India, March 20 -- The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidelines outlining a dossier-based approach for issuance and renewal of drug manufacturing licences, aimed at ensuring uniform product licencing 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...