WITH projection of 11 lakh plus active cases of novel coronavirus by end of April, Commissioner, Food and Drug Administration (FDA), Maharashtra Government, stepped in and directed drug manufacturing companies to ramp up supplies of Remdesivir injections. Abhimanyu Kale, Commissioner, FDA, wrote to M/s Hetro Healthcare Ltd.; M/s Zydus Healthcare Ltd.; and M/s Mylan Ltd., seeking availability of 100 mg injections of the said drug in large quantities citing increasing viral load of COVID19 cases in State.

 

The letter dated April 7, 2021, circulated to all Joint Commissioners of FDA in State spells the trouble some position on COVID-19 pandemic as Kale has given assessment of spike in positive cases together with dates. He further mentions that by April 10 the State might see active cases in range of 5,23,773, by April 15 they would rise to 6,37,250 and by end of month they would be whopping 11,93,557.

 

The prospects of such huge spike in active case loads calls for stocking-up of life savings injections and hence given target of supplies in huge quantity to ensure there is no shortage at hospitals. In identical letters to all three companies, the FDA Commissioner states that between April 10 to 14 the State would need 20,000 vials per day of Remdesivir, from April 15 to 19 the requirement is increasing to 22,000 per day, to 30,000 per day from April 20 to 24, and to 32,000 per day from April 25 to 29 and to 35,000 per day from April 30 onwards. The current viral load in Maharashtra is highest in country even as hospitals are rationalising use of Remdesivir to ensure that only in very serious cases and when count of COVID-19 is beyond clinical management.

 

Underlining the critical scenario, Commissioner pointed out that shortage of Remdesivir might have an adverse fallout on Covid management and also the final outcome to control the current pandemic situation. He also informed the companies that Maharashtra Government has decided to regularise the circulation and supply of Remdesivir injection in the State from the C&F centres of manufacturers.

 

 

CONTROVERSY broke out in city when local retailers directly procured stock of Remdesivir injections from the company by-passing the established chain of drug supplies. With District Administration incommunicado about status of availability of life-saving injections, chemists said, the position is likely to get stabilise in next few days and urged citizens not to panic. FDA officials did not address the issue raised by media as to retail sale of Remdesivir giving a fillip to claims that the pharma industry is too powerful to be regulated by such notifications.The chemists advised citizens not to hoard the injections since they are already in short supply and it would be futile exercise since its shelf life is very less. Meanwhile, on Thursday, some of the leading chemists got limited supplies barring one who directly procured a sizable supply of Remdesivir from the company’s C&F agent in Kalmeshwar area, the sources disclosed. Few other chemists also got stock of Remdesivir but that was in limited quantity and that too ran out within hours. But the one particular chemist in Dhantoli area got over 100 vials of the injection, despite District Collector’s order regulating the supplies to only COVID-19 hospitals and their in-house pharmacies. One of the chemists said that only four to five companies are licensed to manufacture Remdesivir in the country. In city only select few wholesalers stock the critical life-saving injections and said, as per his information the Government-run hospitals have been provided sufficient quantity. The demand-supply mismatch could be resolved in next few days as companies increased production. Since the shelf life of Remdesivir injection is three to four months same cannot be stocked up in advance and as such situation was bound to come to such pass. Now that FDA has taken over supplies the hospitals managing COVID-19 cases would get fresh stock.