Drug maker Hetero Labs had recently approached the drug regulatory authority for waiving of local clinical trials so as to introduce the generic version of Gilead’s long acting HIV drug.
However, the same was rejected by the expert committee under the drug regulator-which means that the company will have to conduct Phase III trials resulting in a significant delay to launch the affordable treatment.
Last year, half a dozen drug makers including four Indian companies entered into non-exclusive, royalty-free licensing agreements with the drug’s developer, Gilead Sciences, to manufacture generic versions of lenacapavir and market it locally and in 120 low- and middle-income countries.
Permission Denied India rejects clinical trial waiver, blocks fast-track route to lenacapavir
Chetali Rao, Sr. Scientific Researcher & Legal Advisor at the Third World Network, said the local trials will add “little scientific value” while costing “precious years” in the growing HIV epidemic.
“Lenacapavir is the first twice yearly HIV prevention injection to be approved by major global regulators and recommended by WHO, yet India is insisting on duplicative trials,” she said. “The New Drugs and Clinical Trials Rules explicitly allow waivers where strong foreign data exist and a serious public health need is clear. India must adopt a science based approach to lenacapavir’s regulatory approval, using robust global evidence and focused local pharmacovigilance rather than delaying access through redundant and unethical Phase III requirements.”
Raising its concerns, the Third World Network (TWN) has written to the drug regulator and sought reconsideration and clarification regarding the recent decision of the Subject Expert Committee SEC).The Company had presented its proposal for permission to manufacture and market lenacapavir 300 mg tablets, along with a justification for waiver of the local Phase III clinical trial and BE study, and the Committee, after deliberation, did not recommend for BE waiver and local Phase III CT waiver, said the minutes of the meeting.”We fully appreciate the Committee’s responsibility to safeguard patient safety and ensure robust evidence for Indian populations. At the same time, we are deeply concerned about the public-health implications of delayed access to lenacapavir, particularly in light of the urgent and unmet need for new options for HIV prevention and treatment in India,” the letter dated Nov 25 said.
Earlier last year, half a dozen drug makers including four Indian companies entered into non-exclusive, royalty-free licensing agreements with the drug’s developer, Gilead Sciences, to manufacture generic versions of lenacapavir and market it locally and in 120 low- and middle-income countries.
While Gilead had filed patents widely on the drug, the voluntary licence was meant to overcome the patent barriers for sale in the identified low- and middle-income countries.
