The Drug Controller General of India (DCGI) will convene the next Drugs Consultative Committee (DCC) meeting on June 29 which is expected to discuss several important issues which have been pending for some time. The last DCC meeting was convened on December 10 last year in which several crucial decisions were taken including the decision to phase out Artemisinin, the drug used as monotherapy to treat multi-drug resistant strains of falciparum malaria, from the Indian market.
The meeting, which will be the 40th DCC meeting, is likely to discuss important issues like regulation on medical devices, regulation on Clinical Research Organisations (CROs) and the progress in resolving the FDC issue. However, the DCGI is yet to issue any instructions on the agenda which will be discussed 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. It was in the DCC meeting held on June 4, 2007 which took the crucial and controversial decision to weed out irrational FDC drugs from the market.
According to sources, the meeting may discuss the WHO-GMP issue and also the COPP issue.
Another major issue what will be raised in the meeting is the regulation on CROs. At present, the state drug authorities give licences to the CROs under Form 29. They have no powers to oversee the functioning of the CROs. The state authorities will seek clarity about their role in regulating the CROs in their respective states.
The meeting will also discuss the issue of medication devices regulation. At present, the government is preparing a detailed regulation on the medical devices industry which is by and large an unregulated segment in the country.