|
Issue of Drug Licenses without Brand Names – Present Status
|
To
All the Members of Council,
Dear Member,
Subject: Directive of Central Government to State Drugs Controllers to issue Drug Manufacturing license for formulations under Proper/Generic name only – action taken by Pharmexcil
As our members are aware, subsequent to the issue of Direction by Ministry of Health & Family Welfare to State Governments on the above subject (copy enclosed), Pharmexcil has brought it to the notice of our members and invited their comments/inputs through our circular dt. 17.10.2012 (copy enclosed). Some members have submitted their comments on this issue.
As the subject directive from the Government of India is applicable to exported products also, based on inputs received from members, our Council has submitted a representation to the Government (copy enclosed) and followed up with the Govt. Pharmexcil has participated in a meeting where senior officers of the Ministry of Health and Department of Commerce discussed this issue. It was explained to the officers that several State Drug Control Organizations have started implementing the directive of the Ministry of Health and consequently several exporters are facing severe problems in obtaining manufacturing licenses with brand names and export of shipments as per export orders.
After sympathetically noting the genuine problems of exporters and the requirements of several countries for import of medicines with brand names, it is indicated that appropriate action would be taken by issuing necessary clarifications to the State Governments for ensuring smooth and hassle-free exports. Keeping in view the increasing problems being faced by our members, Pharmexcil is further following up the matter with the authorities. It is expected that Goverment would issue appropriate clarifications to the State Authorities very soon.
Members may kindly note the above position.
Yours faithfully,
Dr. P. V. Appaji,
Director General
Latest Circulars
|
