CDSCO to Start Quarterly Stakeholder Meets Under DCGI to Discuss Industry Concerns

According to a recent media report in The Economic Times, the meetings will be chaired by the Drugs Controller General of India (DCGI) and will bring together senior officials from the central drug regulatory authority, representatives of industry associations and other relevant stakeholders.

A senior regulatory official stated that the meetings are intended to provide a regular platform for stakeholders to raise regulatory concerns and facilitate greater coordination between the regulator and the industry.

“One of the aim of these meetings is to facilitate effective dissemination of recent regulatory developments and enhance transparency,” a senior regulator mentioned.

The initiative is scheduled to commence this month, with the first meeting expected to focus on the proposal of the Indian Council of Medical Research (ICMR) concerning the adoption of a single ethics committee review mechanism for multi-centre clinical trials.

The ICMR, the country's apex public health research organisation, had issued the draft guidance on the proposed framework in February this year.

The move has been welcomed by industry representatives, who said that regular and structured interaction with the regulator could help improve clarity and predictability in the regulatory process.

Commenting on the development, Anil Matai, Director General of the Organisation of Pharmaceutical Producers of India (OPPI), told ET, "Structured, recurring engagement of this kind strengthens the trust and as the industry invest in research-driven and innovative therapies, a predictable and collaborative regulatory dialogue is essential to align emerging science with regulatory expectations early, rather than navigating them in isolation."