The delegation of All India Drug Control Officer's Confederation (AIDCOC) in a representation urged the Central government, MPs and some political parties to review the proposal of setting up the central drug authority (CDA). It said that the central government should drop the proposal to take charge of issuing manufacturing licenses from state level authorities.

AIDCOC said, that centralising the licensing process and setting-up a central authority is inconsistent with the federal structure of the country. This would not result in efficient implementation of the Drugs and Cosmetics Act, 1940 as D&C Rules. Formation of such authority will affect the quality of monitoring exercise.

The representation clarified that formation of CDA could affect the states in terms of loss of revenue. This would create various issues and hurdles with respect to inspection of substandard and spurious drugs.

Though centralisation has been endorsed by Dr Mashelkar committee, it is doubtful that to what extend such process would bring in functional uniformity, the confederation says. It citied the example of other central government departments like Income Tax and Central Excise that are somewhat unable to achieve uniformity in tax collection or implementation.

AIDCOC is of the opinion that instead of centralising the manufacturing licensing, the government should consider strengthening of the existing system at central and district level. As declared in Pharmaceutical policy 2002, the Central Drug Standard Control Organisation (CDSCO) should be reinforced to effectively act as nodal agency.

Even if a central authority is formed it should be a substitute to the CDSCO rather than an additional arm to CDSCO. Simultaneously, independent drugs control organisations headed by the commissioner of drugs safety should be established at state level with necessary infrastructure, monetary allocation and human resource as recommended by Dr Mashelkar committee, the sources said.

The Central government should be either ideally monitor or should consider monitoring of implementation at state level. It should review the product approvals at state level, import and approval of new drugs as well as clinical trail approvals.

According to AIDCOC, the Central proposal is against the legislative scheme under the Drugs and Cosmetics Act and it mandates state to implement Acts and authorises Central government to consider policy and regulations. The subject is under concurrent list and the Central proposal is against the federal structure as well as division of power between central and state governments.

The delegation met the minister for external affairs Pranab Mukherji, minister for textile Shankar Singh Vaghela, and former minister for chemicals and fertilizers Suresh Prabhakar Prabhu. The group of MPs included Brinda Karat, Rupchand Murmu, Mohd. Saleem and Dr Sujan Charaborthy of CPI (M), and Devendra Prasad Yadav of RJD.