New Delhi: The central government has stepped up pressure on makers of remdesivir, one of the most sought-after experimental drugs for the treatment of Covid-19 patients, to ensure increased output, ThePrint has learnt.
The Department of Pharmaceuticals (DoP) held two meetings with the manufactures of the drug in the last 20 days to check the status of production, manufacturing capacity and challenges, if any. The department is planning another meeting soon.
Drug makers, on their part, have pointed to the long manufacturing process to indicate their hesitation in investing heavily since a vaccine, if released earlier than expected, could lead to big losses for them.
The meetings, held on 3 July and 10 July, were attended by V.G. Somani, Drug Controller General of India (DCGI), Shubhra Singh, chairman of National Pharmaceuticals Pricing Authority, and P.D. Vaghela, DoP secretary along with the joint secretaries.
Representatives of drug makers Cipla, Jubilant Life Sciences, Mylan, Hetero, Zydus Cadila and Dr. Reddy’s were also present.
“We have taken two meetings with the industry and are planning to hold another meeting soon. Two companies are yet to get DCGI’s nod, namely Dr Reddy’s and Zydus Cadila. All other companies have ramped up the production between the first and second meeting,” said an official from DoP.
“The main objective of the meeting was to instruct the industry to keep increasing the product as the reports of market-shortage and black marketing were coming in. Now, the issue of black marketing is almost sorted as, except two, all companies have started sending supplies into the market.”
The official further said, “The industry has explained that the manufacturing of this drug is not an easy process and involves 21 processes and 14 raw materials. They are also afraid of (making too many) huge investments as they may go to waste if a vaccine arrives.”
Investments intensive, long manufacturing process
While the government asked pharma companies to increase their production, the companies asked DoP to share the forecast on the number of new infections expected so they may produce based on requirement.
“The industry fears that their investments might go waste if the vaccine came in early, especially the indigenous Covaxin, which is being pushed for launch on 15 August,” said another government official who was present at the meeting.
Human clinical trials for Covaxin, being developed by Bharat Biotech and the Indian Council of Medical Research (ICMR), will be beginning soon.
Apart from being cost-intensive, manufacturing the drug involves a long process, which is what took time to meet market demands after the initial DCGI approvals.
“We explained that the drug, which is injectable, needs a 14-day period for the process, called sterility. It also requires a minimum four-day period for a process called lyophilization,” said a representative for one of the biggest pharmaceutical companies in India at the meeting.
To ensure the safety of patients, the drugs are sterilised to destroy the possible microorganisms whereas lyophilization is done to bring down the drug’s storage temperature to room temperature level.