India Exempts Local Clinical Trials for New Foreign Drugs
Government Decision Streamlines Approval Process
Accessibility and Affordability Increased
The Indian government has announced a significant decision that will make drugs manufactured outside India more accessible and affordable in the local market. The government has removed the mandate for conducting local clinical trials for specific categories of drugs that have already been approved in countries such as the US.
This decision will streamline the approval process for new drugs, reducing the time and cost involved in bringing them to market in India. The waiver has been granted under Rule 101 of New Drugs and Clinical Trials Rules 2019, which allows the Drugs Controller General of India (DCGI) to exempt certain drugs from local clinical trials.
However, it's important to note that Rule 101 also allows the DCGI to specify certain countries for consideration of waiver. This means that not all foreign-made drugs will be exempt from local clinical trials, but only those from countries that meet specific criteria.
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