To facilitate the availability and lower the cost of foreign manufactured drugs in India, the Central Government has waived the requirement for clinical trials to be held in that country if such drugs have been approved by the health regulators of USA, UK, Japan, Australia, Canada, or European Union countries.
For new drug categories to be considered for Indian market by The Central Government specified 5 categories. “The waiver will include medicines including vaccines falling under certain categories like orphan drugs for rare diseases; gene & cellular therapy products; new drugs used in pandemic situations; new drugs used for special defense purposes; and new drugs with significant therapeutic advances over current standard care,” a senior Health Ministry official said adding that other countries may also be included or removed from this list.
This follows an order of August 7 issued by India’s drug regulatory agency – Central Drugs Standard Control Organisation (CDSCO), which has authorised the exemption of local clinical trials as regards approval of new drugs ‘as per Rule 101’.
The report reads: “(the) Central Licensing Authority under Rule 101 of New Drugs and Clinical Trial Rules, 2019 with approval of Central Government may from time to time specify by order name of countries for considering waiver of local clinical trial for approval of new drugs under Chapter X and grant permission for conduct of clinical trial under Chapter V of the said rules’’.
However, according to another ministry official, this has been a long-standing demand both from pharmaceutical companies and health experts advocating improved drug accessibility for patients as well as research initiatives.
Further commenting on this statement Anil Matai, director general Organization of Pharmaceutical Producers Of India (OPPI) described this step as positive one forward that will help Indian manufacturers and foreign drug makers get government approvals quickly thereby ensuring fast access to vital medicines in India.
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“OPPI has been avidly supportive about this notification since we believe it can completely change the pharmaceutical and healthcare space in this country. These are for special defense purposes, new drugs used for pandemics, orphan drugs for rare diseases, gene and cell-based therapy products, and new drugs with significant therapeutic advance over the current standard care,” he said. “This strategic alignment is particularly crucial for accelerating access to innovative therapies to the patients in India.’’
However, as much as this group maintains that these waivers should be extended to more categories of treatment options, it is asking the Central Government to consider other areas in need of such waivers but could significantly impact on patient access.
