The Union health ministry will soon amend the Drugs and Cosmetics Rules, 1945 for providing exemption in the case of clinical trials undertaken in the medical institutions or hospitals for academic research. Once the amendment is done, these institutions and hospitals do not have to take the now mandatory prior permission from the Drugs Controller General of India (DCGI).

According to sources, the Drugs Technical Advisory Board (DTAB), the highest authority under the Union health ministry on technical matters, in its 70th meeting held on August 18, 2015, has given its approval for a proposal by the ministry in this regard.

There were concerns regarding difficulties in submission of application to DCGI for such clinical trials by the investigators and medical students from different parts of the country and subsequently making presentation before the subject expert committees (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 Prof. Ranjit Roy Choudhury Committee had also recommended in its recent report that academic research should be approved by the Institutional Ethics Committees. The approval of DCGI 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 DTAB meeting, 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 DCGI 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 conditions that the trial has been duly approved by the Ethics Committee and the data generated is not intended for submission to any regulatory authority.

After deliberations, the DTAB agreed to the proposed amendment.

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 approved 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 DCGI.