With the formation of Central Drug Authority of India becoming a certainty soon, the drug control authorities in various states will have no role to play in regulating drug manufacturing activity and will be left with the job of only licensing and inspecting the chemist shops.

A clearer picture is now emerging on the role of the state drug departments under the CDA, even as the Parliamentary Standing Committee on Health & Family Welfare led by Amar Singh is in its last leg of study visits to different parts of the country. The Committee, which is examining the issues involved in creating the CDA, visited Mumbai on February 16 and 17.

According to informed sources, the proposed CDA will be entirely a new set up with autonomous powers. The CDA will have all the powers for issuing manufacturing licenses and licensing blood banks, while the existing state drug departments will be given the charge of overseeing sale and distribution of drugs.

For monitoring and inspecting the manufacturing, the CDA will appoint its own team of drug inspectors. There is a proposal to recruit 200 drug inspectors who will be posted in areas where there are concentration of drug manufacturing units. These drug inspectors will be posted directly under the CDA in Delhi, sources said.

Though the government had tabled Drugs & Cosmetics (Amendment) Bill, 2007 in Rajya Sabha on August 21 last year and was later referred to the Parliamentary Standing Committee to examine and put forth its suggestions, there was lack of clarity on several counts including the role of the state drug departments.

The confusion over the role of state drug departments was compounded by the Section 5 (d) and 5 (f) of the proposed Bill. Section 5 (d) says, "CDA shall recommend to the government measures to regulate manufacture for sale or for export or for distribution, or sale, stock or exhibition of drugs and cosmetics". Section 5 (f) says, "CDA may issue licenses under clause S/10, S/18 and S/33 EEC and collect fees". While S/10 is import, S/18 deals with manufacture and sale of allopathic drugs. S 33 EEC refers to ayurvedic drugs.