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AIDCOC expresses concern over CDSCO's move to centralise drug licencing

Suja Nair Shirodkar, Mumbai
Thursday, June 19, 2014, 08:00 Hrs  [IST]

To enhance drug regulatory and monitoring mechanism in the country, the All India Drugs Control Officers’ Confederation (AIDCOC) recently sent a representation to union health ministry expressing concern over centralisation of the power at the Centre and urged the government to continue following federal structure and legislative scheme under the Drugs and Cosmetics Act, 1940.

The confederation strongly feels that since India is a federal country with clear division of responsibility between the Central government and State government, with defined division of responsibilities, it should not be changed or tinkered with. AIDCOC stressed that bringing any changes to the present structure will create chaos and confusion in the industry, that will further complicate effective and smooth implementation of the Act.

Similarly, they stressed that rather than bringing in changes in the structural functions, steps should be taken to analyse the weakness in the present structure, so as to strengthen it by taking decisive action. The AIDCOC in the past has also raised this issue in the parliamentary standing committee severely criticising the Central Drugs Standard Control Organisation (CDSCO)'s proposal to centralise the entire drug licencing system by curtailing the powers of the state DCAs.

According to Ravi Uday Bhaskar, secretary general, AIDCOC “We strongly feel that the CDSCO's proposal to centralise the authority is unwarranted especially since drug licencing is not an issue with the consumers.  It is the responsibility of the drug regulators to ensure drug licencing as per the provisions and since the state regulators have better understanding of their area they should be given the right to issue licence and not the Centre. Rather than indulging in creating further complication, the CDSCO should focus on constructive development, as such move will only lead to delay the licencing system in the country.”

For some time now, the CDSCO has been trying to centralise the entire drug licencing system. Interestingly, health being on the concurrent list can be legislated by either by the Centre or the State government based on subject matter.  Bhaskar informs that subjects such as legislation, policy making, import, clinical trials and new drug approvals are with central government, while licencing including implementation is with the state governments.

In the representation that was recently made to the government, the Confederation stressed that import, manufacture, sale and distribution is regulated under Central Act namely Drugs and Cosmetics Act, 1940.  The federal scheme is reflected in it with well defined division of responsibilities of powers of Central government and State government. Confederation stressed that since manufacture, sale and distribution of drugs and cosmetics is a composite activity, licencing for all activities should remain with one agency i.e. with state government as per existing practice for effective implementation.


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