April 19, 2021 2:10:27 am
Maharashtra is hopeful of resolving the Remdesivir shortage from April 21. On Saturday, Kamla Lifesciences, a manufacturing unit for Cipla, received licence to produce liquid Remdesivir in its Palghar plant; and two exporters— BDR Lifesciences and Bruck Pharma Pvt Ltd — have got emergency approval to distribute Remdesivir locally in Maharashtra to licensed stockists and Covid hospitals.
FDA has pushed Cipla to manufacture liquid Remdesivir as early as possible after all permissions were cleared on April 17. Officials in Kamla Lifesciences told The Indian Express that they will begin manufacturing 90,000-95,000 liquid Remdesivir vials per day from April 19.
“FDA has approved rapid sterility test which will require another 3-4 days once the bulk stock is produced,” an official from Kamla Lifesciences said. FDA expects Cipla to supply 50,000 vials of liquid Remdesivir every day to Maharashtra after April 21-22.
“Currently manufacturers have informed us they have exhausted most of their stock. There is limited stock in the market, yesterday we received only 33,000 vials,” an FDA official said.
Maharashtra’s daily demand for Remdesivir is above 50,000 vials per day, which the state is unable to meet. Haffkine Biopharma, the nodal agency for procurement, floated two tenders of 6 lakh and 2 lakh vials and received no bidder.
Manufacturers said liquid Remdesivir is faster to produce than lyophilised formulation and the latest approval to Kamla Lifesciences may bring stability in the state’s supply.
Maharashtra FDA said it has already reached out to all 16 manufacturers to share details of their stockpile and whether they would be willing to supply to Maharashtra.
Of them, Bruck and BDR have been given local authorisation for distribution only in Maharashtra, although the two do not yet have marketing approval from Gilead. Gilead’s marketing approval for Remdesivir in India is for Cadila Healthcare, Cipla, Dr Reddy’s, Syngene International, Mylan, Jubilant and Hetero Healthcare.
Apart from them, 16 exporters have permission to only export and not market in India. “Government is very cautious. If we give marketing authorisation to these exporters, Gilead can take an objection. In current scenario, we are giving emergency approval to few exporters to supply their remaining stock to us in view of a disaster situation,” an FDA official said.
The official added, “Under emergency, state or central government has powers to give permission to an exporter to supply stock for local consumption for limited time. The Medical Education and Drugs Department approved BDR and Bruck. Maharashtra is awaiting response from other exporters on whether they can supply in local market.” Recently Gujarat FDA also approved BDR Lifesciences to supply 1.14 lakh Remdesivir vials.
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