The government is developing a legislative overhaul to strengthen regulation across drugs, medical devices, and cosmetics. The proposed Drugs, Medical Devices and Cosmetics Act, 2025 is intended to replace the decades‐old 1940 Drugs and Cosmetics Act and introduce more stringent controls over the sector.
At a high‐level meeting chaired by the Health Minister, the Drugs Controller General of India (DCGI) presented a draft of the new law. The reforms aim to empower the Central Drugs Standard Control Organisation (CDSCO) with statutory authority, tighten market surveillance, and enhance accountability across the regulatory ecosystem.
Key features of the draft legislation include:
- Granting CDSCO the power for immediate enforcement actions against substandard, counterfeit, or falsified drugs and devices.
- Digitization of licensing processes to streamline approvals and oversight.
- Strengthened coordination between central and state regulators.
- Upgrading laboratory infrastructure and testing capacity to ensure robust quality control.
- Mandatory transparency and traceability throughout the manufacturing-to-market supply chain.
A key impetus behind the reform is growing concern over product safety. India has faced scrutiny following cases such as child fatalities from contaminated cough syrup in Madhya Pradesh.
According to CDSCO’s 2023–24 data, about 3.2% of around 5,500 tested drug samples were found substandard or spurious, leading to enforcement actions at over 40 manufacturing units in recent years.
The government is expected to introduce the bill in the upcoming Winter Session of Parliament. If enacted, the law would align India’s regulatory framework more closely with global standards, boosting confidence in pharmaceutical and device exports.
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