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Direction issued considering emergency need for COVID-19 treatment, says official
The Haryana government has issued directions for restricted sale and distribution of experimental drugs such as Remdesivir and Tocilizumab, used to treat patients with severe COVID-19 infection, so as to stop irrational use.
An official spokesperson of State’s Food and Drug Administration said that keeping in view the emergency and unmet medical need for COVID-19 disease, the Central Drugs Standard Control Organization (CDSCO) has approved restricted emergency use of Remdesivir injectable formulations for treatment of patients with severe COVID-19 infection.
“The government has also issued directions that Remdesivir formulations are required to be sold under the prescription of medical specialists only. Further, Remdesivir formulations are required to be supplied for use only to hospital-institutions to ensure proper use of the drugs as recommended,” said the spokesperson.
The spokesperson added that it has been reported that during COVID-19 pandemic, doctors are irrationally prescribing the injection Remdesivir, which is approved as an emergency drug by Drugs Controller General of India and to be used in only patients having ICU beds-ventilator for COVID-19 patients management and therefore it should not be prescribed by doctors for patients not admitted in hospitals or in home isolation, having no ICU-ventilators and not prescribed for conditions for which these drugs are not approved.
“Irregular sale of injection Remdesivir or injection Tocilizumab is punishable under Drugs and Cosmetics Act, for which drug licences may be suspended or cancelled. Besides this, any black marketing or hoarding of these drugs is a cognizable and punishable offence, for which stringent action such as registration of FIR will be taken,” added the spokesperson.
The spokesperson said that that all the sellers of these drugs have been directed to strictly comply with the provisions of the Drugs and Drugs Price Control Order (DPCO) read with the Essential Commodities Act, along with sending the details of all purchases and distributions to the State Drugs Controller, Haryana, in the office of Commissioner, Food and Drugs Administration, Panchkula.
“Besides this, they have been directed to restrict sales to dedicated COVID-19 hospitals only, which have ICU beds and critical care facility is provided for management of COVID-19 patients. The drug dealers have also been asked to keep a record of the corona report, an indoor card having mentioned name of the drug and record of the ID card-Aadhaar card for inspection purposes,” said the spokesperson.
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