacturing license in the brand name will have no adverse effect on pharma exports.
In an exclusively interaction with Express Pharma, Dr PV Appaji, Director General of Pharmexcil said, “We are very grateful to the Ministry of Health and Family Welfare for addressing the queries raised by us. We have raised our concerns to the Ministry that if brand names are not to be used exports will be adversely impacted. as many importing countries may require a brand name for each product and Indian pharma companies have already established their presence in these overseas countries. The Indian Government was sympathetic with the point raised and agreed to consider the representation from Pharmexcil. Now, Pharmexcil is expecting a clarification from the DGCI /Ministry of Health and Family Welfare.”
“We have not conveyed any message to the pharma companies on the brand name issue till now. As mentioned, we have requested the Government to provide a clarification on the said directive,” Appaji added.