According to DCGI suggestion, companies must put in place a 24×7 helpline where the patients or their family members could contact in case the drug is not available in the market or is being overcharged
India’s drugs regulator DCGI has asked manufacturers to set up a helpline for patients and also put on their websites details of distributors and supply chain, to prevent black-marketing and overpricing of COVID-19 drugs such as remdesivir.
Rajesh Bhushan, the Officer on Special Duty, Union Health Ministry, told an online media briefing that it has been noticed that certain drugs are not available freely in the market.
Therefore, the Drugs Controller General of India (DCGI) has written letters to companies manufacturing them with two specific suggestions, he said.
“First suggestion was that these companies must put in place a 24×7 helpline where the patients or their family members could contact in case the drug is not available in the market or is being overcharged.
“Second suggestion given was that they must proactively put on their website the details of their distributors and their supply lines so that all confusion and anxiety in the market subside,” he elaborated.
He further said, the DCGI has also directed state governments to instruct drug inspectors to ensure that there is no black marketing of drugs which is being used in the treatment of COVID-19 patients.
In the letters Bhushan mentioned, DCGI Dr VG Somani has told these firms, “You are…requested to upload the information on your websites regarding the distributors and supply chain details along with quantities where remdesivir has been made available, to prevent black marketing and overcharging of the drug.”
Somani has also asked them to inform his office the action taken in the matter.
Considering the “emergency and unmet medical need” for COVID-19 disease, Somani said, the CDSCO has granted permission to companies to manufacture and market remdesivir injectable formulation for restricted emergency use for the treatment of patients with severe infection.
“This office has received representation raising concerns regarding black-marketing and overcharging of the drug remdesivir injectable formulation in the country,” he wrote.
Responding to a question on whether remdesivir will be withdrawn from COVID-19 treatment use after its negative impact on the liver has been indicated, Bhushan said that it is a rapidly evolving situation.
“Not only in respect to remdesivir, but in respect of Tocilizumab also, there have been a few studies which have indicated some adverse events. We are aware of this and within the ministry also there is a technical group of domain knowledge experts headed by DGHS that is looking into the evidence as it comes up.
“If there would be a requirement to modify or refine our clinical treatment protocols we will do it,” he said.
The Union Health Ministry in its ”Clinical Management Protocols for COVID-19” has allowed the use of Remdesivir for restricted emergency purposes under “investigational therapies.”
In an answer to a query on plasma therapy, the official said, it has been added as a form of investigational therapy; where it may be used has been specified in clinical guidelines issued by the Health Ministry.
Randomised trials are being conducted under the aegis of ICMR, he further added.