Gildes Sciences’ generic version of Remdesivir – Covifor – obtains marketing authorization in India
New Delhi:
The Comptroller General of India (DGCI) has raised concerns about the black market and the profitability of Remdesivir, an antiviral medication prescribed for the treatment of suspected or serious laboratory-confirmed cases of COVID-19. The DGCI wrote to all the States and territories of the Union asking them to remain “strictly vigilant” and to prevent the sale of the drug above the MRP.
“Immediate application is needed to stop the sale of COVID-19 Remdesivir above MRP (maximum retail price),” the agency said, noting that unscrupulous people were engaging in black marketing and marketing. overvaluation of drug prices.
DGCI chief Dr. VG Somani said complaints had been received from a Uttar Pradesh-based community engagement and social media platform through the Ministry of Health.
On Monday, drug maker Mylan NV announced that it will launch a generic version of Remdesivir, originally developed by the American company Gilead Sciences Inc., in India.
The DGCI had authorized the generic version, labeled Desrem. Generic versions of two other manufacturers, Cipla Labs and Hetero Ltd, have also been removed.
Cipla valued its version, Cipremi, at less than 5,000 rupees per 100 mg vial, while Hetero valued its drug, Covifor, at 5,400 rupees.
Mylan’s Desrem was priced at Rs 4,800 ($ 64.3) per 100 mg vial, according to the Reuters news agency.
Approval of generic versions of Remdesivir, which is sought after helping to shorten recovery times for hospitals in a clinical trial, comes after Gilead Sciences did not import the drug after obtaining permission to do so. the DGCI.
In its letter of July 6, the CDSCO wrote: “Initially, the Remdesivir formulation of the innovator was approved on June 1, 2020 for importation and marketing … for the moment importing the drug after obtaining the Licence”.
Gilead, which has estimated Remdesivir at $ 2,340 per patient for the wealthiest countries, has agreed to send almost all of its supply to the United States within the next three months, according to Reuters, raising concerns about its availability elsewhere.
India has so far reported more than seven new cases of lakh coronavirus, with more than 20,000 virus-related deaths. The growth of new infections is worrying, with more than 20,000 cases reported every day since July 3.
Meanwhile, the race is on to develop a vaccine against the COVID-19 virus. India’s first vaccine candidate – COVAXIN from Bharat Biotech – is expected to start phase I clinical trials this month.
COVAXIN from Bharat Biotech is the first COVID-19 vaccine candidate made in India
The government has insisted it will release a viable vaccine by August 15, a statement criticized by experts who say rushed drug trials could pose serious health risks.
Two of the world‘s leading applicants – AZD1222 (British company AstraZeneca) and MRNA-1273 (based in the United States Moderna) – have been approved for phase II, III trials.
Typically, the first two phases of clinical trials test safety, while the third tests effectiveness.
On Sunday, the Ministry of Science and Technology issued a press release according to which, although 11 of 140 candidates for the coronavirus vaccine worldwide have been tested in humans, “none between them is only likely to be ready for mass use before 2021 “. This line has been edited in a revised version of the statement.
With the contribution of PTI, Reuters
