Gilead’s remdesivir now part of India’s Covid treatment protocol, but licences for 5 firms are stuck in red tape

The Indian Express
14 June 2020
Written by: Prabha Raghavan

It is unclear though how many firms with voluntary licences from Gilead have received the drug regulator’s go-ahead to manufacture and supply remdesivir in India.
The government on Saturday released guidelines for doctors to use investigational antiviral medication remdesivir in treating India’s Covid-19 patients, but there is still little clarity on how patients can access the drug.
Health activists and industry sources allege “not a single” vial of the drug has been brought into India since its approval for emergency use by Drug Controller General of India (DCGI) on June 1.
Most generic pharma companies hoping to produce and supply the drug in India are still awaiting approval from the Central Drugs Standard Control Organisation (CDSCO), which is learnt to be performing stringent checks on their manufacturing sites and testing their samples.
It is unclear though how many firms with voluntary licences from Gilead have received the drug regulator’s go-ahead to manufacture and supply remdesivir in India. Only Jubilant Life Sciences confirmed it received “conditional approval” for its generic version “subject to certain criterion being met”. It plans to launch its remdesivir in July 2020.
Zydus Cadila on Friday, and Dr Reddy’s Laboratories on Saturday, announced they were entering into non-exclusive licences with Gilead for remdesivir as well. These companies will now receive the know-how to make the drug and produce their own generics, after which they can approach CDSCO for approval to manufacture and market their versions in India.
Hetero Drugs and Cipla, which had already applied to CDSCO, declined to comment on the status of their approvals. Queries to Mylan, which also has a licence from Gilead, remained unanswered.
Meanwhile, patients are having to arrange the medicine on their own. In the last fortnight alone, at least three Covid-19 patients from Mumbai’s Dr LH Hiranandani Hospital have had to procure remdesivir using their own sources, according to CEO Dr Sujit Chatterjee. This is because there is no approved supply of the drug here at the moment.

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