The Drug Controller General of India (DCGI) in a two day meeting that flagged off on February 4, met the members of the drug consultative committee (DCC) in Delhi, to discuss some of the important issues relating to effective implementation of the Drugs and Cosmetics (D&C) Act across the country. Important decision aimed at adopting better governance for ensuring availability of high quality medicines to the patients through better drug regulatory system will be taken during this meeting.
This meeting is perceived to be strategically important by the industry, as it is being organised following the issue of many important notifications by the CDSCO over the past months. The DCC members will be reviewing the implications of these recent notification in their respective states. It is also expected to help the DCGI to gauge on the stakeholders view and reaction on these issues through the SLA's.
Highly placed sources from the committee informed that one of the key points tabled for discussion during the meeting was on the issue of fixed dose combination (FDC) and ban of FDC's that did not have the permission of the DCGI. DCGI is said to have directed all the state drug licensing authorities (SLA's) to take strict action on this matter by mandating all the manufacturers to produce certificate proving safety and efficacy of the FDCs approved before October 1, 2012.
DCC members will also be discussing other important matters like detailed analysis over the status of grant of product license in the generic names only. Industry insiders maintain that there is still confusion and fear among them, due to lack of clarity on this matter. Incidentally, it is learnt that in spite of the DCGI notification notable number of SLA's are still granting product license in the brand name rather than generic name as required by the notification, citing lack of any directive from the respective state health ministry.
The meeting is also said to focus on othet important topics relating medical devices, use of generic drugs etc.