The Union Health Ministry on Saturday released an updated clinical management protocol for COVID-19 cases. This includes the advice to use dexamethasone as an alternative to methylprednisolone for managing moderate to severe cases.
“The change has been made after considering the latest available evidence and expert consultation,” noted a senior official of the Ministry.
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Dexamethasone is a corticosteroid drug used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects. The drug was tested in hospitalised patients with COVID-19 in the ‘RECOVERY’ clinical trial in the United Kingdom and was found to have benefits for the critically ill patients and reduce mortality by one-third for patients on ventilators and one-fifth for patients on oxygen therapy. The drug is also a part of the National List of Essential Medicines (NLEM) and is widely available.
Union Health Secretary Preeti Sudan has forwarded the updated protocol to all States and Union Territories for making arrangements for the availability and use of dexamethasone at the institutional level too.
Meanwhile, the All India Drug Action Network, comprising several non-governmental organisations working to increase access to and improve the rational use of essential medicines, has written to the Centre on the lack of transparency about the COVID-19 Subject Expert Committee and approval of COVID-19 drugs.
“We are writing in reference to the lack of transparency about the Subject Expert Committee (SEC) that we understand has been formed to evaluate COVID-19 drugs and health products and the approval process for COVID-19 drugs. The COVID-19 SEC has been involved in reviewing the applications for regulatory approval of drugs to treat COVID-19. In particular, the COVID-19 SEC had made recommendations in respect of remdesivir and favipiravir, which subsequently were granted marketing approval by the Central Drugs Standard Control Organisation (CDSCO). We are deeply concerned that other than selective information available through the media, there is no information in the public domain regarding the COVID-19 SEC’s deliberations, recommendations or any reservations that the committee may have had about large-scale sale of these drugs in absence of relevant data,” notes the letter.
“This violates basic requirements of transparency and the right to information from India’s drug regulator and is contrary to the CDSCO’s own practices regarding the functioning of SECs,” the group has said.
