The health ministry may have reduced the dosage of “investigational therapy” Remdesivir over concerns related to liver toxicity, but Indian companies are pressing on with manufacturing the drug.
By the end of this month, India could be producing over 20,000 vials of Remdesivir per day, according to figures compiled by the Central Drugs and Standards Control Organisation (CDSCO).
Originally developed by American drug-maker Gilead, Remdesivir is touted as the best therapeutic hope against Covid.
In India, the drug is now being manufactured by Cipla, Hetero Labs and Mylan.
“M/s Hetero plans to supply 10,000 vials per day and 60,000 vials per week of Remdesivir Injection. M/s Cipla plans to launch the drug on 8th July and in July, they will manufacture 5 to 6 batches i.e 5,000 to 6,000 vials with an average capacity of 10,000 vials every 4th day,” according to a note prepared by the Drug Controller General of India (DCGI) V.G. Somani, who heads the CDSCO.
“M/s Mylan plans to launch their product between 22-24th July 2020 with a capacity of 2,70,000 vials per month, which can be increased to 4,00,000 vials depending on demand/order position,” it said.
The note also details the actions taken by the drug controller with regard to reports of black-marketing of Remdesivir.
When ThePrint reached the Hetero spokesperson, he said clarity about the capacity and supply chains of the drug would only emerge in the coming weeks, and the company would like to make a public statement only after that.
ThePrint also reached Mylan via email and calls, but there was no response until the time of publishing this report.
Meanwhile, Cipla Wednesday launched Remdesivir under the brand name Cipremi, and announced it will only be available in hospitals.
Nikhil Chopra, Executive Vice-President and CEO India Business, Cipla, told ThePrint: “We are proud to commercially launch CIPREMI today; amongst the lowest priced globally, and aim to supply over 80,000 vials within the first month itself. To further ensure equitable distribution, CIPREMI will be available via government and hospital channels only. Cipla will also be donating some amount of the drug as part of its efforts to support the community in this time of need.”
Remdesivir is approved in India for use in Covid patients as an investigational therapy in moderate cases, provided there is no history of liver or kidney disease. The drug is not recommended for use in pregnant and lactating mothers, and in children.
Last week, the ministry of health limited the use of the drug to a total of five days after receiving reports from government and private hospitals about patients, who were given the drug, showing a sudden rise in levels of enzymes that indicate liver injury.
According to the earlier clinical management guidelines, the drug could be administered for a maximum of 6 days.
The drug has also received emergency use authorisation from the US drug regulator, the Food and Drug Administration, to treat Covid-19.
Mixed trial results
Initial trial results of the drug have been mixed.
A trial in May funded by the National Institute of Allergy and Infectious Diseases in the United States found Remdesivir could speed up recovery in Covid patients, requiring oxygen therapy.
But in an earlier study published in The Lancet, Chinese researchers reported they could not find any “statistically significant clinical benefits”.
However, powered by these trial reports and the general buzz about the drug, there is already a very high demand for the drug in the Indian market.
That is why there are reports of the drug being sold at a premium in black market.
Upload information on websites
The CDSCO has told all the three companies to upload on their websites all the details about supply chains, distribution and the quantities of the drug that will be made available in the coming weeks.
Hetero has already created a portal where the information about availability of the drug is uploaded. The user has to submit his/her mobile number and the state where s/he belongs to get the information.
About black-marketing of the drug, ThePrint has reported that the drug controller on 6 July wrote to states and union territories, asking them to take steps to prevent black-marketing of the drug.
“… you are requested to instruct your enforcement officials to keep strict vigil on the matter to prevent the black-marketing and sale of the drug Remdesivir Injection above its MRP,” stated a letter written by DCGI Somani to states/UTs. – The Print