New Delhi: With the rapid increase in the number of Covid-19 cases, the Department of Medicines in early April 2021 intensified the monitoring of the availability, production and supply of medicines used for Covid-19 treatment. Remdesivir is a patented drug made in India under a voluntary license granted by patent holder Gilead Life Sciences America to seven Indian pharmaceutical companies (Cipla, Dr. Reddy’s Lab, Hetero, Jubilant Pharma, Mylan, Syngene and Zydus Cadila).
To increase domestic production capacity, all the seven domestic licensed manufacturers of Remdesivir were asked to accelerate production. With the joint efforts of the central government and construction companies, the production capacity of licensed manufacturers has increased unprecedentedly from 38 lakh vials per month to about 119 lakh vials per month. With the approval of 38 additional manufacturing sites rapidly, the number of approved manufacturing sites of Remdesivir has increased from 22 to 60 in the country. With the help of the Ministry of External Affairs, the manufacturers of Remdesivir are being provided the facility to obtain the supply of the necessary raw materials and equipment from abroad.
All efforts are being made to increase the availability of the drug through imports as well as enhanced domestic production. The export of Remdesivir has been banned from April 11, 2021. The customs duty on beta cyclodextrin (SBEBCD) used in the manufacture of Remdesivir injection, Remdesivir API and Remdesivir has been exempted from April 20, 2021.
In order to ensure equal distribution of Remdesivir in different regions of the country, the Central Government has been allocating it to the States and Union Territories from the third week of April, in view of the sudden increased demand in the country. On 21 April 2021, an interim allocation of 11 lakh vials was made for 19 states and union territories with high demand for the period up to 30 April. On 24 April, this allocation was increased to 16 lakh vials as more supplies became available and all states and union territories were allotted vials. A total of 76 lakh vials have been allocated among the states for the period up to May 23, 2021, in a series of allocations issued later, with the latest allocation released on 16 May.
State Governments and Union Territories have been asked to monitor proper distribution in their jurisdiction, both government and private hospitals will come under the purview of the AIIMS / Indian Council of Medical Research Covid-19 National Task Force and Health and Family Welfare This is consistent with prudential use as advised in the joint “National Clinical Guidance for the Management of Adult Covid-19 Patients” issued by the Joint Monitoring Group of the Ministry.
The State Governments / Union Territories have been advised to buy marketing companies immediately enough for the quantity they want to purchase from the allocation for the State / UT as per the supply scheme in close coordination with the liaison officers of the companies. Order of State governments also have to coordinate with private distribution channels in the state. State governments have also been advised to set up a mechanism to issue this medicine to needy patients and publicize it well among the public in the state.
All seven Indian manufacturers are supplying to states as per government procurement orders and allocation through their private distribution channels in the states. During the period from April 21 to May 15, 2021, a total of 54.15 lakh vials of Remdesivir have been supplied by the pharmaceutical companies across the country.
The supply of Remdesivir to various state governments and central institutions is constantly being monitored and whenever a complaint regarding the supply is received, it is immediately taken up with the manufacturer concerned. The Department of Pharmaceuticals, through the National Drug Pricing Authority (NPPA), is in constant touch with all the states through its nodal officers and with all the manufacturing companies through its liaison officers.
Apart from the above mentioned allocations, as of May 16, 2021, a total of 5.26 lakh vials of Remdesivir, which have been received through donations from other countries / organizations and 40,000 vials which have been commercially imported, are also exported to the States and Union Territories. Has been allocated to.