**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 provision of ancillary care to clinical trial subjects in India. File No. 120114DC Pt.47.
Following a report submitted by an Expert Committee chaired by Prof. Ranjit Roy Chaudhury regarding new drug approvals, clinical trials, and drug bans, the Ministry of Health & Family Welfare has mandated that sponsors, manufacturers, and clinical trial applicants provide ancillary care to clinical trial participants. This care should be provided within the same hospital/trial site and should address any brief illnesses experienced by subjects during the course of the trial.
The order is directed to IDMA, IPA, OPPI, IISCR, and CROs. Copies have also been sent to US D, Ministry of Health and Family Welfare. The issuing authority is Dr. G. N. Singh, Drugs Controller General of India.
Key Entities Referenced
Central Drugs Standard Control Organization: A regulatory body in India responsible for drug regulation.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare, India.
Ministry of Health Family Welfare: The government ministry responsible for health policy in India.
New Delhi: Capital of India, location of FDA Bhawan.
Prof. Ranjit Roy Chaudhury: Chairman of the Expert Committee constituted by the Ministry of Health and Family Welfare.
Expert Committee: Committee constituted by the Ministry of Health and Family Welfare to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization.
IDMA: Indian Drug Manufacturers' Association, an association of pharmaceutical manufacturers in 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
, Dated: 03.07.2014
ORDER
SUBJECT: Providing Ancillary care to the clinical trial subjects- 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 finalised by the Ministry of
Health & Family Welfare.
In pursuance to above, with regard to Providing Ancillary care to the clinical trial
subjects, it has been decided that there should be provision for providing ancillary care to
patients suffering from any other illness during the trial.
__ In view of above, all Sponsors / Manufactures/Clinical Trial Applicants are hereby
advised that such ancillary care should be provided to the clinical trial subject for brief
illness in the same hospital/trial site, wherever required.
(Dr. G. N. Singh)
Drugs Controller General (India)
To:
IDMA/IPA/ OPPI/1ISCR/ACRO
CC to: US (D), Ministry of Health and Family Welfare