The two sub-groups set up by the high-power Mashelkar Committee to look into various drug regulatory issues in the country and suggest measures for effective implementation of the laws, will have its initial meetings on April 29 and 30 in Delhi.
The high-power committee headed by Dr R A Mashelkar, Director General, Council for Industrial and Scientific Research (CSIR) had these committees to meet once in a month and discuss specific issues pertaining to drug regulations.
While spurious drug issue would dominate the discussions in the first meeting of a sub group, the second sub group would be concentrating on suggesting measures intended to strengthen the regulatory infrastructure in the country to make it a truly world class set up, it is learnt.
Indian Drugs Manufacturers Association (IDMA), Indian Pharmaceutical Alliance (IPA), Indian Pharmaceutical Association, Organisation of Pharmaceutical 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 etc are members of the first committee. The second one will have all Industry associations barring OPPI, Drug Controllers from Karnataka, West Bengal and Delhi, and other officials from the ministries.
The sub-committees are to give their suggestions to enable the Mashelkar committee to come out with a roadmap for the effective implementation of the Drug regulatory laws and also recommend significant changes in the Drugs and Cosmetics Act, intended to make it more stringent and powerful. Mashelkar Committee has representatives from various ministries including Law Ministry, Home Ministry, Chemicals and Fertilizers Ministry and Health and Family Welfare Ministry. The committee is to submit its report within six months from now.
The sub-group has been asked to evaluate the extent of the problem of spurious medicines in the country at the first meeting on April 29. The problem of manufacture and sale of medicines without licenses, without invoices and by people who are not qualified to do so would be evaluated by the sub-committee. It is to study the commercial, handling, storage, transportation practices and methodologies adopted by the commerce in distribution (including transit and transit shortage) of medicines, besides business modalities adopted at major transit points. Recommendation of measures and practices to be followed to ensure better distribution of medicines, recommend training context and outlines for regulatory officials, recommend changes required in existing legal provisions, measures for speedy trials in courts, review the role played by the industry and professional and trade associations in the gamut of drug manufacture and distribution, export related issues in the context of substandard and counterfeit drugs, and recommendation for a surveillance system to control and check the menace of substandard and spurious medicines in the country are the other items in the agenda of the first meeting.
The second sub-committee has been asked to study the contemporary regulatory setups in countries like China, Malaysia, Thailand, Indonesia, South Korea, Australia, UK, USA, Brazil, Mexico and South Africa and suggest measures to strengthen the regulatory infrastructure in the country. The sub-committee would define the scope, role and responsibilities of the proposed National Drug Authority. Analysis of the functioning of select state drug control authorities and identifying the problems faced by them in implementing the drug regulations is another exercise to be taken up by the sub-committee. There will also be discussions on extending the regulatory arm towards other functional areas other than medicines (medical devices, diagnostics, promotional literatures, clinical research, pharmacovigilance, newer therapeutics, neutraceuticals etc).