Reduction in production due to less demand after the first wave of coronavirus and lack of vigil on the part of the Government to ensure stockpiling led to current Remdesivir crisis, say sources.
Gilead Life Sciences, the innovator of the re-purposed drug, had licensed six manufacturers in India to produce the drug. Most of them were dependent on contract manufacturers and their subsidiaries to make the product. Demand fell to almost nil by January after the first wave of the pandemic in the country. Since there was no demand, most manufacturers stopped giving fresh orders for manufacturing. Neither the manufacturers nor the policy makers anticipated a second wave and failed to stockpile the life saving drug, sources said.
While the active pharmaceutical ingredient (API) and main raw materials for the drug can be domestically sourced, only a few intermediates have to come from countries like China or Egypt. However, its availability was not an issue. If raw materials are available, the drug can be produced within 1-2 weeks. But, black marketing, supply chain issues and spike in Covid-19 cases in Delhi, Maharashtra, Karnataka led to a shortage, sources said.
Remdesivir was produced in full capacity in March-April with 25-30 lakh vials getting produced a month. As of April, India was making 38.8 lakh vials of Remedesivir per month, as government allowed the producers to increase capacity. Of them, Hetero Drugs was the largest manufacturer with 33 per cent capacity (13 lakh vials a month). Cipla accounted for 20 per cent, or 7.6 lakh vials, Zydus Cadila 16 per cent or 6.1 lakh vials. Mylan Labs was making 5 lakh vials accounting for 13 per cent of total capacity. Dr Reddy's Labs, Syngene and Jubilant Ingrevia, each accounted for 6 per cent producing 2.4 lakh vials a month. With the cases rising, the government has approved 25 remdesivir manufacturing sites last week. This will increase the production to over 90 lakh vials a month, they said.
"Now about ten new manufacturing sites have come up and production has increased by 20 per cent," said Daara B Patel, Secretary General of Indian Drug Manufacturers Association. "We have scaled up the production of Remdesivir by 2x from the last wave of the pandemic. Given the unprecedented demand for the drug, we have now further ramped up our capacities through our network, to service the demand," said Cipla.
According to an affidavit filed by the Government in the Supreme Court on April 21, current production of Remdesivir is about 74 lakh vials per month and once the additional manufacturing sites go on stream by May, the production will increase to over 90 lakh vials per month.
A health ministry statement said the production capacity of the seven licensed domestic manufacturers have increased from 38 lakh vials per month to 1.03 crore vials per month and a total 13.73 lakh vials have been supplied across the country between 21-28 April. The daily supply has gone up from 67,900 vials on 11th April to 2.09 lakh vials on 28th April. HLL Lifecare, a Government of India owned company in charge of government procurement, has also ordered 4,50,000 vials of Remdesivir from Gilead Sciences USA and Egyptian Pharma company, Eva Pharma. The first consignment of 75,000 vials had reached a couple of days ago.
Further, the Department of Revenue on April 20 exempted the customs duty on Remdesivir injection, its API and Beta cyclodextrin used in manufacture of Remdesivir, till 31 October. On April 17, the National Pharmaceutical Pricing Authority put a cap on its prices to Rs 3,500.
Meanwhile, the Supreme Court on April 30 asked whether the Centre has considered invoking section 92 of the Patents Act to increase availability of COVID-19 medicines. A petition filed by Jan Swastya Abhyan seeks the Supreme Court to issue authorisation for using the patents for government purpose under Section 100 of the Patents Act. "Provisions in the Patent Act allows to invoke compulsory licensing as this is a pandemic and a national emergency," said Gopakumar G Nair, founder and CEO of GNA Patent Gurukul, a patent specialist firm.