New Delhi: The Delhi High Court issued notice to Centre and various other pharmaceutical firms to reply to public interest litigation, that seeks to allow drug companies making anti-viral Remdesivir, to sell their stocks in the country. On Monday, the Delhi HC took the plea, filed Amit Saxena, Joint Secretary, Delhi High Court Bar Association regarding immediate grant of licence or permissions to the companies and exporters manufacturing life saving drug Remdesivir to sell their export material drug (lying in warehouses and ports) in the Indian domestic market.
Remdesivir is approved in India for restricted emergency use for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
The plea seeks a grant of permission for exporters to manufacture and sell the drugs in India, which are meant for export to other countries. The Delhi High Court bench of Chief Justice D N Patel and Justice Jasmeet Singh have issued a notice to the Ministry of Health and Family Welfare, Central Drugs Standard Control Organisation, Director General of Foreign Trade, and pharma companies, like Cadila, Cipla and Zydus to state their stand on the plea.
The petitioner Dincur Bajaj, a lawyer and member of the Delhi High Court Bar Association, claims that as many as 25 companies in India are involved in manufacturing the anti-viral drug, however, only six to eight are permitted to sell the drug in India while all the others have been producing it for exports to other countries.
There are seven Indian companies that are producing Remdesivir under a voluntary licensing agreement with Gilead Sciences, USA. They have an installed capacity of about 38.80 lakh units per month. The American pharmaceutical company Gilead announced its plan to expand the availability of anti-viral drug Remedisivir, in India on April 30. In addition to providing support to its licensees to expand their local manufacturing capacity, Gilead also plans to donate at least 450,000 vials of Remdesivir to help address the immediate needs of Indian patients.
The Gilead agreements allow the companies – Cipla Ltd.; Dr. Reddy’s Laboratories Ltd.; Eva Pharma; Ferozsons Laboratories; Hetero Labs Ltd.; Jubilant Lifesciences; Mylan; Syngene, a Biocon company; and Zydus Cadila Healthcare Ltd. – to manufacture Remdesivir for distribution in 127 countries including India.
However, limited stock for drug sale in India has resulted in extensive black marketing of Remdesivir. The price of Remedisivir which falls between Rs 2800 (Zydus) to Rs 6000 (Hetero) has shot up to Rs 1,00,000 per vial in the black market due to non-availability of the drugs.