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Shardul Nautiyal, Mumbai July 31 , 2020
Based on the talks and assurances given to the Maharashtra Food and Drug Administration (FDA), around 90,0000 remdesivir injections have been supplied across Maharashtra as major manufacturers--Cipla and Hetero---have ramped up production to cater to the increasing number of critically ill COVID-19 patients in the state.

As of today, additional distributors have also been appointed to address the shortage of remdesivir injections faced in parts of Ulhasnagar, Thane and Mumbai.

According to a senior FDA official, “Wholesalers and state-run hospitals are today having stock availability of 5,000 injections on a daily basis. While Hetero has been supplying majorly to hospitals, Cipla has been actively supplying to wholesalers in the state.” As per FDA records, until last week of June, 2020, around 10,176 remdesivir vials were supplied to Maharashtra government.

State FDA team led by Dr Rajendra Shingane, Maharashtra FDA Minister, Rajendra Yadravkar, Minister of State, Maharashtra FDA had made random inspections in hospitals and retail pharmacies amidst reports of shortage and black marketing of essential drugs for the treatment of COVID-19.

Following which Maharashtra FDA started a massive drive to curb black marketing. The state FDA booked 15 black marketers of COVID-19 drugs in the month of July, 2020 for violation of Essential Commodities (EC) Act, Drugs and Cosmetics (D&C) Act and Drug Price Control Order -2013 (DPCO-2013) since July 10, 2020 when it detected first such case in Kashimira of Thane district in Maharashtra.

MRP of remdesivir marketed by Hetero is Rs. 5,400 but consumers have reported it being sold at exorbitant prices ranging between Rs. 15,000 and Rs. 60,000. Drugs Controller General of India (DCGI) has approved emergency use of remdesivir injectable formulation for treatment of suspected or severe lab-confirmed cases of COVID-19. DCGI had earlier issued directives to all state licensing authorities (SLAs) to keep strict oversight on the movement of the stock of essential drugs. As per union health ministry, sale of drugs for the treatment of COVID-19 should be strictly dispensed on the prescription of a registered medical practitioner (RMP).

Considering the emergency and unmet medical need for COVID-19, DCGI on July 2, 2020 had approved restricted emergency use of remdesivir injectable formulations for treatment of patients with severe COVID-19 infection.

Remdisivir formulations are required to be supplied for use only to the hospital/institutions to ensure proper use of the drug as recommended. Informed consent of the patient or his/her representative in the prescribed form is mandatory before initiating the treatment, as per DCGI.

Tocilizumab manufactured by Roche Pharma and marketed by Mumbai-based Cipla is also being used on COVID-19 patients who suffer from extreme immune system response towards the infection, called cytokine storm, leading to multi-organ failure and eventually death.

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