Government announces waiver for several drugs approved from select countries
Indian government removes clinical trial requirement for some imported drugs
The new policy aims to make high-end medicines more accessible and affordable in India.
In a move that could make drugs manufactured outside India more accessible and affordable, the government has waived the requirement for clinical trials of certain categories of drugs in India if they have already been approved in select countries.
The decision, announced on August 8, 2024, applies to high-end anti-cancer, anti-obesity, and anti-rare disorder drugs. These drugs are often prohibitively expensive in India, and the clinical trial requirement has further delayed their availability to patients.
The government's decision has been welcomed by experts, who say it will make these life-saving drugs more accessible to those who need them.
Here are some of the key details of the new policy:
- The waiver applies to drugs that have been approved by regulatory agencies in the United States, the United Kingdom, Canada, Australia, and Japan.
- The drugs must be manufactured in a facility that is certified by the Good Manufacturing Practices (GMP) standards of the respective country.
- The waiver will be granted on a case-by-case basis, and the government will consider factors such as the availability of the drug in India, the unmet medical need, and the cost of the drug.
The government's decision is a significant step towards making healthcare more affordable and accessible in India. It is hoped that the new policy will lead to a wider availability of high-end drugs and help to improve the lives of patients.
For more information, please visit the website of the Ministry of Health and Family Welfare.
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