The Centre has told the Supreme Court that Indian missions all over the world have been working on a war footing for sourcing medicines like Amphotericin or additional and alternative drugs for the treatment of COVID related Mucormycosis (CAM) in the country.

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The Union health ministry, in a 375-page affidavit filed in the apex court on 26 June, responded in detail to the query of an apex court bench about the steps being taken to ensure drug availability for Mucormycosis. It said the projected production of L-Amphotericin B by domestic manufacturers in August is likely to be 5.525 lakh units of injections and in order to maintain equitable distribution, states are given the medicines in accordance with the proportion of their reported caseload. Besides ramping up domestic production facilities of medicines like Amphotericin, the government said it has also issued guidance on the judicious use of the drug, and states and UTs have been required to put in place transparent arrangements for allocation to private and government hospitals.

The drug Amphotericin is available both through domestic production and by imports, and both sources have been ramped up. The capacity and supply have had to be increased manifold in a very short period of time to cope with the surge in demand seen for the first time in May and June 2021. "Further, allocation is being made as an interim measure to enable equitable distribution across states, using patient data of Mucormycosis as reported on the portal created for this purpose by MoHFW (Ministry of Health and Family Welfare), it said.

The affidavit said in order to augment domestic manufacturing, the Centre has been continuously engaging with manufacturers to resolve issues related to raw materials. In this regard, the Ministry of External Affairs (MEA) is playing a critical role in reaching out to various manufacturers abroad, and with the active participation of MEA, several important and critical steps have been taken to augment both domestic production and imports. It may be noted that vide OM dated 16.05.2021, MHFW had requested MEA to explore all possibilities of sourcing Amphotericin B/Liposomal Amphotericin B injection from abroad through Indian Mission.

"Accordingly, MEA has also instructed Indian Missions all over the world to immediately identify additional sources of the drug and alternative drugs for the treatment of Mucormycosis. The said exercise is in process at war footing, it said. In order to augment domestic production, the Department of Pharmaceuticals and the Drug Controller General of India has actively coordinated with the industry for the identification of manufacturers, alternate drugs and expeditious approvals of new manufacturing facilities, the affidavit said.

The DCGI after consultation with the association of Drugs manufacturers has recently issued manufacturing/marketing permission of Amphotericin B Liposomal Injection to eleven companies so as to augment the production which would be available. Some of such 11 companies have already started producing and some are commencing production from July 2021, it said. The affidavit also dealt with the availability of Remdesivir and said that looking at the sudden increase in demand for the patented drug in April 2021, the central government had made efforts to augment the production by the seven licensed domestic manufacturers.

The domestic production capacity was augmented from 38 lakh vials per month to nearly 122 lakh vials per month with the accelerated approval of 40 additional manufacturing sites by the DCGI (Drug Controller General of India) taking the number of sites to 62, it said. The government also undertook allocation of the drug to all the states and UTs in a move to ensure fair and equitable distribution for an interim period till production was ramped up and the drug became adequately available in the market, it said. Beginning with the first distribution to states and UTs on April 21, 2021, to the last allocation made on May 23, 2021, the total cumulative allocation of 98.87 lakh vials of Remdesivir was made to them, it said.

Meanwhile, noting the slowdown in the demand of Remdesivir owing to a decrease in the number of active cases and sufficient availability of the drug with States/UTs, allocation by the Government of India has been discontinued at the end of May 2021, and states / UTs can purchase as per their requirement from the manufacturers, it said. Dealing with the availability of Tocilizumab, the Centre said, this medicine is listed in the treatment protocol for the management of COVID 19 patients. Since the drug is not manufactured in India it is sourced from a company Roche in Switzerland and marketed by Cipla Ltd in India. "Till about March 2021, the demand of Tocilizumab by various hospitals across the country was adequately being met until the sudden spike of COVID cases April 2021 onwards whereby the demand for the drug went up hugely, it said.