Digitisation at drug regulator speeds up approvals, says DCGI

DCGI Rajeev Raghuvanshi on Wednesday said the launch of digital dashboards in the review process of medical drugs carried out by the Central Drugs Standard Control Organisation (CDSCO) has drastically reduced the drug approval timelines.

The update was shared by the DCGI during a follow-up meeting on ‘Transforming the regulatory ecosystem of the medical products in India’, chaired by Ajay Kumar Sood, Principal Scientific Adviser (PSA) to the Government of India, on Tuesday.

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He noted that the review process for the application of Global Clinical Trials for Cell and Gene Therapy has drastically dropped from 226 days to 40 days in the last two years, between 2022 and 2024. Likewise, there is a drastic decline in the timelines for modifications of cell and gene therapies, post-approval. Earlier, in 2022, such processes would take 218 days, which can now be completed in 98 days. Raghuvanshi attributed the speeding up of these processes to the roll-out of digital dashboards.

Applauding the State Drug Regulatory Index — an evaluation system for examining the performance of drug regulators in each state, launched last week, Sood said, “Such competitive benchmarking would draw all States into the system and significantly raise the overall standard of drug regulation in India.”

According to an official statement, CDSCO has also created a harmonised national database that unifies the analysis processes for the certification of Pharmaceutical Products as per the World Health Organisation (WHO) standards. The Drug Controller General also highlighted that the CDSCO has prepared the biosimilar guidance, in line with global standards, facilitating enhanced access to biologics— a class of medicines derived from living organisms or their components, such as cells, proteins, or nucleic acids, to treat diseases, in the country.