- DCGI's warning follows complaints of distributors selling the medicine above MRP to public
- Remdesivir is not meant for sale through medical shops, only direct supplies to hospitals
- Complaints say the drug costing Rs 5,400 per vial sold for Rs 15,000 to Rs 60,000 in black market
- So far only Hetero, Cipla and Mylan have approval for supplies
- Hetero has made over 20,000 vials and Cipla's first commercial batch came out today
The Drug Controller General of India (DCGI) has directed the department officials in states and union territories to keep strict vigil and prevent the black marketing of COVID-19 treatment drug Remdesivir, following complaints of the medicine being sold above the Maximum Retail Price (MRP) to the public.
In a letter to the official enforcement agencies yesterday, VG Somani, DCGI, said his office has received 'complaints regarding black marketing and over pricing by certain unscrupulous persons'. "Action taken in the matter may please be intimated to this office at the earliest," he said.
The DCGI said initially the Remdesivir formulation, an anti-viral injection innovator by the US-based Gilead Life Sciences, was approved by his office on May 1 for import and marketing it in the country. However, the innovator is yet to import, after taking license from the central drug standard control office (CDSCO). Later, permission was granted to manufacture and market the drug to Cipla, Hetero Drugs and Mylan, he said in his letter to the officials.
The Health Ministry on June 14 had included the drug as part of investigational therapy to manage COVID-19 patients who are admitted in ICUs with moderate to severe infection. Gilead gave voluntary licence to Indian drug makers Cipla, Dr Reddy's Laboratories, Hetero, Jubilant Lifesciences, Mylan, Biocon subsidiary Syngene, and Zydus Cadila to manufacture remdesivir for distribution in 127 countries. Except Cipla, Hetero and Mylan, the others are yet to get the approval.
Sachin Taparia, Chairman and CEO of LocalCircles, a social media platform for social causes, had written a letter yesterday in this regard to the DCGI, NPPA, Health Ministry and many state and central officials requesting to put an end to the black marketing of this critical drug. In his letter, Taparia said the MRP of remdesivir marketed by Hetero is Rs 5,400 (per 100 mg vial), but consumers have reported it being sold at prices anywhere between Rs 15,000 to Rs 60,000.
"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," he said.
Informed sources said after the approval, Hetero has supplied about 20,000 vials to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other regions in Maharashtra, and to other parts of the country. They said these drugs are not supposed to be sold through the medical stores to the public, as the approval is for 'Emergency Use'. The supplies have to be done directly to the hospitals. What happens is when hospitals find the drug is in short supply, they direct relatives of the patients to the distributors, who call the shots. Many state governments have given upfront payments to get the drugs and are waiting for the supplies. On emergency, some of the companies were already supplying the trial batches free to certain State Governments in the past few weeks, they said.
Meanwhile, Daman-based Sovereign Pharma, the contract manufacturer for Cipla, said it has today dispatched its first batch of remdesivir injections for Cipla. "We have been constantly manufacturing remdesivir since last month, and at our current capacity, we can supply 50,000 to 95,000 pieces of the injectable per month," said Rishad Dadachanji, director, Sovereign Pharma.
Cipla had signed a contract manufacturing agreement with BDR Pharmaceuticals, which had made its own generic version of active ingredient of remdesivir. BDR then further transferred the formulation technology for manufacturing and packaging of the generic drug to Sovereign, a Contract Manufacturing Organisation (CMO) specilised in making injectables for various drug companies, about 350 million pieces each year.