The Central Drugs Standard Control Organisation has introduced a dossier-based approach for drug manufacturing licences to ensure uniform product licensing and quality standards nationwide.
The new guidelines, released last month, streamline the application process for manufacturers by using a structured checklist covering administrative and technical requirements.
This approach enables regulators to undertake a comprehensive evaluation of applications, including test reports, certificates, and supporting documents, promoting transparency and fairness in the decision-making process.
The initiative follows deliberations at the 61st meeting of the Drugs Consultative Committee, where concerns over drug quality, safety, and efficacy were raised.
State regulators have agreed to implement the framework to achieve uniformity in documentation and evaluation processes for granting manufacturing licences.
The move aims to address long-standing issues related to drug quality and promote a more robust and transparent regulatory environment in India's pharmaceutical sector.
