Over 95 per cent regulatory processes currently have been digitized at CDSCO, bringing transparency and increasing trust among stakeholders, said JP Nadda, Union Minister of Health and Family Welfare on Monday.
While speaking at the inauguration of 19th International Conference of Drug Regulatory Authorities (ICDRA) here, he said, “Considering the importance of medical devices in health care delivery, 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.”
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It was also pointed out that in order to make 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.
Noting 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,” he highlighted CDSCO’s achievements, saying that “it 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”.
Availability of Quality medicine at affordable price is at the core, he said, informing that “8 drug testing labs are operational today while 2 more are in pipeline. Eight 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 mechanism, Nadda told.
Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO, also addressed the gathering and 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.
The event is being hosted for the first time in India, from 14th – 18th October by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, in collaboration with the World Health Organization (WHO) brought together regulatory authorities, policymakers, and health officials from over 194 WHO member states.
