The Drugs Consultative Committee (DCC) of the central government will be taking a serious look at the key recommendations of the Mashelkar Committee on Drug Regulatory Reforms in its forthcoming meeting scheduled towards April end.

The focus of the discussions would be Mashelkar's proposals for more central monitoring and central interventions on the actions of state drug control agencies to bring about a uniform implementation of the Drugs & Cosmetics Act. The DCC being the only official body that has representation from all state drug regulatory agencies, any positive outcome of the meeting is to have far reaching implications.

The proposal for an independent auditing panel to assess the performance of drug regulatory departments and the delegation of sufficient powers to the central drugs standard control organization (CDSCO) to take suitable action against state drug authorities who are failing in their duties would be high on DCC agenda, it is learnt.

Amendment of Section 33 P of Drugs and Cosmetics Act to give powers to CDSCO to issue directives to state licensing authorities to review the orders passed by them and if necessary, to revoke the product licences granted by them would also be a topic for discussion in the meeting.

The Mashelkar committee had wanted DCC to deliberate on the issue of action to be taken on substandard drugs and review the existing guidelines. "The existing classification by DCC of defects found in substandard drugs into category A and category B and the action to be taken on each category of defects needs to be reviewed and updated," the committee had noted.

The committee had also called for a specific Medical Devices Division in reconstructed CDSCO (Central Drug Administration - CDA) for proper management of approval, certification and quality of medical devices. "An appropriate regulatory mechanism should be set up by CDA for certification, quality assurance and post-marketing surveillance of imported as well as locally made medical devices," the committee had noted.

The role of this apex committee is to advise the central government, the state governments and the Drugs Technical Advisory Board (DTAB) on any matter tending to secure uniformity throughout India in the administration of D&C Act.

The 35th DCC meeting is to examine these recommendations for forming appropriate guidelines or suggestions for follow up actions.