MUMBAI: Maharashtra’s decision to procure 10,000 vials of remdesivir from an apparently unlicensed Bangladeshi manufacturer of Gilead Sciences’ Covid-19 drug has surprised Indian companies, which await the central drug regulator’s nod to sell this medicine in the country. Indian firms said that the Bangladeshi company with which Mantralaya is in talks has neither the import licence, nor a manufacturing licence from Gilead to sell the drug in India. The procurement price of the drug, seemingly at more than double the rates of Dhaka, is also raising questions.
"Gilead has not provided a licence to Eskayef Pharmaceuticals or any other company in Bangladesh to manufacture remdesivir,” Gilead said in a statement to ET. “Gilead cannot comment on or verify the authenticity or effectiveness of this product as it is not manufactured by Gilead or one of our licensed partners On June 6, Rajesh Tope, health minister of Maharashtra, said the state would buy remdesivir from Eskayef Pharma, a company based out of Dhaka, at $160 per vial, or ₹12,000 per vial, for 10,000 doses. The price of this drug in Bangladesh retail market is around $60-65, according to some Bangladesh pharma companies ET spoke to. In India, domestic distributors are quoting a price of ₹7,000 per vial for a licensed Gilead drug even before its formal launch.On his Twitter account, Tope said that since Indian companies are waiting for a nod from the regulator, the state would approach the Bangladeshi company for supplies. The state government is looking to purchase the drug from the CM relief fund corpus.
Even if Maharashtra wants to bring Bangladesh-made remdesivir into India, it has to hurdle regulatory barriers before procuring it. Besides obtaining an import licence from the central drug regulator, it has to convince commerce ministry to evoke special provisions of patent act to get a non-licensee to bring drug into the country.
There is a draft guideline on import of drugs for compassionate use. States scan through the medical institutions can import a drug if certain criteria are met.
“An existing patent for the drug in India is not a hurdle to import since central government can issue an order under section 92(3) of the Indian Patent act to import a drug during an emergency or under section 100 for non-commercial use. However, even after this is issued, there will be a need for an import licence under the Drugs and Cosmetics Act from the CDSCO,” said Murali Neelakantan, a lawyer specializing in drug regulation and IP law. “The drug controller would have to take a decision based on scientific and production data by the Bangladeshi company and issue a licence.”
BDR Pharma said local firms are ready to step in. “When Indian companies are ready...to make this product available, why should the government import from Bangladesh?” asked Dharmesh Shah, MD of BDR Pharma. However, BDR is not one of the authorised licencees of remdesivir.