The Indian drug regulatory agency is gearing up to launch four big-ticket projects eyeing stricter regulations to improve drug manufacturing practices in India, News18 has learnt.
The four major projects that the Central Drugs Standard Control Organisation (CDSCO) plans to launch are the digital drug regulatory system, internal scientific cadre, Digital Indian Pharmacopiea and nationwide audits to check the adoption of Schedule M.
This year’s Union Budget reflects this commitment, with an increase in allocation specifically earmarked for strengthening state drug regulatory systems compared to the revised budgetary estimates of 2023-24.
For the fiscal year 2024-25, the budget has earmarked approximately Rs 75 crore to enhance state drug regulatory systems — marking an increase of over 40 per cent from Rs 52 crore allocated in the revised estimates for 2023-24. This allocation represents a significant rise compared to the Rs 22.87 crore designated in the budget 2022-23 for the same purpose — a jump of more than three times.
The move holds importance as, last year, the CDSCO came under scrutiny due to quality issues in Indian-made medicines flagged by global regulators like the World Health Organization. In response to numerous complaints from importers of Indian medicines, including The Gambia, Uzbekistan, and the United States, the health ministry and its regulatory arm intensified their efforts and implemented several measures to address these deficiencies.
How these four projects will help India
CDSCO will soon launch the Digital Drug Regulatory System which aims to develop a unified digital ecosystem. Once operational, all existing portals will be discontinued, and DDRS will serve as a single window for all regulatory activities.
According to CDSCO’s website: “This platform is envisioned to serve as a new approach to the regulatory system in the form of India’s DPI for regulatory systems, thereby ensuring quality medicines for India and the world.”
Also, the regulatory agency is working on the creation of an ‘internal scientific cadre’. It will help the agency to “improve internal decision making” and “improvement in subject understanding”, according to a document accessed by News18 describing the four big-ticket projects of CDSCO. It also lists “reduced turnaround time” as one of the benefits of having its scientific cadre.
The document also lists Digital IP or Indian Pharmacopiea. The government aims to launch this project in August with the objective of “easy accessibility, improved enforcement of quality standards”. It also aims to “increase the national and international reach of Indian pharmacopoeia”.
Also, the regulator is set to initiate audits of major pharmaceutical units to check their adherence to the updated Schedule M guidelines, which were announced at the beginning of the year. The department is ready with a list of more than 200 companies which will be conducted in sync with state offices.
Also, as CDSCO may soon add nutraceuticals under its ambit — which were previously monitored by food regulator FSSAI — the load on state regulators will go up.
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