The All India Drug Control Officers Confederation (AIDCOC), the national organisation representing drug control officers in the country, has objected the centre's move to enlarge the scope of Central Licensing & Approval Authority by taking over the state authority to issuing drug-manufacturing licenses.

The Centre's proposal, if implemented, will make the state drug control organisations only responsible for regulating sales and distribution of drugs and the CDSCO will be responsible for regulating the drug manufacturing activity. Currently state drug control organisations are regulating manufacturing, sales and distribution of drugs in their respective states.

AIDCOC reaction comes in the wake of a circular issued by the director in the Union ministry of Health & Family Welfare asking the State Governments on the scope of expanding this power of the CLAA. Mashelkar Committee had recommended the union government to take control of manufacturing licensing in a phased manner.

Addressing a letter to the director, Ministry of Health, AIDCOC secretary general, S W Deshpande, has pointed out that there are certain legal and logistical reasons that would make it impractical for the transfer of manufacturing licensing authority from the states to the centre.

The letter explains that, if the manufacturing activity is regulated by one agency and the sale and distribution by another agency, it could create logistic problems such as jurisdiction and co-ordination between the state and the central government. It may also affect speed and effectiveness of the investigation involving both traders and manufacturers, said the letter.

The letter argues about severe disparity in the number of drug inspectors and supervisory officers with CDSCO, which is far less compared to that of the state authorities or FDAs. For example, in Maharashtra 14 Assistant Commissioners and 25 drug inspectors are exclusively assigned the job of activities of the license of manufacturers. As against this, CDSCO (west zone) has only four drug inspectors and one deputy drug controller, adds the letter.

Above all, legally, the Drugs & Cosmetics Act has a specific provision that Section 18 of the Act, which is a prohibitory section, can come into operation only from such date as notified by the State Government. Therefore any immediate move to amend the Drugs and Cosmetics Act 1940 and Rules 1945 to take over the entire manufacturing licensing will create legal hurdles.

"Dr. Mashelkar committee had suggested the union government to take over the manufacturing licensing in a phased manner, and not in a hurry. Moreover, the committee's report clearly indicates that except for four states in the country, all other drug controllers have recorded their opposition to the concept of central licensing," stated Deshpande.