Health Ministry Notifies Amendment To NDCT Rules To Ease Regulatory Burden, Ease Of Doing Business

By Gautam Debroy

New Delhi: The Union Health Ministry on Wednesday notified key amendments to New Drugs and Clinical Trials (NDCT) Rules, 2019 to reduce regulatory burden and promote ease of doing business.

In a gazette notification amending the NDCT Rules, 2019, the ministry said the review period for applications seeking permission to manufacture a new drug or an investigational new drug for clinical trials, or to conduct bioavailability or bioequivalence (BA/BE) studies, has been reduced from 90 days to 45 days.

“These amendments are aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharmaceutical development in the country,” a health ministry spokesperson said.

No need to wait for test licenses

Under the new amendment, the present system for test licenses has been converted to a notification and intimation system. Through this, the applicants need not wait for test licences (except a small category of high-risk category drugs) but will need to just intimate the central licensing authority. Additionally, the overall statutory processing time for test licence applications will be reduced from 90 days to 45 days.

The existing regulations

Under the existing regulatory framework, pharmaceutical companies are required to obtain a test licence from the Central Drugs Standard Control Organization (CDSCO) for manufacture of small quantities of drugs intended for examination, research, or analysis purposes.

However, through the notified amendments, the licencing requirement for non-commercial manufacture has been replaced with a prior-intimation mechanism. As a result, the industry will no longer be required to seek a test licence and may proceed with pharmaceutical development upon submitting an online intimation to CDSCO, except in the case of a limited category of high-risk drugs, including cytotoxic drugs, narcotic drugs, and psychotropic substances.

Considering that CDSCO processes approximately 30,000 to 35,000 test licence applications annually, the reform is expected to substantially reduce regulatory burden and benefit a large number of stakeholders.

Bioavailability/Bioequivalence (BA/BE) study applications

Under the new amendment, the existing licence requirement will be dispensed with for certain categories of BA/BE studies, which may instead be initiated upon submission of an intimation or notification to the central licensing authority.

Bioavailability (BA) refers to the relative amount of drug from an administered dosage from which enters the systemic circulation and the rate at which the drug appears in the systemic circulation. Bioequivalence (BE) of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.

These regulatory reforms are expected to benefit stakeholders by significantly reducing the timelines for processing applications. These proposed amendments will reduce the number of license applications being submitted by approximately 50 percent.

“This will facilitate quicker initiation of BA/BE studies, testing and examination of drugs for research, and reduce delays in the drug development and approval processes,” Dr Giuridhar Gyani, director general of Association of Health Care Provider-India (AHCPI) told ETV Bharat.

Studies to be initiated on basis of an online intimation to CDSCO

Bioavailability/Bioequivalence (BA/BE) studies may now be initiated on the basis of a simple online intimation to CDSCO, enabling faster commencement of studies, particularly for the generic pharmaceutical industry. CDSCO processes around 4,000 to 4,500 BA/BE study applications every year, and the revised mechanism is expected to significantly reduce procedural delays.

To ensure smooth and seamless implementation of these changes, dedicated online modules will be made available on the National Single Window System (NSWS) and the SUGAM portal, allowing industry to submit intimations in a transparent and hassle-free manner.

Ethics Committee

Earlier, under the NDCT Rules, an Ethics Committee is required to be set up and registered to conduct clinical trials or bioavailability studies or bioequivalence studies. The study and trial can be conducted only with the approval of this Committee, whose registration with the Central Licensing Authority will be valid for a period of five years.

In case of any serious adverse event during a clinical trial or bioavailability or bioequivalence study, the Ethics Committee is required to analyse the relevant documents pertaining to such an event and forward its report to the Central Licensing Authority.

Overall benefits

The amendments will enable the Central Drugs Standard Control Organization (CDSCO) to optimise the deployment of its human resources, thereby enhancing the efficiency and effectiveness of regulatory oversight.

Overall, these regulatory reforms are expected to provide substantial benefits to stakeholders while ensuring public health and safety. By significantly reducing timelines for regulatory processing, the amendments will facilitate quicker initiation of BA/BE studies, testing, and examination of drugs for research purposes, and minimise delays across the drug development and approval continuum.

“The reforms will also enable the Central Drugs Standard Control Organization (CDSCO) to optimise utilisation of its existing manpower, thereby enhancing the efficiency and effectiveness of regulatory oversight,” a health ministry spokesperson said.

These measures underscore the Government of India’s commitment to continuous, trust-based regulatory reforms in the pharmaceutical sector, in line with the Jan Vishwas Siddhant and the broader Ease of Doing Business framework.

The initiative aims to promote R&D-led growth of the Indian pharmaceutical industry, align domestic regulations with global best practices, and strengthen India’s position as a preferred global destination for pharmaceutical research and development, the health ministry spokesperson stated.

Health ministry seeks public opinion

Earlier, the health ministry has sought public opinion on the new amendments. In fact, in August last year, the health ministry had published the proposed amendments in the Gazette of India on August 28, seeking public comments within 30 days.

'NDCT amendments are useful'

Talking to ETV Bharat, renowned health expert and past president of Asian Society for Emergency Medicine Dr Tamorish Kole said that from a clinician’s perspective, these NDCT amendments are useful and largely welcome, even if their benefits are indirect.

“By reducing regulatory delays—especially for low-risk drug development and BA/BE (Bioavailability and Bioequivalence) studies—they can speed up the availability of quality generics, reformulations, and incremental innovations that directly affect day-to-day patient care in India,” he said.

Dr Kole said that the shift to a trust-based, prior-intimation model aligns with global best practices while appropriately retaining safeguards for high-risk drugs.

“The real clinical value will depend on robust implementation, ethical oversight, and strong pharmacovigilance, but if done right, this reform should translate into faster access, better affordability, and wider therapeutic options for patients,” he said.

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