After a long gap of almost one and a half years, the Drug Controller General of India (DCGI) is convening the next Drugs Consultative Committee (DCC) meeting on October 28 which is expected to discuss several important issues pending for some time. Sources in the DCGI office said that a detailed 50-page agenda is being prepared by the DCGI office for discussion in the meeting.
Earlier, the DCGI had asked the state drug controllers to provide a list of issues that they wanted to raise in the meeting. Apart from the DCGI and other senior health ministry officials, all the state drug controllers are expected to attend the meeting.
DCC is a key regulatory body under the Union health ministry, constituted under the Drugs and Cosmetics Act, 1940 to provide advice regarding uniform implementation of the Drugs and Cosmetics Act and the Rules throughout the country. Major decisions are taken in the DCC meetings. Some of the major decisions took by the DCC meetings in the past included the crucial and controversial decision to weed out irrational FDC drugs from the market in June 2007 and the decision to phase out Artemisinin, the drug used as monotherapy to treat multi-drug resistant strains of falciparum malaria, from the Indian market in June last year.
Though the DCGI is yet to finalise the issues that will be discussed in the meeting, the meeting is likely to discuss important issues like regulation on medical devices, regulation on Clinical Research Organisations (CROs), the COPP issue and the lingering fixed dose combination (FDC) issue.
According to sources, the meeting will discuss the vexed FDC issue as there is lack of clarity on the issue, especially about the role the state drug controllers have to play. Though the Madras High Court had stayed the orders of the former DCGI Dr Ventakeshwarlu to withdraw irrational FDCs from the market, the state drug authorities are still in the dark on whether they have to follow the court order or the orders of the former DCGI. The issue will be raised in the proposed DCC meeting, sources said.