Guidance document on procedures to be followed For Evaluation of applications By The subject expert committees

'The robust evaluation process is critical for effective and efficient review of all applications. The review process involves evaluation of safety and efficacy, quality data, and other related information for approval of new drug or biological drug product, medical device, and post-marketing phase assessment. Different categories of applications include Investigational New Drug (IND), New Drug, Fixed Dose Combination, rDNA Derived Product, vaccines, Global Clinical Trial, Bioavailability & Bioequivalence (BA/BE) study, New Medical Devices, etc.

To address the challenges raised by stakeholders, a guidance document outlines procedures to be followed by all concerned for efficient valuation of applications. The procedures include preparing briefing material and broad questions for each proposal, sharing them with SEC members and applicants in advance, and ensuring proper, balanced, transparent interaction during the meeting.

During the meeting, the applicant makes their presentation focusing on the questions already forwarded to them in advance. The interaction between SEC members and applicants is focused on addressing the questions raised on the proposal. After the presentation, the SEC members deliberate the proposal with involvement of all members present in the meeting, providing a recommendation on the proposal with reason on the same day.

Broad questions for ensuring effective, balanced, and proper interaction between committee members and applicants include questions such as: What efficacy data are necessary to evaluate the drug for treatment? What safety data are necessary to evaluate the risk of the drug when used for an indication? Whether active comparator arms should be included in clinical trials? Do the data presented support approval of the new drug vaccine/medical device/new indication/dosage form/strength/modified release form/NDDS/pack size of the drug?

The guidance document aims to provide a robust evaluation process ensuring proper, balanced, consistent, and transparent interaction with applicants and deliberation by expert members for evaluation of various proposals.'