India Set To Halve Time For Drug Trial Nod, Endorse Major Overseas Approvals

(MENAFN- Live Mint)

New Delhi: In a move that will overhaul the process for drug trials in India, the health ministry has drafted rules that aim to halve the approval time for new drugs and clinical testing. The proposal aims to accelerate innovation in pharmaceuticals, give patients a quicker access to medicines, and expand India's footprint in the $1.55 billion global clinical trials industry.

In a press statement on Wednesday, the health ministry said it is amending the New Drugs and Clinical Trials Rules, 2019, to promote ease of doing business. The proposed changes will streamline the process for testing licenses and certain studies by replacing the old licensing system with a faster online notification system. This is expected to reduce application processing times by half, from 90 to 45 days, it said.

"The proposed amendments will reduce the number of license applications being submitted by approximately 50%," the ministry said. The draft notification has sought public comments within 30 days.

The draft New Drugs and Clinical Trials (Amendment) Rules, 2025, seeks to overhaul the regulatory framework by cutting red tape for drug companies. The draft rules call for a new, simplified notification system for companies making or conducting research on new drugs. So, for many drugs, companies will no longer need to go through a long approval process; they can start manufacturing after an online notification is sent and acknowledged by the Central Licensing Authority.

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The existing rules for patient safety will, however, will stay under the new norms and this quick process will not apply to certain categories of drugs considered high-risk, such as sex hormones, cytotoxic drugs and narcotics.

To boost India's pharmaceutical exports, the ministry has proposed a fast-track online notification system for certain studies on drugs. This applies to bioavailability and bioequivalence studies that are crucial to prove a drug's effectiveness. Bioavailability refers to how well the active part of a medicine is absorbed by the body, while bioequivalence compares two similar drugs to ensure they have the same effect.

One of the key changes proposed allows companies to start studies on drugs meant for export with a simple online notification, provided the product has already been approved in major international markets like the US, UK, EU, Japan, Australia and Canada. These studies will be limited to a maximum of 48 healthy adult volunteers.

In India, after successful trials, a company submits a new drug application to the Central Drugs Standard Control Organization. If approved, the drug receives a licence for sales.

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The proposed changes have been welcomed by leaders in the pharmaceuticals sector. They underscore the government's commitment to easing business and encouraging research and development, said Sheetal Arora, chief executive officer of Mankind Pharma Ltd. "The move will remove obstacles that have long slowed down crucial drug development, leading to faster innovation for patients and better business conditions," she said.

Nikkhil K. Masurkar, the chief executive officer of Entod Pharmaceuticals, said the draft rules mark a decisive step toward establishing India as a global pharmaceutical hub.“The new online notification system for studies already approved in other major markets will help align the country's practices with global standards, benefiting both local and international partners. The new rules are seen as a clear sign of India's commitment to regulatory excellence and patient-focused drug development," Masurkar added.

India's clinical trial market, valued at $1.55 billion in 2024, is projected to reach $3.38 billion by 2034, driven by cost-effectiveness and its large patient population. The country currently accounts for 8% of global clinical trial activity, according to Nova One Advisor, IMARC Group. The US is the global leader in the sector, followed by the major markets in Europe and China.

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