The Health Ministry is to give three months time to Mashelkar Committee for Review of Drugs Regulatory System in India and to submit its final report. This is after the committee made a formal request seeking more time to complete its assignment. The committee, formed in January 2003, was expected to submit the report within six months.
The agenda before the committee includes the strengthening of the laws to check the spurious drug problem which is reportedly on the rise. It is also to comment on the possibilities of introducing a centralized drug licensing system. The committee had been giving a patient hearing to the problems being faced by all sections of the industry. All practical suggestions from individual stake holders would be accommodated with an aim to improve the efficiency of the drug regulatory system, it is learnt.
The committee had appointed two sub-groups to have a more focused approach on various issues involved. The final reports of these sub-groups are to be taken up for discussion soon.
Constitution of special courts to try spurious drug cases and establishment of a network of informers are also actively considered by the committee. The sub-group members had expressed displeasure over the ineffectiveness of the existing judicial system in curbing the manufacture and distribution of spurious drugs.
Indian Drugs Manufacturers Association (IDMA), Indian Pharmaceutical Alliance (IPA), Indian Pharmaceutical Association, Organisation of Pharma Producers of India (OPPI), All India Organisation of Chemists and Druggists (AIOCD), VOICE (a consumer organization which conducted a study on drugs), commissioner FDA of Maharashtra, drug controllers of Bihar, Haryana and Delhi, officials from various ministries, are all members of the committee.
Mashelkar Committee has representatives from various ministries including Law Ministry, Home Ministry, Chemicals and Fertilizers Ministry and Health and Family Welfare Ministry.