**Summary:**
This order, issued by the Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare on July 3, 2014, addresses clinical trials for medical devices. Following the recommendations of an Expert Committee chaired by Prof. Ranjit Roy Chaudhury, the Ministry has determined that the procedures for clinical trial approvals, investigator and site accreditation, ethics committee oversight, and other related conditions for medical devices will align with those established for new drugs and vaccines. This decision acknowledges the distinct nature of medical device clinical trials, particularly the absence of traditional phase-based trials focused on safety and tolerability. All concerned parties are directed to comply with this decision. The order was issued by Dr. G.N. Singh, Drugs Controller General of India, and distributed to IDMA, IPA, OPPI, ISCR, ACRO, NDAC, and MDAC members, with a copy to the USD of the Ministry of Health and Family Welfare. The file number for this order is 120114DC Pt.47.
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 Indian government ministry responsible for health policy.
New Delhi: City in India where FDA Bhawan is located.
Prof. Ranjit Roy Chaudhury: Chairman of the Expert Committee constituted by the Ministry of Health Family Welfare.
Expert Committee: Committee constituted by the Ministry of Health Family Welfare to formulate policy and guidelines for approval of new drugs, clinical trials, and banning of drugs.
Clinical Trial: A research study to evaluate the safety and effectiveness of a medical intervention (drug, device, etc.).
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
: Dated: 03.07.2014
ORDER
SUBJECT: Clinical Trial on Medical Device- 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.
Clinical Trial of Medical Device is different in nature as compared to that of Drugs
or Vaccine. In case of Medical Device, there is no concept of conducting Phase | Clinical
trial to assess safety, tolerability of the Medical Device. However, in pursuant to the
decision of the Ministry of Health and Family Welfare, it has been decided that the
procedures for the Clinical Trials approval, accreditations of Investigators, sites, Ethics
Committee and such other conditions would be similar to the Clinical Trials of New
Drugs/Vaccines
All concerned are hereby directed to comply with the above decision.
(Dr. G. N. Singh)
Drugs Controller Gepieral (India)
To:
1. IDMA/IPA/OPPI/ISCR/ACRO
2. NDAC / MDAC Members
CC to:
US(D), Ministry of Health and Family Welfare