Government of India Ministry of Health and Family Welfare Department of Health and Family Welfare Lok Sabha Unstarred Question No

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GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE LOK SABHA UNSTARRED QUESTION NO. 1899 TO BE ANSWERED ON 29TH DECEMBER, 2017 STUDIES ON CLINICAL TRIALS 1899. SHRI BHARATHI MOHAN R.K.: Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state: (a) whether the Government has conducted any study to find out the impact of clinical trials and introduction of new drugs for treatment of various diseases in the country; (b) if so, the details thereof; (c) the detailed list of clinical trials conducted during the last five years by various pharmaceutical companies in both Government and Private Sector; (d) whether the Government has given any approval for any such clinical trials in Tamil Nadu in the last three years; and (e) if so, the details thereof and the list of drugs/medicines given approval for the clinical trials during the last three years? ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY) (a): No. (b): Does not arise. (c): The detailed list of clinical trials conducted during the last five years by various pharmaceuticals companies is annexed. (d) & (e): Clinical trials of new drugs are regulated under Rules 122DA, 122DAB, 122DAC, 122DD and Schedule-Y of the Drugs and Cosmetics Rules, 1945. Most of the clinical trials are multicentric studies conducted in multiple sites across the country. Central Drugs Standard Control Organisation (CDSCO) grants permission to conduct clinical trial in the country without any State specific permission. ...................... ANNEXURE S.

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