DCGI to constitute expert committee for regulation of new drugs, INDs

In case of proposals of anti TB, anti HIV drugs and anti-malarial drugs, the expert from respective program divisions will also be included in the SEC

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Meeting Committee FDA
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CDSCO

The Drugs Controller General of India (DCGI) is planning to constitute one or more expert committee or groups of expert with specialization in relevant fields for regulation of New Drugs, Investigational New Drugs (INDs) for human use, clinical trials, bioequivalence study, bioavailability study and ethics committee as per the New Drugs & Clinical Trials (NDCT) Rules, 2019 which have been notified with effect from March 19, 2019.

Accordingly, under Rule 100 of the New Drugs & Clinical Trials Rules, 2019, with approval of Union health ministry, groups/panels of about 550 medical experts with specialization in relevant fields including existing members of the SECs from various Government medical colleges/institutions are constituted with following Terms of References (ToRs) which implies that from the given panel of experts, subject expert committee (SECs) in various therapeutic areas will be constituted comprising 8 medical experts (1 Pharmacologist and 7 medical specialists) drawing the names of the experts from the respective panels.

As per the rule 100 of the NDCT Rules, 2019, Central Licensing Authority i.e., DCG(I) may, when so required, constitute one or more expert committee or groups of expert with specialization in relevant fields, with the approval of Central Government, to evaluate scientific and technical matters relating to drugs, and may give its recommendations to that authority on matters referred to it as prescribed in the rule, as per a DCGI notice.

In case, any expert fails to attend the SEC meeting, the next experts of the same panel will be invited to attend the meeting for evaluation of clinical trials and new drug applications. These Committees will evaluate and advise DCG(I) on following proposals of various categories of applications for approval of new drugs, clinical trials and new medical devices.

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New drug substance of chemical and biological origin and new medical device to be introduced for the first time in the country including vaccines and r-DNA derived products/subsequent approval of New Drugs, Biologicals products including vaccines and r-DNA derived product already approved in the country/global clinical trials/fixed dose combinations of two or more drugs to be introduced for the first time in the country/causality analysis , safety of drugs or any other technical matter which require expert advice in the opinion of Union health ministry or DCGI.

SECs in various therapeutic areas will be constituted by CDSCO from time to time on a need basis drawing the experts from the above panels for evaluation of new drugs, investigational new drugs including cellular biology based drug products/stem cell derived products, new medical devices etc.

In case of proposals of anti TB, anti HIV drugs and anti-malarial drugs, the expert from respective program divisions will also be included in the SEC. Further, in case of Investigational New Drug (11\10) representative from Indian Council of Medical Research (ICMR) and for Biotechnology (r-DNA) based products, representatives from Department of Biotechnology (DBT) respectively would be invited.

Applications for new drugs and medical devices, clinical trials will be evaluated by experts through meetings in person or through video conferences. TA/DA for attending the meetings as well as fees will be paid from the budget of Indian Pharmacopoeia Commission, Ghaziabad. The expert nominated as a member for the SEC should not have any conflict of interest as per the declaration. The members of the committee shall hold office for a period of three year but shall be eligible for re-nominating provided that the persons nominated continue to hold their offices in their respective organization by virtue of which they are nominated. However, pending approval of such extension, the members will continue to work as experts and no decision arrived at by such a group of experts will be treated as null or void solely on the ground that no extension was granted to them.

The members of these committees shall give their expert comments in writing after evaluating the proposal within a period of 6 weeks from the receipt of such proposal even if they fail to attend the meeting. The committee shall evaluate the proposals of new drugs and clinical trials and new medical devices keeping in view the requirements as prescribed in the regulatory framework. The expert committees will review the proposal and give their recommendations in a composite manner as far as practical. In case of query/suggestions for modification/revision in the proposal, recommended by any SEC after initial review of the proposal, in the subsequent meetings the committee shall deliberate the matter keeping in view the earlier decision/suggestion. The members should follow the Principle of Confidentiality with respect to the documents submitted by the applicants.


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