The Drug Controller General of India (DCGI) Dr Surinder Singh has called an emergency Drugs Consultative Committee (DCC) meeting on February 15 to discuss several burning issues including banning of several controversial drugs like nimesulide suspension, gastroprokinetic agent cisapride, decongestant drug Phenylpropanolamine (PPA) and human placenta extracts which has been hanging on fire for some time.
According to sources, the urgent DCC meeting has been called by the DCGI as he has to present details on several issues to the department related parliamentary standing committee on health and family welfare which is meeting on February 18. The parliamentary committee has shot off several questions to the union health ministry regarding several issues and the ministry has asked the DCGI to present complete details on these issues before the committee in its meeting on February 18.
Agenda of the special DCC meeting include the issues arising out of the stalemate on banning controversial drugs like nimesulide suspension, cisapride, Phenylpropanolamine (PPA) and human placenta extracts, which are still available in the Indian market while they have been banned in most of the countries in the world.
Another point for discussion in the meeting is the issue of drug licenses being issued by the state drug controllers for new drugs which is not permitted as per Drugs and Cosmetics Act. As per rules, only the DCGI is authorised to approve permission for new drugs to the pharma companies. The meeting will also discuss the issue of approval of different drugs with same brand name by the state drug authorities.
Other issues on the agenda include the promotion of generic drugs, audit of state drug testing laboratories and the uniform implementation of Drugs and Cosmetics Act.
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 taken 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 2009.
Holding after a long gap of almost one and a half years, the last DCC meeting, held on October 28, 2010, took several important decisions including the decision to introduce new rules to regulate the sale of antibiotics in the country.