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.