(a) whether the Government have any proposal about the new provision in the drugs and cosmetic rules for the registration of the manufacturing premises of foreign drug manufacturers; and
(b) if so, the details thereof?
(a) whether the Government have any proposal about the new provision in the drugs and cosmetic rules for the registration of the manufacturing premises of foreign drug manufacturers; and
(b) if so, the details thereof?
THE MINISTER OF HEALTH AND FAMILY WELFARE (DR. C.P. THAKUR)
(a) & (b): Ministry of Health and Family Welfare vide Gazette of India Notification No. GSR604(E) dated 24.08.2001 have made a new provision in the Drugs and Cosmetics Rules for the registration of manufacturing premises of foreign drug manufacturers. This will come into effect from 01.01.2003.
The application for issue of a Registration Certificate for a manufacturing premise and each manufactured drug by a foreign drug manufacturer for import in India is to be made as per Rule 24-A alongwith the fee of US $1500 and US$1000 respectively.
Details are available in GSR No.604(E) dated 24.08.2001 which is a published document.