With pre-drafted list of 25 sample questions to be asked during the meeting, India plans to outline the criteria for experts to evaluate drug approval applications from pharmaceutical companies and medical device makers.
Extending a helping hand to pharma and medical device makers, the drug regulatory agency of India is smoothening the process of drug or medical device approvals, especially the interaction between the expert panel and applicants. The central government is making new draft guidance documents for subject expert committees, News18 has learnt. The drug regulator of India, the Central Drugs Standard Control Organisation (CDSCO), has rolled out a guidance document on procedures to be followed for evaluation of applications by the panel of experts.
The new rules may also allow sending questions to drug or device makers in advance for the scheduled subject expert committee meetings. Furthermore, these committees may now be tasked with submitting their recommendations on the same day following deliberations to expedite the approval process.
The eight-page long guidance document, seen by News18, drafts list of 25 questions to ensure balanced and proper interaction between pharma and medical device applicants and expert panel. The subject expert committees (SEC) consist of multiple experts in therapeutic areas in which the drugmaker is seeking approvals. For instance, the panel approving cancer drugs would consist of multiple experts on oncology.
The SEC helps advise the Drug Controller General of India (DCGI), head of CDSCO, in evaluation of multiple categories of applications received and processed in various divisions of CDSCO. The DCGI takes the final decision after considering all aspects, including the recommendations of the SECs. The draft says that the panel will be asked to give the recommendations on the same day of meeting the applicant. The document also says that the questions that the SEC plans to seek answers to should be sent to applicants in advance.
The move addresses industry concerns regarding panels’ unnecessary grilling and vague questioning. An industry veteran, speaking on condition of anonymity to News18, expressed annoyance over SEC panels posing irrelevant questions. They cited instances of panel members contradicting themselves and asking outlandish questions.
A Mumbai-based pharmaceutical company official commented on the draft questions in the new guidelines, noting that they will help maintain focus during discussions. However, he questioned the justification of requesting recommendations on the same day. “We have noticed issues with meeting minutes inaccurately reflecting discussions. I think same-day rule could relieve this problem by ensuring the freshness of the discussion and reducing the chance of inadvertent manipulation.”
SEC TO GET BRIEFING MATERIAL, PHARMA-DEVICE MAKERS TO GET QUESTIONS IN ADVANCE
The draft document says that the internal divisions in CDSCO should create crucial “briefing material” for the SECs after they receive the applications from the pharma companies. “The respective division will also prepare the broad questions to be placed before the committee for deliberation. The questions should be proper, balanced and based on the proposal of the applicant and the relevant regulatory provisions,” the document said.
The briefing material and the questions on each proposal, the document said, will be shared with the members of the SEC “well in advance”. These questions will also be shared with the pharma companies or medical device makers before the meeting so that they can prepare themselves to present their proposals before the committee.
HOW SEC CAN BE MORE PRODUCTIVE: DOCUMENT DESCRIBES
The idea behind the rule is a “proper, balanced and transparent manner for ensuring effective performance of the committee and the applicant”. The draft documents suggest that the panel should have a “robust evaluation process ensuring proper, balanced, consistent and transparent interaction with the applicants”.
For effective performance of a committee meeting, the document briefs that the presentation of proposals should be “clear, scientifically valid, proper, balanced and transparent”. It states that the “tone of the committee” interaction with the applicant as well as deliberations by the committee is “set properly.” It also said that the committee discussion and deliberation time is “protected” along with “assurance of sufficient coverage of relevant issues.”
The document mandates that after the presentation and interaction with the applicant, the SEC members will deliberate on the proposal and provide recommendations on the proposal with reason on the same day.
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