New Delhi: In India, initiating development of a new drug may no longer need clearance from the drug regulator. Instead, it can now begin with an online intimation.
The Union health ministry Tuesday notified changes to the New Drugs and Clinical Trials (NDCT) Rules, 2019, removing the need for test licences for non-commercial drug manufacture and easing rules for testing, research, or analytical purposes. The changes, said the ministry, are aimed at reducing delays and expediting research on new drugs.
Under the earlier rules, drugmakers had to get a test licence from the Central Drugs Standard Control Organisation (CDSCO)—the national regulator for pharmaceuticals, medical devices, and cosmetics—to manufacture small quantities of drugs for research, examination or analysis. The new rules replace this with a “prior-intimation mechanism”.
Drugmakers can now begin work after submitting an online intimation to CDSCO.
“This reform is expected to lead to a minimum saving of 90 days in the drug development life cycle, providing a significant boost to pharmaceutical research and innovation,” the ministry said in a press statement Wednesday.
India is a major supplier of generic medicines and vaccines worldwide.
Government estimates put it third in production volume and 14th in value, with a vast network of more than 3,000 firms, 10,500 factories, and 60,000 generic brands. Exported to more than 200 countries, 60 percent of these medicines reach markets with strict regulations, with the US accounting for 34 percent and Europe 19 percent of exports.
Drugmakers have, however, often pointed to slow regulatory processes as a hurdle to quicker research which could allow them to match pace with international competitors. Latest changes to the NDCT Rules aim to address these concerns.
But the relaxation does not apply to some categories of drugs. Cytotoxic drugs, narcotic drugs and psychotropic substances will still need licences owing to safety concerns.
Cytotoxic drugs are used to kill or damage rapidly dividing cancer cells in treatments like chemotherapy. Narcotic drugs help relieve severe pain but can be addictive; examples include pain relief drugs like morphine and codeine. Psychotropic substances affect the mind, mood, or behavior, such as antidepressants, antipsychotics, or sedatives. Owing to their potential for harm, misuse, or side effects, all three categories continue to require special licences for manufacturing, distribution, and use.
For cases where test licences continue to apply, the government has shortened timelines. The CDSCO will now have 45 days to process applications instead of 90, the ministry said.
The regulator handles around 30,000 to 35,000 such applications every year, and the ministry said the shorter window should reduce delays for companies and workload for the regulator.
In another attempt to speed up clinical research, the government has removed the need for prior approval for some low-risk BA/BE (Bioavailability and Bioequivalence) studies.
These studies check whether a generic drug works in the same way as an already approved medicine. Earlier, many BA/BE studies needed prior permission from The CDSCO. The amended rules waive this requirement for specified low-risk studies. Companies can now begin these studies after sending an online intimation.
According to the ministry, CDSCO processes around 4,000 to 4,500 BA/BE applications annually. “Such 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,” it said.
To put the new system in place, the government plans to launch online modules on the National Single Window System (NSWS) and the SUGAM portal. These platforms will be used for receiving intimations and are meant to make the process digital and trackable.
The ministry said the latest changes will also help the regulator “to optimise utilisation of its existing manpower”.
(Edited by Amrtansh Arora)
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