Rejection of trial waiver for Hetero's lenacapavir will impact India, LMICS: TWN

THE decision of the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to reject Hetero Lab's request for waiver of two studies for the manufacturing and marketing of generic lenacapavir 300 mg tablet will impact the accessibility of the generic equivalent of Gilead's HIV drug in India and the low-and-middle income countries (LMICs), according to an independent nonprofit international research and advocacy organisation.

- Our Bureau, New Delhi

The SEC of the Central Drugs Standard Control Organisation (CDSCO) had turned down Hetero's application for grant of permission to manufacture and market long acting lenacapavir 300mg tablet. The minutes of the meeting note that Hetero's proposal was supported by justification for waivers for a phase III (local) clinical trial and for a bioequivalence (BE) study. Hetero is among the six generic manufacturers that have been provided a royalty free voluntary license by Gilead Sciences to make and sell generic lenacapavir.

"In the absence of a waiver, the timeline for introduction of generic lenacapavir in India will now be extended. Access delays will not only affect India but a large cohort of low-and-middle income countries (LMICs) covered under Gilead's license - many of which depend on Indian generics for their supply," said the organisation.

"Granting this waiver would not only have expedited access to lenacapavir for India's 2.3 million PHLIV population but also positioned India as a global supplier, averting delays in LMIC rollouts. This regulatory hurdle postpones the potential public health benefits that timely, affordable generic lenacapavir could offer," it added.

The Rule 75 of the New Drugs and Clinical Trials Rules (2019) provides that the local clinical trial may not be required to be submitted along with the application referred to in sub-rule (1) if, the new drug is approved and marketed in countries specified by the Central Licencing Authority under rule 101 and if no major unexpected serious adverse events have been reported.