CDSCO To Launch Integrated Digital Drug Regulatory Platform In 18 Months

New Delhi, Jul 31 (KNN) India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), is set to roll out a new integrated digital platform aimed at modernising the country’s regulatory framework and simplifying compliance processes for the pharmaceutical industry.

Announcing the initiative at the Global Drug Regulatory Conclave 2026, Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi said the first phase of the Digital Drug Regulatory System (DDRS) will be operational within the next 18 months, ET reported.

End-to-End Digital Oversight

The proposed DDRS platform will function as a comprehensive, end-to-end system integrating all regulatory stakeholders—including manufacturers, distributors, and pharmacovigilance experts—into a unified interface.

It will enable regulators to track the entire lifecycle of pharmaceutical products, from initial filings and approvals to post-market safety surveillance. The system is also expected to improve coordination across different regulatory functions through enhanced interoperability.

Compliance Tracking and Transparency

A key feature of the platform will be visibility indicators that track companies’ compliance histories, including instances of Not of Standard Quality (NSQ) products and Good Manufacturing Practice (GMP) audit outcomes. This is expected to assist procurement agencies in making more informed decisions during tender evaluations.

For companies, the DDRS will act as a single-window interface for all regulatory requirements, significantly reducing paperwork and improving processing timelines.

AI Integration to Boost Efficiency

CDSCO is also piloting artificial intelligence tools and a digital ticketing system to automate reviewer allocation and pre-screen applications. These innovations are expected to cut first-response time by up to 80 per cent and overall processing time by around 40 per cent.

Referring to the time previously spent on obtaining clearances for registering products in overseas markets, the DCGI said, “Certificates of Pharmaceutical Product (CoPP) and cGMP certificates have now started being issued with QR codes to enable authentication and help exporters save up to six months.”

Global Collaboration and Standards

The conclave, organised by Pharmexcil in collaboration with CDSCO, brought together regulatory representatives from over 40 countries, including the US, UK, and Japan.

A major focus of the discussions was promoting global recognition of the Indian Pharmacopoeia (IP), which could help Indian pharmaceutical companies expand into new markets while lowering compliance costs.

Industry Outlook

Namit Joshi, Chairman, Pharmexcil, said, “As global expectations on quality and compliance continue to evolve, GDRC will help translate policy into consistent compliance across the industry, strengthening confidence in Indian pharmaceuticals across global markets,” as quoted by ET.

(KNN Bureau)