New Delhi, March 19 The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidelines outlining a dossier-based approach for issuing and renewing drug manufacturing licenses, aimed at ensuring uniform product licensing and quality standards.
The document, released last month, seeks to streamline the application process for manufacturers by introducing a structured checklist covering administrative and technical requirements. It applies to pharmaceutical manufacturers but excludes AYUSH drugs, cosmetics, and medical devices.
According to the guidance document, dossier-based licensing enables regulators to undertake a "structured and comprehensive evaluation" of applications, including test reports, certificates, and supporting documents, rather than relying on individual assessments.
"The dossier-based approval process promotes transparency and ensures fairness in the decision-making process. The dossier-based approach is more efficient than individual evaluation as it streamlines the process and reduces the need for redundant assessment," the document said, adding that this approach is helpful when objective and consistent evaluation is necessary.
The initiative follows deliberations at the 61st meeting of the Drugs Consultative Committee, where concerns over the quality, safety, and efficacy of drugs, as well as the need for uniform implementation of regulatory provisions, were raised.
The committee recommended the implementation of the dossier/document-based licensing system for drugs across the country, stressing the need for nationwide adoption of a standardized checklist for licensing.
The guidance document divides submission requirements into two parts – Part A covering firm and facility-related details such as site plans, staff qualifications, and regulatory approvals, and Part B focusing on product-specific data including stability studies, process validation, and bioequivalence reports.
Officials said the checklist is designed to bring "credibility and predictability" to the regulatory system and assist both applicants and state licensing authorities in ensuring compliance with the Drugs and Cosmetics Act and Rules, 1945.
All state regulators have, in principle, agreed to implement the framework to achieve uniformity in documentation and evaluation processes for granting manufacturing licenses following discussions in a meeting of drug regulatory authorities on August 29, 2023, at the CDSCO headquarters, the document noted.
CDSCO sources said the move will help address long-standing issues related to drug quality and promote a more robust and transparent regulatory environment in India's pharmaceutical sector.