With the enforcement functions set to continue with the State licensing authorities even after the creation of the Central Drug Authority of India (CDAI) which seeks to bring in centralized manufacturing licences, the Ministries of Chemicals and Finance have suggested higher status to state drug controllers and strengthening of SLAs for effective enforcement services.
The Chemicals and Finance Ministries have made the observations in their comments on the formation of the CDAI. In its reply, the administrative ministry (health and family welfare) made it clear that the issue of the status of drug controllers in the States would be taken up separately and necessary steps would be initiated in this regard.
According to the draft cabinet note prepared on the formation of the CDAI, the proposed authority would upgrade national regulatory system for drugs and cosmetics and provide technical vision and policy direction in respect of quality of drugs marketed in the country. The authority would have ten main divisions to discharge functions as envisaged under the Drugs and Cosmetics Act, 1940. The centralization of issue of manufacturing licenses is proposed to be done in a phased manner.
However, the grant of licences for sale of drugs, inspection of sale premises and monitoring the movement of spurious and sub standard drugs and investigations of such cases for taking action under the Drugs and Cosmetics Act, 1940 would be looked after by the state licensing authorities. The states would also operate the State Drug laboratories, according to the health ministry.
In its comments on the CDAI, the Chemicals and Petrochemicals department has observed that in most states, the drug controllers were subordinate to Director, Health Services. The department said the stature of the hierarchy below the DCGI should also be raised when the status of DCGI was being raised to the level of additional secretary in the Centre.
The Finance Ministry also has made a similar comment, while sending its responses on the formation of the CDAI. ``while licensing of drug manufacturing units will be centralized, it may not be feasible to centralize the enforcement function. Since weak enforcement is one of the crucial problems in the drug regulatory system, the strategy for improving the enforcement may be elaborated. Merely establishing CDAI is not likely to result in better enforcement,'' the Department of Expenditure under the finance ministry has written to the Health Ministry.
The health ministry, in its reply, said it would continue with the present enforcement through the States. But the centre would take steps to strengthen the state enforcement machinery. A capacity building project for food and drugs was already under implementation, it said.
``The CDA through its network of zonal and subzonal offices would have a presence in most of the states where there is a significant drugs manufacturing activity. This would facilitate central licensing and GMP certification. It is proposed to adopt a gradual switchover to central licensing over a five-year period. It is proposed that the CLAA system be modified to become a direct central licensing system and the list of products to be covered expanded gradually over a five year period until all drugs formulations are covered under the central licensing,'' the cabinet note said.