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2013 DIGILAW 8 (SC)

Swasthya Adhikar Manch, Indore v. Ministry of Health and Family Welfare

2013-01-03

ANIL R.DAVE, R.M.LODHA

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ORDER : In pursuance of our order dated October 8,2012, either the Secretary, Ministry of Health and Family Welfare, Government of India or Central Drugs Standard Control Organisation through Director General of Health Services, Government of India ought to have filed an affidavit on diverse aspects noted in that order. However, we find that an additional affidavit has been filed by Deputy Drugs Controller (India) in the Central Drugs Standard Control Organisation. This affidavit is hardly in compliance of the order dated October 8, 2012 and deserves to be ignored. We order accordingly. 2. We now direct that an affidavit in compliance of the order dated October 8, 2012 shall be filed within four weeks from today either by the Secretary, Ministry of Health and Family Welfare, Government of India or Central Drugs Standard Control Organisation through Director General of Health Services, Government of India. In the meanwhile, we direct the Chief Secretaries of the States other than States of Madhya Pradesh, Manipur, Union Territories of Dadar & Nagar Haveli and Daman & Diu to file their written responses on affidavit within four weeks from today. It will be the responsibility of Ms. Sushma Suri, advocate-on-record for the respondent No.1 - Union of India to inform the Chief Secretaries of the States/Union Territories of the above order without any delay. 3. In the meanwhile, we record and accept the statement of Mr. Siddharth Luthra, learned Additional Solicitor General that until further order by this Court, clinical trials of new chemical entity shall be conducted strictly in accord with the procedure prescribed in Schedule 'Y' of Drugs & Cosmetics Act, 1940 under the direct supervision of the Secretary, Ministry of Health & Family Welfare, Government of India. 4. List both the matters after four weeks. I.A. Nos. 6 & 7 of 2012: Issue notice on I.A. Nos. 6 & 7 of 2012 returnable along with the main matter.