Moneycontrol learns from sources that the Drug Controller General of India (DCGI) will have to issue an import license to bring the Gilead’s Remdesivir stocks to India. The volume of this is still not known, but it will be in order of a few lakh vials.
The marketing authorisation for Gilead’s Remdesivir in India is with its local partner KlinEra Global Services(File image: Reuters)
India is likely to receive a few lakh unused vials of Remdesivir from US drug maker Gilead Sciences to ease shortage of the critical antiviral drug used for treating moderate to severe COVID-19 patients. Moneycontrol learns from sources that the Drug Controller General of India (DCGI) will have to issue an import license to bring the Gilead’s Remdesivir stocks to India from the US.
The volume of this is still not known, but it will be in order of a few lakh vials. Gilead’s decision to export Remdesivir to India is seen as a part of the Biden administration plan to support the Government of India and Indian health care workers as they battle the worst health crisis in the form of COVID-19.
India is reporting about 3.5 lakh new cases and over 2500 deaths on a daily basis. The Biden administration’s top medical adviser Dr. Anthony Fauci told ABC’s “This Week” that several measures were being considered to support India, including sending over oxygen supplies, COVID-19 tests, drug treatments and personal protective equipment. Gilead Sciences – the innovator of Remdesivir has given licenses to half a dozen Indian drug makers to manufacture and distribute the drug in India and more than 100 low-middle-income countries.
The marketing authorisation for Gilead’s Remdesivir in India is with its local partner KlinEra Global Services. India granted the conditional marketing authorisation for Remdesivir under the accelerated review process in June last year.
Gilead was granted a clinical trial waiver for Remdesivir so that the medicine can be made available to patients faster. India is facing acute shortage of Remdesivir and is scrambling to ramp up capacity. The production capacity is being ramped up from the current level of 38 lakh vials per month to 74 lakh vials per month. But, the ramp-up is taking time as Remdesivir is a complex injectable drug to produce.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
