In yet another move to ensure there is no scarcity of two drugs used in COVID-19 treatment -- Remdesivir and Tocilizumab, the department of pharmaceuticals has raised red flag on over-prescription, adding that over-prescription is leading to the drug being sold at higher prices, government sources told CNBCTV-18.
"The department of pharma has asked health ministry urging them to issue guidelines/ advisory or SoPs to curb the over-prescription of these drugs," the sources said.
This move comes after the department of pharmaceuticals took cognizance of complaints where doctors in private hospitals were over-prescribing the two drugs.
"There have been cases where Remdesivir and tocilizumab have been prescribed even in cases where it is not required and hence we have asked the health ministry to work on a mechanism or an advisory through which doctors can be informed about conditions under which the two drugs should be prescribed. ," the sources said.
“Over-prescription is leading to drugs being sold at higher prices. Even hospitals are selling the drug at higher rates. The two drugs also have side-effects and doctors should consider those as well while prescribing,” sources added.
Remdesivir has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) for the treatment of hospitalized patients with severe COVID-19 illness.
The four companies -- Hetero, Jubilant Life Sciences, Cipla and Mylan NV -- with which Gilead Sciences Inc have entered into non-exclusive licensing agreements have got permission from the Drug Controller General of India (DCGI) for manufacturing and distribution Remdesivir in the country.
On July 20, US-headquartered pharmaceutical company Mylan launched Remdesivir under the brand name Desrem in India.
The company has also launched a 24x7 helpline where patients and healthcare practitioners can access information about the drug and its availability.
Priced at Rs 4,800 per vial, the drug will be manufactured at the company’s state-of-the-art injectable facility in Bengaluru, which will work to service the demand in India and other export markets where Mylan has received a licence from Gilead for the commercialisation of Remdesivir, the company had said.
There have been many complaints in the past made to the government regarding scarcity and over-pricing of Remdesivir and Tocilizumab. “While overprescription of Remdesivir & Tocilizumab by Doctors is definitely a concern and leads to additional demand, it is really the unauthorized supply issue that must be addressed on priority by the Government,” said Sachin Taparia, Founder & Chairman, LocalCircles.
Like others, LocalCircles too had raised the issue with the government regarding over-pricing and scarcity of Remdesivir and Tocilizumab in the country.
“We have written to the respective Government stakeholders, asking them to consider implementing end to end traceability for drugs and vaccines prone to shortages”, continued Taparia.
“The model we have proposed is one where the vaccine or drug manufacturer will have to ensure a functional process exists to mark every via with a unique serial number and barcode which can be scanned and tracked at the 2-3 tiers of the supply chain including at the point of final issuance to patient/hospital along with a digital signature of the doctor administering it. Similarly, the process would work for any issued but unused vials to ensure they don’t end up in the black market, something that was found in some cases of Remdesivir black marketing” said Taparia.
It was in June when the government, after allowing restricted emergency use of antivirals Remdesivir and Favipiravir in COVID-19 patients, had issued guidance on the manner of supply of drugs to ensure their proper use. The government had said that Remdesivir injectable formulations allowed for use in severe COVID-19 patients can’t be sold off chemist counters and will only be supplied for use directly to hospitals and institutions.
Later on, The Delhi government's Drug Control Department on July 11, 2020, said that COVID-19 drug namely Remdesivir, Tocilizumab, Favipiravir should only be used for emergency purpose and directed the state drug controller to keep a strict vigil on the matter and check the selling of these medicines to prevent black marketing.
