India’s regulation of drugs and cosmetics is a parallel set up at the central and state level — we have the Central Drugs Standards Control Organisation (CDSCO) and State Drugs Control Departments (SDCDs). Such a dual system has its demerits. There is overlapping and there is no uniformity in interpretation and implementation of the Act. Ideally, there should be a single monitoring system.

The CDSCO acts as the Central Licensing Approving Authority for grant or renewal of licenses of blood banks, drug testing labs, vaccines, medical devices, sera, large volume parenterals and new drugs. The inspection is joint inspection. The report is given to the State Licensing Authority. It grants or renews the license. It is forwarded upwards to DCGI for ratification.

There is joint inspection for granting certificates to exporters. The testing samples drawn by central officers are sent to central testing labs and by the state officers to the state testing labs.

Capacity is assessed by joint inspection. CDSCO functions as a co-ordinating authority with states. Prior to granting of licenses in Form 28, 28 A. 28B, 28D or 28DA, there is joint inspection. In a proposed amendment to the Act, it is suggested that license in respect of 17 categories of drugs will be taken up by CDSCO. In respect of other categories of drugs, the powers vest with the state authorities.

There are two wings in the regulatory authorities — enforcement wing and laboratory wing. In enforcement wings, the functionaries are Drugs Controller General (India), Joint Drugs Controller (India), Deputy Drugs Controller (India), Assistant Drugs Controller (India) and Drug Inspector (India). In the lab wing, there is Principal Scientific Officer equivalent to Joint Drugs Controller, Chief Scientific Officer equivalent to Dy. Drugs Controller, Scientific Officer or Government Analyst equivalent to Assistant Drugs Controller and Junior Scientific Officers equivalent to Drug Inspector.

The organisation has five broad functions — enforcement and new drugs, import-export, pharmacovigilance and blood bank, lab and intelligence, HR and admn. medical services each headed by Joint Drugs Controllers. These report to DCGI who in turn reports to the Government. All of these are assisted by deputies and assistants at the middle level. At the bottom of the pyramid, we have drug inspectors and junior scientific officers.

Ideally, the central and state authorities should merge into one drug regulatory system. It will enable effective implementation of the Drugs and Cosmetics Act, 1940.