The Health Ministry’s draft amendments aim to cut regulatory delays, halve approval timelines, and boost innovation by allowing certain clinical trials and drug manufacturing to begin with just a notification to CDSCO.
With the government pushing for innovation and indigenous manufacturing in the pharmaceutical sector, the Union Health Ministry has proposed changes to the New Drugs and Clinical Trial Rules to ease regulatory approvals. The amendments would allow companies to conduct certain clinical trials and manufacture the drugs needed for these trials without seeking a license — the activities could begin after simply notifying the regulator.
Under the proposed rules, companies would be permitted to conduct some bioavailability or bioequivalence (BA/BE) studies without prior approval from the central regulator. These studies demonstrate that a new drug formulation is absorbed in the same way and produces results similar to a previously approved drug. However, this relaxation would apply only to oral formulations that have already been approved in countries with stringent regulatory systems — including the United States, European Union, United Kingdom, Japan, Australia, and Canada.
Trials without prior permission from the Central Drugs Standard Control Organisation (CDSCO) would not be allowed for:
* Any hormone therapy
* Narcotic or psychotropic drugs
* Drugs known to damage human cells
* Drugs with a narrow therapeutic index (i.e., those with a small difference between safe and harmful levels)
* Drugs with high variability in the concentrations that reach the intended site with a standard dose
The CDSCO will permit a trial to proceed after a simple notification only if it has been approved by an Ethics Committee registered with the CDSCO and involves a sample size of no more than 48 participants. The Ethics Committee must maintain documentation of its review and approval, which will be examined by the CDSCO during committee registration renewals. Most institutions conducting clinical trials already have such independent expert committees in place to oversee ethical compliance.
To begin a trial, companies would be required to complete an online form and receive an acknowledgment from the CDSCO.
Another proposed amendment would allow companies to manufacture new and unapproved drugs for these clinical trials under the same notification process. However, additional categories of drugs would be excluded from this route — including beta-lactam antibiotics (used to treat bacterial infections) and any product containing live microorganisms. These exclusions are in addition to those already outlined for clinical trial restrictions.
The proposal also halves the timeline for the full regulatory process — in cases where approval is still required — from the current 90 days to just 45 days.
“These proposed amendments will reduce the number of license applications being submitted by approximately 50%. This will facilitate quicker initiation of the BA/BE studies, testing and examination of drugs for research, and reduce delays in drug development and approval process,” the Health Ministry said in a statement.
This move aligns with a broader effort by the drug regulator to streamline the approval process. Last year, the Drug Controller allowed novel products to enter the Indian market without local clinical trials if they had already been approved in any of the six aforementioned countries with stringent regulatory mechanisms. While this helped fast-track access to new therapies in India — especially from global pharmaceutical companies — the latest amendments aim to benefit both international players and domestic innovators.
The government has been actively promoting research and innovation within India’s pharmaceutical industry, with the goal of not only manufacturing medicines for global markets but also developing new therapies for widespread use.
