**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 conduct of placebo-controlled clinical trials in India. It references the report submitted by an Expert Committee chaired by Prof. Ranjit Roy Chaudhury, which was constituted to formulate policy and guidelines for new drug approvals, clinical trials, and drug banning.
The order emphasizes that while placebo-controlled trials are becoming less common due to the availability of existing therapies for comparison, they may still be appropriate in specific circumstances. It stipulates that pharmaceutical companies, investigators, drug regulators, and Ethics Committees (ECs) must ensure that the design of any placebo-controlled clinical trial is appropriate, efficient, and ethical.
Specifically, sponsors, Contract Research Organizations (CROs), clinical trial applicants, and ECs are directed to adhere to these principles. The order also requests that the New Drug Approval Committee (NDAC) members only consider placebo-controlled trials for approval if their designs meet these criteria.
The order was issued by Dr. G.N. Singh, Drugs Controller General of India. Copies were distributed to NDAC Members, IDMA, IPA, OPPI, ISCR, ACRO, CC, and the US D, Ministry of Health and Family Welfare. The file number for reference is 120114DC Pt.47.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Ministry of Health Family Welfare: The government ministry responsible for health policy in India.
Expert Committee under the Chairmanship of Prof. Ranjit Roy Chaudhury: A committee constituted by the Ministry of Health and Family Welfare to formulate policy and guidelines for drug approval, clinical trials, and drug banning.
Placebo controlled trials: Clinical trials where a control group receives a placebo instead of the drug being tested.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization, responsible for drug regulation in India.
NDAC: An unspecified committee or group, likely related to drug approval within the Central Drugs Standard Control Organization.
IDMA: Indian Drug Manufacturers' Association.
New Delhi, Delhi: The location of FDA Bhawan, Kotla Road, where the order was issued.
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: Placebo controlled 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. :
As mentioned in the report, Placebo-controlled trials are fairly uncommon these
days, although there will always be a case for such trials in special circumstances. Since
other remedies are usually available, the drug to be tested is compared to the existing
therapy. There is thus no reason to deprive a patient of a drug in such placebo controlled
trial. The pharmaceutical companies, the Investigators, the drugs regulator and the ECs all
would have to ensure that the design used in a placebo controlled clinical trial is
appropriate, efficient and ethical.
In view of the above, all the sponsors/CROs/Clinical trial applicants/Ethics
Committees are required to ensure that the design used in a placebo controlled clinical trial
is appropriate, efficient and ethical. The NDAC members are also requested to ensure that
only those placebo control trials, design of which are appropriate, efficient and ethical
considered for approval.
. (Dr. G} N. Singh)
Drugs Controller Gengéral (India)
1. NDAC Members
2. IDMA/IPA/ OPPI/ISCR /ACRO
CC to:
US (D), Ministry of Health and Family Welfare