95% Regulatory Processes Currently Digitized at CDSCO: JP Nadda

Union Health Minister JP Nadda said that India rapidly expanded its healthcare infrastructure and scaled up vaccine production to meet both domestic and global demands.

New Delhi:Union Health Minister JP Naddaon Monday said that more than 95% regulatory processes currently have been digitized at Central Drugs Standard Control Organization (CDSCO), bringing transparency and increasing trust among stakeholders.

“CDSCO has developed robust systems for approving safe and efficacious drugs and medical devices in the country and for export to more than 200 countries in the world,” said Nadda while inaugurating the 19th International Conference of Drug Regulatory Authorities (ICDRA) here. CDSCO is India’s drug regulatory authority.

ICDRA is being hosted for the first time in India, bringing together regulatory authorities, policymakers, and health officials from over 194 WHO member states.

He said that the ICDRA platform provides a space to share knowledge, foster partnerships, and develop regulatory frameworks that ensure the safety, efficacy, and quality of medical products worldwide.

“During the unprecedented COVID 19 pandemic, India emerged not only as a global leader in health resilience and innovation but also reaffirmed its role as the Pharmacy of the World,” Nadda said.

He said that successful rollout of the COVID-19 vaccination program, covering over a billion people, is a testament to the robustness of our healthcare system, the dedication of our health workers, and the soundness of our policies.

The Union Health Minister highlighted that India played a crucial role in ensuring affordable access to essential medicines, vaccines, and medical supplies for nations across the globe. “Guided by the principle of ‘Vasudhaiva Kutumbakam’ – the world is one family, we extended our support to more than 150 countries, providing life-saving drugs and vaccines during the pandemic. This spirit of international solidarity is at the heart of India’s approach to global health. We believe that our progress is inseparable from the progress of the world, and as such, we remain committed to contributing to global health security and sustainability”, Nadda said.

Referring to the achievements of CDSCO, Nadda said that it has developed robust systems for ensuring availability of quality medicine at affordable price is at the core.

He also informed that eight drug testing labs are operational at present while two more are in pipeline.

“8 Mini testing Labs are operational at different ports for quick testing and release of drugs and raw material being imported. In addition, 38 State Drug Regulator’s Testing Labs are operational. Altogether, more than a hundred thousand samples are being tested every year under regulatory surveillance mechanisms,” Nadda said.

The minister stated that, “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.”

He said that in order to make the drug supply chain robust, it has been made mandatory to provide Bar Code or Quick Response Code (QR Code) on top 300 brands of drug products. “Similarly, QR Code is mandatory on all API packs, either being imported or manufactured in India,” he said.

Dr Tedros Adhanom Ghebreyesus, Director-General of WHO, commended India for hosting this crucial global regulatory forum and highlighted the importance of global cooperation in drug regulation, particularly in light of challenges such as antimicrobial resistance, the post-pandemic world, and the safe use of AI in healthcare.

“Global cooperation is important in drug regulation, particularly in light of challenges such as antimicrobial resistance, the post-pandemic world, and the safe use of AI in healthcare,” said Dr Tedros.

Union Health Secretary, Punya Salila Srivastava, said that the Indian pharmaceutical industry has recently become the 4th largest export sector of India, exemplifying the level of our integration into the global pharmaceutical supply chain.

“India is the third largest producer of pharmaceuticals in the world, and has the largest number of US FDA approved plants outside the USA,” she said.

Srivastava also highlighted that India supplies 50% of the world’s vaccines, most of them going to UN agencies like WHO, UNICEF and the Pan American Health Organization (PAHO) and to organisations like GAVI.