Remdesivir pricing in India likely to be lower than global rate: Sources

Indian companies await clarity from the drug regulator on animal toxicology study before they can launch here

US major Gilead's remdesivir, which has shown potential to reduce the viral load in Covid-19 patients, is likely to be priced lower than the global rate in India, according to multiple sources close to the development. The Indian pricing regulator is keeping a close watch on the situation, and would review the prices once companies launch the product in Indian market. 

Meanwhile, several traders have quoted prices (for example Rs 15,000 for 100 mg/20 ml vials) for remdesivir on online business-to-business shopping sites even before the drug is available in the market. Indian companies clarify that this is far from the truth and that these suppliers have no stock lying with them. The global price range doing the rounds is of $4,000-5,000 for a course of the drug. This works out to be roughly Rs 350,000 in India. 

A senior government official said the price in India would not be that high. "Companies have the liberty to price the drug. We have no plans to invoke para 19 of the Drug Price Control Order (DPCO) now. Once the drug is launched, we will review the price and will take necessary action. The price in India would not be as much as the drug would cost in US," he said on grounds of anonymity. 

Meanwhile, one industry source even pointed out that since the drug is administered in hospitals (as an injectable) and the US healthcare system works on an insurance model, the price could even be higher than $4,000 for the course. Gilead did not answer an email sent. 

Several Indian players said the pricing of the drug would not be 'unreasonable' as they were aware of their social responsibility. "This drug will not form the bulk of the hospitalisation cost for a patient. At present, some patients are paying as much as Rs 30,000-35,000 per day if they are on ventilator in intensive care units and have to stay for a fortnight if the condition does not improve," said a source. 

So far, only Gilead has the approval to launch in India from the Drug Controller General of India (DCGI). Around three Indian and one multinational firm with India manufacturing presence have license from Gilead to make and distribute the drug. However, none of these firms yet have the DCGI nod to launch. These include Cipla, Hetero, Jubilant Life and Mylan. 

Industry sources indicate that for launching a completely new drug, animal toxicology data is required. "It is not clear whether this requirement will be waived for remdesivir as there is an emergency need for the drug in the market," said an industry souce. Gilead got the approval as it presented global data to the Indian regulator. Moreover, after the DCGI grants a product license, then the companies need to get the manufacturing license (which is product specific) from respective state FDAs where they plan to manufacture. 

"We are ready with everything. However, one cannot commence commercial manufacturing unless one has the license from the drug regulator," said one company source. As of now the plan is to have the active pharmaceutical ingredient (API)  for the product made in India. However, companies admit that some key starting martial (KSM) will be required from China. 

One supplier on a B2B website that Business Standard spoke to said that they were importing the API from China and supplying to formulators. "But this is not high quantity. We are supplying 100-200 grams of the API for research and development purposes," he clarified. For a patented product like remdesivir, commercial manufacturing of the API is not allowed.