**Summary:**
This order, issued by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare on July 3, 2014, addresses the number of Indian subjects required in Phase III Global Clinical Trials for drug approval in India. The order stems from recommendations made by an Expert Committee, chaired by Prof. Ranjit Roy Chaudhury, which was tasked with formulating policies and guidelines for new drug approvals, clinical trials, and drug banning. The Ministry of Health & Family Welfare finalized actions based on the Expert Committee's report, deciding that adequate Indian participation in Phase III Global Clinical Trials is necessary for considering a drug's approval in India. The order directs all New Drug Advisory Committee (NDAC) experts to evaluate new drug applications, ensuring adherence to this requirement. The Drugs Controller General of India, Dr. G.N. Singh, issued the order. Copies were distributed to NDAC Members, IDMA, IPA, OPPI, ISCR, ACRO, and CC, as well as the US (D), Ministry of Health and Family Welfare. The file number for this order is 120114DC Pt.47. The location of the issuing office is FDA Bhawan, Kotla Road, New Delhi-110002.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare, providing technical expertise in public health.
Ministry of Health and Family Welfare: A government ministry responsible for health policy in India.
New Delhi: The capital city of India and the location of the FDA Bhawan.
Phase III Global Clinical Trials: Late-stage clinical trials conducted internationally to assess the efficacy and safety of new drugs.
Prof. Ranjit Roy Chaudhury: The Chairman of the Expert Committee constituted by the Ministry of Health Family Welfare.
NDAC: An abbreviation that refers to a committee of experts requested to evaluate applications of new drugs.
Dr. G. N. Singh: Drugs Controller General of India
File No. 12-01/14-DC Pt.47
Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health & Family Welfare
FDA Bhawan, Kotla Road, New Delhi-110002
Date:03.07.2014
ORDER
SUBJECT: Number of subjects in Phase Ill Global Clinical Trials - regarding
The Ministry of Health & Family Welfare had constituted an Expert Committee
under the Chairmanship of Prof. Ranjit Roy Chaudhury to formulate policy and guidelines
for approval of new drugs, clinical trials and banning of drugs. The Expert Committee
submitted its report to the Ministry of Health & Family Welfare. The actions proposed to be
taken on the recommendations of the Expert Committee were finalized by the Ministry of
~ Health & Family Welfare. :
Pursuant to above, it has been decided that if Indians have participated in Phase
III Global Clinical Trials, the number of participants would have be adequate for considering
approval of the drug in India.
In view of above, all the NDAC experts are requested to evaluate applications of
such new drugs NDAC adhering to the above said requirement.
(Dr. G. JN. Singh)
Drugs Controller Gengral (India)
To
1. NDAC Members
2. IDMA /IPA/ OPPI/ISCR / ACRO
CC to:
US (D), Ministry of Health and Family Welfare