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

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.

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.

“In this situation, the patients are responsible for bringing the medicine and we administer it after taking a certificate that this is on compassionate grounds. We’re not happy with this situation…any drug that you buy must have an MRP printed on it and, if that is not there, then it is a grey market drug,” Dr Chatterjee said.

Nearly two weeks ago, DCGI Dr VG Somani, who heads CDSCO, allowed Mumbai-based Klinera Global Services to import remdesivir from three manufacturing sites in the US, including Gilead’s own manufacturing plant.

Remdesivir’s emergency authorisation in India means it is allowed as part of treatment despite clinical trials still ongoing to test its effectiveness, but its use is to be heavily restricted and monitored.

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The guidelines released Saturday follow CDSCO’s decision to limit remdesivir’s use to only five days, allowing a dose of 200 mg on the first day followed by 100 mg dosage for the remaining days. It also doesn’t allow its use in pregnant patients, children under 12 years and patients with severe kidney impairments.

Yet, it is unclear whether any vials of the drug have been imported since CDSCO’s approval to Klinera, and queries sent Friday morning to the firm as well as Gilead about the status of imports remained unanswered by Saturday.

But what is certain is several hospitals seeking remdesivir have not been able to get it from approved suppliers.

“Even after receiving its approval for emergency use, not a single vial of remdesivir seems to have been imported from Gilead. Where is the drug?” said Leena Menghaney, the South Asia head for Medecins Sans Frontieres’ Access Campaign.

In the absence of imports, at least two firms awaiting CDSCO approvals have been supplying their generic remdesivir to select patients for free “on humanitarian grounds”, an industry executive directly aware of the development said on condition of anonymity. However, this has not been officially confirmed by any of the companies.

Activists and experts demand greater transparency in CDSCO’s approval process and in making the drug available, failing which there are concerns it could drive this business underground.

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“My biggest fear in this process is, when you don’t know what the government is going to do and people are pushed to the brink, the uncertainty will drive them to do desperate things. Someone will take advantage of it, and we might see remdesivir being sold like hooch,” said Murali Neelakantan, former global general counsel of Cipla and Glenmark Pharmaceuticals.

While emailed queries and phone calls to DCGI’s Dr Somani remained unanswered till Saturday, a senior government official had earlier told The Indian Express the approvals were under process. CDSCO needed to ensure the generic versions of remdesivir adhered to quality and safety standards for this medicine.

As on Friday, the regulator had finished inspection of BDR Pharmaceuticals International’s active pharmaceutical ingredient facility “on account of Cipla”, said CMD Dharmesh Shah. BDR had tied up with Cipla following controversy over its move to manufacture its own generic of remdesivir, which Gilead has patented in India.

“They have asked for samples of our product, which will be tested at their Central Drug Testing Laboratory. We will be submitting those samples (on Saturday),” Shah told The Indian Express. “While we await approvals, we have received calls from a huge number of patients trying to access the drug. We can’t do anything,” he said.

There is a dilemma over whether approvals should be fast-tracked further, even skipping certain procedures, to ensure that patients get early access to the product.

However, some feel this might risk patient safety. “The real test of any of these procedures is during a crisis. If you say that, during a crisis, you will not follow the procedure, it undermines the authority of the regulator,” said Neelakantan.

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