India's Drug Regulatory Process 95% Digitised: Health Minister

The health minister also added that over 38 state drug regulator labs are functional across the country, and the use of barcodes and QR codes is now mandatory for the top 300 drug brands

Union Health Minister JP Nadda has recently announced that over 95% of India's drug regulatory processes have been digitized, enhancing transparency and efficiency in ensuring safe and effective drugs and medical devices.

The announcement was made at the 19th International Conference of Drug Regulatory Authorities (ICDRA) in New Delhi, hosted by the Central Drugs Standard Control Organization (CDSCO) in collaboration with the World Health Organization (WHO).

At the event, Nadda emphasized that India’s robust drug approval system tests over one lakh samples annually, ensuring affordable, quality medicines for both domestic use and export to over 200 countries.

Eight drug testing labs are operational, with two more in progress, along with eight mini-labs at ports to fast-track the testing of imported drugs and raw materials.

The health minister also added that over 38 state drug regulator labs are functional across the country, and the use of barcodes and QR codes is now mandatory for the top 300 drug brands and all active pharmaceutical ingredient (API) packs.

According to him, the CDSCO has aligned its drug regulations with global WHO standards.

“Considering the importance of medical devices in health care delivery, the medical device industry in India is also being regulated. Drugs Rules have been amended to make Good Manufacturing Practice Guidelines more comprehensive and at par with the WHO-GMP guidelines,” added the Minister.

Nadda further highlighted the importance of digitization in the drug regulatory process, which now covers 95% of operations, improving efficiency and trust among stakeholders.

The Union minister concluded his address saying, “We believe in 3 Ss i.e. “Skill, Speed and Scale” and by focusing on these three aspects, we have been able to meet the increasing demand for pharma products while adhering to global quality standards without any compromise. We are prepared to address pressing challenges, from antimicrobial resistance to ensuring equitable access to life-saving treatments. We are not just participants in this dialogue; we are partners in building a healthier, safer and more resilient world.”

Dr Tedros Adhanom Ghebreyesus, WHO Director-General, praised India’s leadership in global drug regulation, emphasizing the need for international collaboration to address challenges like antimicrobial resistance and AI in healthcare.

Sharing thoughts, Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India, said, “We are continuously upgrading our skills and capacities in our systems and are on a path towards low regulation and high execution”, he said.

The ICDRA conference is focusing on strengthening global regulatory systems through partnerships, with discussions on regulating medical devices, improving pharmaceutical standards, and addressing public health challenges such as COVID-19.

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