The Central Drugs Standard Control Organisation (CDSCO), India's drug regulatory body, is putting new tools into place to speed up decision-making to make clearance procedures for producers of pharmaceuticals and medical devices easier. According to media reports, the CDSCO has released draft guidance documents to improve communication between expert panels and applicants.

Under the proposed guidelines, subject expert committees (SECs) will be equipped with pre-drafted sets of 25 questions to be posed during meetings, ensuring a structured evaluation process for drug approval applications. This initiative seeks to establish clear criteria for evaluating applications and fostering transparent communication between regulatory authorities and industry stakeholders.

The SECs, comprising experts in relevant therapeutic areas, will be tasked with providing recommendations on applications on the same day as their meetings with applicants, significantly reducing the approval timeline. Furthermore, applicants may receive questions in advance, enabling them to prepare adequately for interactions with the expert panels.

According to reports, Industry insiders have welcomed the move, citing concerns over the clarity and relevance of questions posed by SEC members in previous interactions. Anonymously speaking to a media channel, a pharmaceutical industry veteran highlighted instances of ambiguous questioning and emphasized the need for a more focused approach.

Commenting on the draft guidelines, a representative from a Mumbai-based pharmaceutical company acknowledged the potential benefits of pre-drafted questions in maintaining discussion focus. However, they questioned the rationale behind requiring same-day recommendations, citing concerns over accurately reflecting discussions and minimizing inadvertent manipulation.

The draft guidance emphasizes the importance of briefing materials prepared by internal CDSCO divisions, ensuring that SEC members are adequately informed before meetings. These materials along with pre-drafted questions, will be shared with applicants in advance to facilitate transparent and balanced interactions.

The overarching goal of these measures is to establish a transparent and efficient evaluation process that addresses industry concerns while maintaining rigorous standards for drug and medical device approvals. By fostering clear communication and expediting decision-making, India aims to enhance its regulatory environment and support innovation in the pharmaceutical and healthcare sectors.