The 39th Drugs Consultative Committee (DCC) meeting, to be held on December 10 in New Delhi, is likely to discuss the issue of how to phase out the Oral Single Drug Formulations (OSDF) of Artemisinin and its derivatives from the market on the recommendations of World Health Organisation, it is learnt.
Artemisinin is a drug used to treat multi-drug resistant strains of falciparum malaria. It was part of the new class of anti-malarial drugs known as Artemisinin-based Combination Therapies (ACTs). ACTs were significant because they had been approved by various international health organizations such as the WHO and the United Nations Children's Fund (UNICEF) as the first-line treatment for malaria in Africa.
The DCC meeting, which is convened by the Drugs Controller General of India, is characterized as 'WHO Workshop on Dissemination of Information on Regulatory Affairs' as it is funded by the world health organization. Though the DCGI has sent directives to this effect to all the state drug controllers, only the drug administrations of Maharashtra, Goa, Karnataka, Gujarat, Tamil Nadu and Delhi have offered subjects of issues for discussion to include in the agenda of the DCC.
According to sources, among other things, the meeting will deliberate on a proposal to amend the Drugs and Cosmetics Rules to regulate import, manufacture and sale of medical devices in the country. Besides, uniform implementation of this D&C Act will also be discussed at the meeting.
The meeting will also examine the action taken report on the matters arising out of the 38th meeting of the DCC held on 4th June last year in New Delhi.
Testing of statutory drugs samples drawn by state drug inspectors by the state drug testing laboratories instead of central drug testing laboratories is another subject the drug controllers of India is going to ponder over in the meeting with the DCGI.
Another crucial issue that is going to arise in the DCC for discussion is about grant of WHO GMP certificates by the state licensing authorities.
DCC is an advisory 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.