CDSCO to hold quarterly stakeholder meetings to discuss regulatory framework and procedures

The Central Drugs Standard Control Organisation (CDSCO) will organise quarterly stakeholder meetings under the chairmanship of the Drugs Controller General of India (DCGI) to discuss regulatory developments, implementation issues and procedures.

According to an office order issued by CDSCO on 6 August 2026, the initiative aims to strengthen stakeholder engagement, enhance transparency, improve regulatory compliance and facilitate the dissemination of regulatory developments and stakeholder expectations on regulatory updates.

The first meeting is scheduled for 24 August 2026 from 2:30 pm to 5:00 pm at the second floor of CDSCO headquarters at FDA Bhawan, New Delhi.

According to CDSCO, the meetings will provide a platform for interaction between the regulator and stakeholders, including discussions on regulatory updates, implementation issues, regulatory procedures and feedback from industry and other stakeholders.

CDSCO has asked 12 industry associations to nominate not more than two representatives, comprising the president or chairman and secretary or general secretary, or a senior representative, to participate in the meeting with the DCGI. The associations include the Indian Drug Manufacturers’ Association (IDMA), Organisation of Pharmaceutical Producers of India (OPPI), Bulk Drug Manufacturers Association (India) [BDMA(I)], Federation of Pharma Entrepreneurs (FOPE), Indian Pharmaceutical Alliance (IPA), Federation of Indian Chambers of Commerce and Industry (FICCI), Confederation of Indian Industry (CII), Indian Vaccine Manufacturers Association (IVMA), Himachal Drug Manufacturers Association (HDMA), Laghu Udyog Bharati (LUB), Indian Federation of Animal Health Companies (INFAH) and Veterinary Vaccine India Manufacturers Association (VVIMA).

The nominated representatives’ names, designations, email IDs and contact numbers, along with brief discussion points not exceeding one page, are to be submitted to CDSCO by 12 August 2026. CDSCO stated that invitations will be issued in the names of the nominated representatives and only those representatives will be permitted to attend the meeting. Subject experts from the respective associations may attend with prior permission.

Reacting to the development, Harish Jain, President, Federation of Pharma Entrepreneurs (FOPE), states: 

“ FOPE welcomes the CDSCO’s initiative to institutionalise Quarterly Stakeholder Meetings under the chairmanship of the Drugs Controller General of India. This is a significant step towards making regulatory engagement more structured, transparent and responsive.

For the pharma industry, particularly MSMEs, timely clarification on regulatory requirements and a predictable implementation framework are extremely important. A regular institutionalised dialogue will help identify practical challenges at the ground level, reduce avoidable ambiguity and facilitate smoother compliance.

FOPE looks forward to using this platform constructively to present the concerns and suggestions of pharma entrepreneurs and to work closely with CDSCO in strengthening India’s regulatory ecosystem. We believe that effective regulation and ease of doing business must go hand in hand, with patient safety and quality remaining paramount.

We appreciate the DCGI for creating this forum for continuous stakeholder engagement and look forward to making these quarterly interactions meaningful and outcome-oriented.”

Anil Matai, Director General, OPPI:

“ OPPI warmly welcomes CDSCO’s initiative to institutionalize Quarterly Stakeholder Meetings under the chairmanship of the Drugs Controller General (India). Structured, recurring engagement of this kind strengthens the trust and transparency that must underpin India’s regulatory ecosystem. As the pharmaceutical industry continues to invest in research-driven and innovative therapies to meet evolving patient needs, a predictable and collaborative regulatory dialogue is essential — it allows industry to align emerging science with regulatory expectations early, rather than navigating them in isolation. We look forward to constructive discussions with CDSCO and believe this platform can meaningfully accelerate the translation of innovation into accessible healthcare solutions for patients across India.”