The Union Health Ministry's high level committee, constituted for examining and recommending amendments in the Drugs and Cosmetics Rules, 1945, has set up seven sub-groups for different segments like drugs, medical devices, clinical trials, biologicals, blood banks and cosmetics with a nodal person from the industry and a resource person from the CDSCO.
Vikas Kumar of ISCR will be the nodal coordinator for the sub-group on Clinical Trials (Drugs), while Dr. A.K Pradhan, DDC(I), will be the CDSCO resource person of this sub-group. Sumati Randeo of CII will be the nodal coordinator for the sub-group on Clinical Trials (Medical Devices & IVD), while Dr. Eswara Reddy, JDC(I), will be the CDSCO resource person of this sub-group.
The sub-group on Pharmaceuticals has three nodal coordinators from the industry--Arun Mishra (CII), Ashok Madan (IDMA) and
Meenu Batolar (OPPI). Dr. V.G. Somani, JDC(I), has been made the resource person of this sub-group from the CDSCO.
Rakesh Sharma of FICCI will be the nodal coordinator for the sub-group on Medical Devices & IVD, while Dr. Eswara Reddy, JDC(I), will be the CDSCO resource person of this sub-group. Shobha Mishra Ghosh of FICCI will be the nodal coordinator for the sub-group on Biological & OTC, while Dr. V.G. Somani, JDC(I), will be the CDSCO resource person of this sub-group.
Likewise, Elzabath Jose of CII will be the nodal coordinator for the sub-group on Blood Bank, while Dr. V.G. Somani, JDC(I), will be the CDSCO resource person of this sub-group. Sumeet Jaiswal of IBHA will be the nodal coordinator for the sub-group on Cosmetics, while Dr. Sudipta, DDC (I), will be the CDSCO resource person of this sub-group.
Dr. B. R. Jagashetty, National Advisor (Drugs) will be the overall coordinator for all sub-groups.
The first meeting of this high powered committee, under the chairmanship of Joint Secretary (Regulation), Department of Health and Family Welfare, was held on January 21, 2015. Besides the committee members, the meeting was attended by representatives of industry associations. It was agreed in the meeting that 31st January, 2015 would be the last date for sending comments on the proposed amendments in the said Rules.
Earlier in December 2014, the union health ministry decided to constitute this high level committee to expeditiously revisit the Drugs and Cosmetics Rules, 1945 and make recommendations for amending the same in order to make these rules contemporary while keeping in view the requirements of quality, safety and efficacy of medical products and also the efficiency of regulatory structures and the industry and to keep pace with changing scenario of drugs, medical devices and cosmetics industry.
The other members of the committee are Dr B R Jagashetty, National Advisor (Drugs Control) and Project In-charge; S R Dhaleta, Retired Joint Secretary & Legislative Counsel, Legislative Department, Ministry of Law & Justice; a representative of the Department of Legal Affairs, Ministry of Law & Justice;a representative of Department of Pharmaceuticals; Dr V G Somani, Joint Drugs Controller (ad-hoc), Central Drugs Standard Control Organization; D K Shringi, Retired Drug Controller, Rajasthan; G L Singhal, Retired Drug Controller, Haryana; Dr G Selvaraj, Retired Deputy Drug Controller, Tamil Nadu; and representatives of all Industry Associations.