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New Delhi : Department of Pharmaceuticals, GoI, intensified monitoring of availability, production, and supply of drugs used for Covid-19 treatment in early April, 2021, as number of cases of Covid-19 started increasing steeply. Remdesivir is a patented drug manufactured in India under voluntary licenses granted by Gilead Life Sciences USA, the patent holder, to 7 Indian pharmaceutical companies (Cipla, Dr Reddy’s Lab., Hetero, Jubilant Pharma, Mylan, Syngene,and Zydus Cadila).

To augment the domestic production capacity, all the seven domestic licensed manufacturers of Remdesivir were asked to ramp up production quickly. With combined efforts of the central government and the manufacturing companies, the production capacity of the licensed manufacturers has increased unprecedentedly from 38 lakh vials per month to nearly 119 lakh vials per month.

With accelerated approval for 38 additional manufacturing sites, the number of  approved manufacturing sites of Remdesivir in country has increased from 22 sites to  60 sites. With the help of Ministry of External Affairs, the manufacturers of Remdesivir are being facilitated for getting supplies of requisite raw materials and equipment from foreign countries, according go a PIB release.

All efforts are being made to enhance the availability of the drug both through imports as well as augmented domestic production.  Exports of Remdesiver has been prohibited since April 11, 2021. Customs duty has been exempted on Remdesivir injection, Remdesivir API, and Beta Cyclodextrin (SBEBCD) used in the manufacture of Remdesivir with effect from April 20, 2021.

Looking at the suddenly increased demand in the country, in order to ensure equitable distribution of Remdesivir among different regions of the country, the central government has been making allocations to States and UTs since third week of April.  Interim allocation of 11 lakh vials was made for 19 states and UTs with high demand on April 21, 2021, for period up to April 30. This allocation was increased to 16 lakh vials on April 24 as more supplies became available and all States and UTs were allocated the vials. In a series of allocations issued subsequently, with latest allocation issued on May 16, 2021, a total of  76 lakh vials in total have been allocated among States for period up to May 23, 2021.

The State Governments and UTs have been asked to monitor proper distribution within their jurisdiction covering both government as well as private hospitals and in line with judicious use as advised in the “National Clinical Guidance for management of adult Covid-19 patients” issued jointly by AIIMS/ICMR Covid-19 National Task Force and Joint Monitoring Group of MoHFW.

State Governments / UTs have been advised to place adequate purchase orders with the marketing companies immediately for the quantity that they want to purchase out of allocation for the State/ UT as per supply plan in close coordination with liaison officers of the companies. The coordination with private distribution channel in the state is also to be made by the States.

All the seven Indian manufacturers have been making supplies to States as per the allocation both against government purchase orders and also through their private distribution channels in States. Total 54.15 lakh vials of Remdesivir have been supplied across the country by the Drug companies during April 21- May 15, 2021, period. Supply of Remdesivir to Various State Governments and central Institutions is continuously being monitored and whenever any complaint regarding supply is received, it is taken up immediately with the manufacturer concerned. Department of Pharmaceuticals, through National Pharmaceuticals Pricing Authority (NPPA), is in constant touch with all the States through their Nodal officers and manufacturing companies through their Liaison Offficers.

In addition to allocation mentioned above, as on May 16, 2021, a total of 5.26 lakh vials of Remdesivir, which have been received through donation from other countries/organisations and 40,000 vials which have been commercially imported, have also been allocated to States and UTs.