Supply Crisis Around Remdesivir Sees Cos Scrambling To Boost Supplies

Mumbai, 12 April 2021:

PT Jyothi Datta As Gilead Sciences’ anti-viral drug remdesivir runs in short supply in India, local drug companies that have a license to make the injectable are working on boosting supplies to address, what one industry representative called a “frightening” situation.

In fact, the Central Drugs Standard Control Organisation (CDSCO) has even written to the States and Union Territories asking the authorities to act against malpractices and hoarding of the drug, as reports emerge of it being sold at 10 times its retail cost. Some domestic industry representatives are even urging Government to intervene and allow more companies to make this patent-protected drug, in the interest of public health.

American company Gilead had given voluntary licenses on remdesivir to Cipla, Dr Reddy’s Laboratories Ltd, Hetero Labs, Jubilant Lifesciences, Mylan (sourcing from India), Syngene (a Biocon company) and Zydus Cadila. An agreement allowed them to produce the drug for local use and export to 127 low and middle income countries. The local price for most companies hovered at about ₹4,000-odd, for 100 mg, though Zydus recently dropped the price to ₹899.

Cos taken by surprise

Pharma-industry insiders told Business Line that last year companies had ramped-up manufacturing following reports of shortages and strategies were revised to have a buffer stock to make it available at short notice. Inaccurate forecasting on the requirement, based on inadequate testing, was the culprit then, they said.

This time, as cases were seen to drop some months ago, companies too took their foot off the accelerator, a drug regulatory official said. Since the product has a short shelf-life and a complex manufacturing process, it was not easy to increase supplies as quickly as the cases began to surge, he pointed out.

“. All companies are trying in multiple ways to enhance the supply by boosting capacity at existing sites and qualifying additional sites,”a Cipla spokesperson said, adding that they upped capacity by “2x”.

“Not life-saving”

States like Gujarat, Maharashtra and Madhya Pradesh, for instance, have witnessed patient families trying to access the drug, which should in fact be procured by the treating hospital.

The crisis around remdesivir plays out, even as a World Health Organization-panel said last year that that there was no evidence the drug “improved survival or the need for ventilation”.

Dr Shashank Joshi, member with the Maharashtra Covid taskforce explained, the drug was not “life-saving”. However, it is useful when given in the first nine days, when the virus is replicating, and it reduced hospital stay between one and three days, he said.The Hindu Businessline