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India waives local clinical trials for certain drugs approved in well-regulated markets
According to the government’s order, the waiver currently applies to specific categories, including orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, treatments for special defense purposes, and new drugs offering major therapeutic advancements over existing standards of care, particularly for addressing critical and unmet medical needs.
- By Newsdesk
- New Delhi
- Aug 09, 2024
The Ministry of Health and Family Welfare announced on Thursday a significant policy change that could streamline the introduction of new drugs into the Indian market. The ministry has decided to waive the requirement for local clinical trials for certain drugs that have already received approval in well-regulated markets, such as the United States, the United Kingdom, Australia, Canada, Japan, and the European Union. Despite this waiver, a subject expert committee will still evaluate whether these drugs offer superior therapeutic benefits compared to existing treatments available in India.
This decision follows a government order issued on August 7, which eliminated the local clinical trial requirement for these pre-approved drugs. Health ministry officials believe that this change could potentially save three to four years in the drug approval process, facilitating quicker access to essential medications.
A senior health ministry official emphasized that the new rule is designed to make essential drugs with significant therapeutic advancements more readily available to Indian patients. Under this regulation, the central drug regulatory body will grant full approval to these drugs, rather than merely providing emergency use authorization. This approach simplifies the approval process for critical drugs and innovative treatments already accessible in Western markets.
Anil Matai, Director General of the Organisation of Pharmaceutical Producers of India (OPPI), expressed strong support for the new policy. He noted that it would expedite the approval process, benefiting both domestic and international pharmaceutical companies and improving access to vital medications for Indian patients.
OPPI, representing multinational pharmaceutical companies in India, has also encouraged the government to broaden these waivers to include a wider range of therapeutic categories, further enhancing access to state-of-the-art treatments.
According to the government’s order, the waiver currently applies to specific categories, including orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, treatments for special defense purposes, and new drugs offering major therapeutic advancements over existing standards of care, particularly for addressing critical and unmet medical needs.
Ruchi Sogarwal, Head of Corporate Affairs at Takeda Biopharmaceuticals India, highlighted the positive impact of this decision on patients, noting that the selected categories target areas with high unmet medical needs. She added that accelerating the regulatory process for these therapies could significantly benefit patients and communities.