US pharmaceutical giant Gilead Sciences is likely to apply to India's Central Drugs Standard Control Organisation (CDSCO) soon seeking marketing authorisation for its anti-viral drug remdesivir, which is being considered by many as a potential medication for COVID-19.
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Officials of the Union Health Ministry, along with the Drugs Controller General of India (DCGI) held a discussion with the representatives of Gilead Sciences on May 20 to prepare a road map for introducing remdesivir in India, sources said. "The US-based company is keen on applying for granting of marketing authorization for its drug remdesivir in India. They were apprised about the regulatory procedures for granting of approval to a new drug in the country and were assured of total facilitation. "The company representatives said they will get back after discussion with their board of directors," an official said.
The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) to treat hospitalised COVID-19 patients. Regulatory approval under exceptional pathway was granted by the Japanese Ministry of Health, Labour and Welfare on May 7, on the basis of clinical data from the US. "On the basis of approvals granted by USFDA or any other reputed regulator, the Indian regulator can approve the drug by waiving off clinical trials in special circumstances in accordance with the provisions of the New Drug and Clinical Trial Rules 2019," a source in the know of the developments said.
The efficacy of remdesivir was discussed in a recent meeting of the joint-monitoring group (technical committee) headed by the Directorate General of Health Services (DGHS) and the use of the drug on COVID-19 patients was not approved due to lack of enough scientific evidence at that stage. "In a recent meeting it was decided that since redmdesivir is one among the four treatment protocols that are being evaluated during the randomised controlled clinical trials under WHO's solidarity trial to find an effective treatment for COVID-19 across several countries, we may wait for its outcome before deciding inclusion of this drug in national treatment protocol," a source said.
The other three treatment protocols are hydroxychloroquine, a combination of lopinavir and ritonavir, and also combination of lopinavir and ritonavir with interferon beta-1a. Gilead Sciences Inc have entered into non-exclusive licensing agreements with pharma firms including three domestic majors Cipla, Jubilant Life Sciences and Hetero for manufacture and distribution of Remdesivir. It has been learnt that these companies will be able to start supplies earliest from July/August even if they are given fast-track approvals in May, the source said.
The Health Ministry had earlier written to Gilead Sciences Inc to supply drugs for use on trials for 1,000 patients at AIIMS. But the company on May 12 said the best approach for India to participate in a remdesivir clinical trial is through WHO's 'solidarity trial' being undertaken in multiple countries, including India, in which remdesivir is one of the five drugs being tried.
The Indian Council of Medical Research had earlier said anti-viral medication remdesivir which was used during Ebola outbreak may inhibit the SARS-CoV-2 replication and research on its efficacy in the treatment of COVID-19 is a part of the WHO's 'solidarity trial.' According to a recently published study in the New England Journal of Medicine, two out of three critically ill coronavirus patients who were on oxygen support or on ventilators showed signs of improvement when they were administered remdesivir.
The New Drug and Clinical Trial Rules, 2019, provides for certain clauses, according to which the provision of waiver of local phase-III clinical trials of the drug is approved and marketed in certain countries (as notified from time to time) subject to certain conditions and confirming conduct of phase-IV study, a source explained. The phase four study requirement could be reduced in case of drugs of special relevance, in case of unmet need, for rare disease for which drugs are not available or available at a high cost or orphan drugs.