After one and a half years since the last meeting, the next Drugs Consultative Committee (DCC) meeting will be convened on December 10. The Drug Controller General of India (DCGI) has sent directives to this effect to all the state drug controllers.
However, the DCGI is yet to finalise the issues that will be discussed in the meeting as the directive did not mention about the issues that will be discussed in the meeting. "The agenda of the meeting will be informed later", the DCGI directive said.
The DCC meeting is being convened after one and a half years of the last meeting which took the crucial and controversial decision to weed out irrational fixed dose combination (FDC) drugs from the market.
According to sources, the meeting will discuss several crucial issues which have been pending for some time. It is likely to discuss important issues like regulation on medical devices, regulation on Clinical Research Organisations (CROs) and the lingering FDC issue. On the DCGI directive, the state drug controllers have sent their 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. The last DCC meeting was 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 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.
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 medical devices regulation. At present, the government is preparing a detailed regulation for the medical devices industry which is by and large an unregulated segment in the country.