In a decision that would make drugs manufactured outside India more accessible and affordable in the local market the Central government has decided to waive the requirement for clinical trials in India if the drugs are approved in the United States, United Kingdom, Japan, Australia, Canada, and European Union.
The Central Government has specified a set of five categories for new drugs that will be considered for the Indian market. “Drugs including vaccines that fall in the category -- orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, new drugs used for special defence purposes, and new drugs having significant therapeutic advances over the current standard care – will be considered under the waiver,” said a senior Health Ministry official, adding that names of the countries on the current list can be added or taken off.
According to an order issued on August 7 by India’s drug regulatory agency, Central Drugs Standard Control Organisation (CDSCO), the Central Government has authorised the exemption of local clinical trials for approval of new drugs, ‘as per Rule 101’.
“As per Rule 101 of New Drugs and Clinical Trial Rules, 2019 the Central Licensing Authority, with approval of the Central Government, may specify by an order, the name of the countries from time to time for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V of the said rules,’’ reads the order.
Meanwhile, another official at the Health Ministry noted that the order has been a long standing demand of the pharmaceutical companies and health experts who have been advocating for enhanced drug accessibility for patients and for research.
Anil Matai, director general, Organisation of Pharmaceutical Producers of India (OPPI) reacting to the announcement said that this a welcome and progressive move that will significantly benefit both domestic and foreign drug manufacturers by expediting the approval process and facilitating faster access to essential medications for Indian patients.
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“OPPI has been advocating for this notification, recognising its potential to transform both the pharmaceuticals, and the healthcare landscape in India. The inclusion of specific categories such as orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, those for special defense purposes and new drugs with significant therapeutic advance over the current standard care would address critical and unmet medical needs. This strategic alignment is particularly crucial for accelerating access to innovative therapies to the patients in India,’’ he said.
The group has, however, maintained that extending these waivers to a broader range of therapeutic categories will further enhance access to cutting-edge treatments. It has asked the Central Government to consider additional therapeutic areas where similar waivers could significantly impact patient access.
