With the Cabinet stamping its approval on the much-awaited proposal for a Central Drugs Authority of India, on the lines of the US FDA, the present system of grant of manufacturing licences by the States would be replaced by a complete central licensing system under the Union Government.
The Drugs and Cosmetics Amendment Bill, 2006 would be introduced in the Winter Session of the Parliament with changes to amend the Drugs and Cosmetics Act, 1940.
The autonomous apex body on drugs will however be set up under the Ministry of Health and Family Welfare, at the Food and Drug Bhavan. A phased five year transition will be in place from the present system of grant of manufacturing licences to a complete central licensing of drug manufacturing units from State to Union Government.
The moves, coming after a long wait, are expected to facilitate upgradation of national drugs regulator, uniformity of licensing and enforcement and improvement in quality and safety of drugs.
The Cabinet met last night, also decided to upgrade the post of Drug Controller (India) from the present level of the grade of Joint Secretary to the Additional Secretary to the Government of India. One post of Additional Drugs Controller (India) (AYUSH) in the grade of Joint Secretary will be revived.
The Government also decided to create a post of Additional Drugs Controller (India) in the grade of joint secretary.