New Drug Approvals Now 45 Days Faster – Health Ministry Eases Rules for Pharma
Health Ministry halves new drug review time to 45 days for faster approvals.
The Union Health Ministry on Wednesday notified significant amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at reducing regulatory hurdles and promoting ease of doing business in India’s pharmaceutical sector. The move is expected to accelerate clinical research, drug development, and generic drug manufacturing.
Under the amended rules, the review period for applications seeking permission to manufacture a new drug or investigational drug for clinical trials has been halved from 90 days to 45 days. This change will also apply to permissions for conducting bioavailability and bioequivalence (BA/BE) studies, allowing faster initiation of critical research.
The amendments replace the existing licensing requirement for non-commercial drug manufacture with a prior-intimation mechanism. Companies can now proceed with drug testing and development after submitting an online intimation to the Central Drugs Standard Control Organization (CDSCO), except for high-risk categories such as cytotoxic, narcotic, and psychotropic drugs. This is expected to substantially reduce procedural delays across the sector.
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For low-risk BA/BE studies, prior permission is no longer mandatory, and researchers can initiate studies based on simple online intimations. With CDSCO processing around 4,000–4,500 such applications annually, the new system will streamline approvals and enable quicker commencement of studies, particularly benefiting the generic pharmaceutical industry.
To ensure smooth implementation, dedicated online modules on the National Single Window System (NSWS) and SUGAM portal will allow stakeholders to submit intimations transparently and efficiently. The reforms are also designed to optimize CDSCO manpower and enhance the agency’s regulatory oversight capabilities.
The Health Ministry stated that these reforms reflect India’s commitment to R&D-led growth in the pharmaceutical sector, alignment with global regulatory standards, and strengthening the country’s position as a preferred destination for pharmaceutical research and development under the Jan Vishwas Siddhant and Ease of Doing Business framework.
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