The Indian government anticipated daily production of Remdesivir would reach 3 lakh vials within 15 days, according to reports from April 18, 2021. This increase followed a surge in COVID-19 cases and a corresponding demand for the antiviral drug.
Initially, domestic production capacity stood at 38 lakh vials per month. Efforts were undertaken to rapidly scale up manufacturing, with the goal of reaching nearly 119 lakh vials per month, according to a press release from the Press Information Bureau. The Department of Pharmaceuticals intensified monitoring of drug availability, production and supply in early April 2021 as cases began to rise sharply.
Seven Indian pharmaceutical companies – Cipla, Dr. Reddy’s Laboratories, Hetero, Jubilant Pharma, Mylan, Syngene, and Zydus Cadila – were licensed to manufacture Remdesivir in India under voluntary licenses granted by Gilead Life Sciences USA, the patent holder. All seven were directed to increase production quickly. The number of approved manufacturing sites was as well expanded from 22 to 60 through the approval of 38 additional sites.
To support domestic production, the government facilitated the procurement of necessary raw materials and equipment from foreign countries through the Ministry of External Affairs. Imports of Remdesivir were also pursued. Exports of the drug were prohibited beginning April 11, 2021, and customs duties were exempted on Remdesivir injection, the active pharmaceutical ingredient (API), and Beta Cyclodextrin (SBEBCD) used in its manufacture, effective April 20, 2021.
Recognizing the escalating demand, the central government began allocating Remdesivir to states and Union Territories starting in the third week of April, with an initial allocation of 11 lakh vials to 19 states and UTs experiencing high demand on April 21, 2021, for distribution through April 30.
An advisory issued by the government on July 6, 2021, focused on the rational use of Remdesivir, aiming to curb irrational use and over-prescription of the drug, which was authorized for emergency use. The Joint Monitoring Group, chaired by the Director General of Health Services, considered various studies before issuing this advisory.
