India's drugs regulator has asked drug controllers in states and Union Territories to keep a strict vigil to prevent black marketing of the anti-viral Remdesivir injection, approved for emergency and restricted use to treat COVID-19 patients.
Drugs Controller General of India (DCGI) Dr V G Somani said in a communication to Drugs Controllers in states and UTs that his office received a letter raising concerns that certain unscrupulous persons were indulging in black marketing and over-pricing of the drug.
He said the complaint was received from LocalCircles, a community engagement and social media platform, through the ministry of health.
The Central Drugs Standard Control Organisation (CDSCO) has approved restricted emergency use of Remdesivir injectable formulation for treatment of patients with severe COVID-19 infection subject to various conditions and restrictions, Somani said in his letter on Monday.
Initially, Remdesivir formulation of the innovator was approved on June 1 for import and marketing in the country. However, the importer is yet to bring it to India after taking import license from the CDSCO.
Subsequently, the CDSCO has granted permission to manufacture and market the drug to Cipla, Hetero, and Mylan laboratory for same indication, conditions and restrictions, the letter stated.
"In view of the above, you are requested to instruct your enforcement officials to keep strict vigil on the matter to prevent the black marketing and sale of the drug Remdesivir injection above MRP.
"Action taken in the matter may please be intimated to this office at the earliest," Somani said in his letter addressed to state and UT drug controllers.
The Union Health Ministry in its Clinical Management Protocols for COVID-19' has allowed the use of Remdesivir for restricted emergency purposes in patients in the moderate stages of the COVID-19 disease under "investigational therapies".
The LocalCircles in its letter said that it received many posts and comments from citizens across India on its platform about the alleged black marketing of Remdesivir.
"The MRP of Remdesivir marketed by Hetero Healthcare Limited is Rs 5,400 but consumers have reported it being sold at a price of anywhere between Rs 15,000 to 60,000," the LocalCircles said.
"Various medical shops have been telling buyers that the medicine is in short supply but can be made available if they are ready to pay a premium. This is putting an extreme pressure on the families of many critical patients who are trying hard to somehow secure the medicine.
"It has also been reported that doctors at many private hospitals are directing families to procure and get the medicine themselves," it said. In a survey conducted by LocalCircles, which received 8,329 responses, 93 per cent consumers from 233 districts of India said the legal metrology and drug inspectors should be directed to immediately act against such black marketing of the Remdesivir, which at this point in time, could be termed as a life-saving drug, the letter mentioned.