Health Ministry decided that academic clinical research may be approved by the Institutional Ethics Committee, however, in the case of new drug is being evaluated or a new use of an existing drug is being evaluated, then approval of DCG(I) is required at 70th meet of DTAB.
Clinical trials on new drugs are regulated under the provisions of the Drugs and Cosmetics Rules, 1945. Rule 122DA provides that ‘No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any institution, shall be conducted except under, and in accordance with, the permission, in writing, of the Licensing Authority’. Further, Rule 122E includes not only the new molecules but also the new claims namely new indication, route of administration, dosage, etc. of already a pproved drugs.
Under these provisions conduct of clinical trial of already approved drugs for new claim by any Institution / Medical Researcher for academic purposes require prior permission of DCG(I).
Concerns were raised regarding difficulties in submission of application to DCG(I) for such clinical trials by the Investigators/medical students from different parts of the country and subsequently making presentation before the SECs for their approval. It was felt that the cumbersome procedures for obtaining permissions in each and every case of academic research is not permitting free growth of academic clinical research in the medical institutions.
The members were briefed that the Prof. Ranjit Roy Choudhury Committee had recommended that academic research may be approved by the Institutional Ethics Committees (IEC). The approval of DCG(I) should only be required if a new drug is being evaluated or a new use for an existing drug is being tried out. It was therefore decided by the Ministry of Health and Family Welfare that academic clinical research may be approved by the Institutional Ethics Committee, however, in the case of new drug is being evaluated or a new use of an existing drug is being evaluated, then approval of DCG (I) is required as per rules.
In the countries like USA which has well regulated clinical research provide exemptions for submission of IND application to USFDA under certain conditions depending on the intent of trial and the risk involved.
In view of the above it was proposed that a provision may be provided under the Drugs and Cosmetics Rules, 1945 that permission for clinical trial purely for academic research may be approved by the Institutional Ethics Committees. The approval of DCG(I) should be mandatory only when the new drug is being evaluated or a new use for an existing drug is being tried out under certain conditions.
A proviso to the rule 122 DA relating to application for permission to conduct clinical trial for new drug / investigational new drugs was proposed to be introduced as under to provide specific exemptions in the case of clinical trials for academic research as under:
Provided that permission for conduct of clinical trial is not required from the licensing authority if the study is related to already licenced or approved drug and drug formulations permitted to be marketed, for new indication, new route of administration, new dose, etc. for academic research purposes and complies with the following conditions.
i. The trial has been duly approved by the Ethics Committee.
ii. The data generated is not intended for submission to any regulatory authority.
The DTAB after deliberations agreed to the proposed amendment.
