Local Trials To Be Waived For Faster Access To New Drugs

NEW DELHI, 21 MARCH 2019: In a bid to give Indian patients faster access to new medicines that are not available in India, the government has decided to waive local clinical trials for new drugs which are approved and marketed in specific countries identified by the drug regulator.

The decision is part of new rules which are expected to be notified by the health ministry by the end of this week, official sources said.

For orphan drugs, used in the treatment of rare diseases, clinical trials in India will be waived if the drug is approved anywhere outside the country. Besides, companies may not have to pay an application fee for seeking approval to conduct clinical trials in India.

The other key provisions include fast-tracking of clinical trial approvals for other drugs within 30-90 days and statutory norms for payment of compensation in case of injury or death during trials.

Sources said the Drug Controller General of India can waive local clinical trials if the drug is already approved and being sold in the US, Japan, Australia, Canada and European Union.

Trials may also be waived for imported new drugs if the regulator had already granted permission to conduct a global clinical trial which is ongoing in India and has been approved for marketing in an identified country.

“The new rules will promote ethical and scientific research in India, while ensuring patient safety and faster accessibility of new drugs for the Indian population. These regulations will also bring predictability and transparency in the approval process of new drugs,” DCGI S Eswara Reddy told TOI.

The clinical trials market in India was estimated at $1.6 billion in 2017, growing at around 8.7% annually. While globalisation of clinical trials and growing disease variation and prevalence are anticipated to be some of the primary market drivers, the industry has suffered in the past few years in the absence of proper regulation and norms.

To address this gap, the Central Drugs Standard Control Organisation, which regulates the quality of medicines in India, had framed separate draft rules for clinical trials in February last year.

“After consulting various stakeholders and making changes accordingly, we have come up with the final rules which will guide clinical trials and new drugs going forward,” an official said.

So far, clinical trials were regulated under the Drugs and Cosmetics Rules. Once, the new notification comes into place, Clinical Trials and New Drug Rules, 2019 will be a separate vertical under the Drugs and Cosmetics Act, giving more teeth to the regulator to monitor research. The regulator has also recently carved out separate rules under the act for medical devices.The Times Of India