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NEW DELHI, Jan. 27

IN the first step towards strengthening the drug regulatory infrastructure, the Union Health Minister, Mr Shatrughan Sinha, has announced the setting up of a broad-based expert committee under the chairmanship of Dr Mashelkar to suggest concrete and time-bound measures for the purpose.

At a meeting with the pharmaceutical industry to discuss the issue of spurious drugs, Mr Sinha said that his Ministry was in the process of taking up a capacity building project to augment the drug testing facility in the country. This would facilitate the testing of about one lakh samples annually, against the present figure of about 38,000 samples. This could further reduce the time of testing to less than one month, he added.

Expressing his concern about spurious/counterfeit drugs in the market, the Minister said that the Health Ministry had taken a number of initiatives such as streamlining the licensing procedure for manufacture and sale of drugs, new import registration procedures for all drugs, revised benchmarks for Good Manufacturing Practices (GMP), computerisation and networking of all Central and State drug control offices and drug testing laboratories to ensure the quality of drugs and to harmonise regulatory requirements with the changing global practices. Outlining the legal requirements under the Drugs and Cosmetics Act 1940, he added that the responsibility to ensure the manufacture of quality drugs and to check movement of sub-standard drugs rests with the State governments.

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