The Amar Singh panel's recommendation to strengthen the CDSCO and not to set up the much publicized Central Drug Authority at this stage is rather unexpected. The panel, at the same time, agrees with most provisions of the CDA Bill including a centralized licensing system with a network of zonal and sub zonal offices. The Bill is already placed in the Rajya Sabha on October 21. It seems that the main objection of the Amar Singh panel is against the naming of the Central body as CDA. The government has been ready with its plan to establish a centralized drug control machinery after considering the drawbacks of the current system of fragmented enforcement of drug rules by the state governments. Now, as the Amar Singh headed a parliamentary standing committee on health and family welfare, suggestions of the panel need to be incorporated into the Bill. That would mean the Drug Technical Advisory Boards for both allopathic and ASU drugs would continue to remain under the CDSCO. As per a cabinet note prepared last year, the CDA was to upgrade the national regulatory system for drugs and cosmetics to provide a technical vision and policy direction in respect of quality of drugs marketed in the country. It was proposed that the CDA will have ten main divisions to discharge functions under the Drugs & Cosmetics Act, 1940. The controversial move of centralization of issue of manufacturing licenses is going to be done in a phased manner. The grant of licences for sale of drugs, inspection of sale premises, monitoring the movement of spurious and sub standard drugs and investigations of such cases for taking action under the D&C Act would be looked after by the state licensing authorities. The states would also oversee operations of the state drug laboratories.

Formation of CDA was contemplated by the government considering the fast pace of growth of Indian pharmaceutical industry over the years. Need for centralizing the drug control administration was felt on account of the urgency in bringing some uniformity in enforcement of various new rules. Some of the key provisions of the D&C Act such as Schedule K, Schedule M, Schedule Y, etc. have been already amended and elaborated over the years considering the growth needs of this industry. Enforcement of all amended rules under the D&C Act is with the state health departments. But, the states have been usually lax in implementing these amended regulations and rules so far. This in effect has been making a mockery of the Act and rules in the pharmaceutical sector. Licensing of products has been one area where there is a lot of confusion prevailed in the country until last year. A new drug is approved for marketing by CDSCO but issuing licences for its manufacture is done by various state drug administrations. Although states and Union territories are having drug control departments, most of them do not have officials with sufficient competence to evaluate an application before a manufacturing licence is issued. Thus, even if one state drug licensing authority rejects an application for a product on technical grounds, the pharma companies used to get the approval from another state and market the product all over the country. The reason for uncontrolled growth of irrational and harmful combination products in the Indian market is this. A beginning has been made in this regard last year when for the first time the then DCGI ordered a ban on irrational combinations and directed state drug administrations not to issue licenses for any more drug combinations.