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Remdesivir manufacturers assure Maharashtra FDA of ramping up production as number of COVID-19 cases rise
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Shardul Nautiyal, Mumbai
July 16 , 2020
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Even though there are 51 lakh hydoxychloroquine (HCQ) tablets available in the both the hospitals and retail pharmacies across Maharashtra for COVID-19 treatment, remdesivir manufacturers, Cipla and Hetero, have assured the Maharashtra Food and Drug Administration (FDA) that they will ramp up production in the wake of growing number of COVID-19 cases in the state.
Manufacturers have also assured that around 21,000 vials of remdesivir will also be supplied by next week. State FDA made random inspections in hospitals and retail pharmacies on the availability of essential and lifesaving drugs amidst reports of shortage and black marketing of essential drugs for the treatment of COVID-19.
As per FDA records, 10,176 remdesivir vials were supplied to Maharashtra government.
Among other initiatives, Maharashtra FDA has started 24x7 control room at its Mumbai head office for reporting issues related to black marketing and availability of essential drugs through its toll free number 1800222365 and 022 26592362/26592263/26592365. MRP of remdesivir marketed by Hetero is Rs. 5,400 but consumers have reported it being sold at a price of anywhere between Rs. 15,000 to Rs. 60,000 at many places. DCGI has approved emergency use of remdesivir injectable formulation for treatment of suspected or severe lab-confirmed cases of COVID-19.
COVID-19 drugs approved by Drugs Controller General of India (DCGI) for restricted emergency use are being targeted by black marketers due to demand-supply mismatch. Gujarat Food and Drug Control Administration (FDCA) recently booked a Surat-based drug wholesaler for black marketing COVID-19 drug tocilizumab and sealed the premises in a raid. Maharashtra FDA office stated that there is adequate supply of HCQ based on issuance of over 60 licenses in record time during the lockdown period. HCQ was in big demand due to panic buying during lockdown period amidst reports of its efficacy to treat COVID-19 fuelled with Drugs Controller General of India approval for its clinical trials.
The state FDA based on its report submitted to the DCGI in the month of May 2020 stated that there is stock of 12,61,338 HCQ tablets at government hospital based pharmacies and 19,11,954 HCQ tablets with private retailers and stockists till date.
DCGI had 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).
Hence, the state drug regulator has also issued circulars to all chemists in the state to not sell these drugs without a valid prescription. On April 1, 2020, the Centre made it mandatory for chemists to sell the medicine with doctor’s prescription only by including HCQ drug under Schedule H1 category.
Mumbai and Thane are facing shortage of tocilizumab meant for treatment of severely ill COVID-19 patients. The main reason for the shortage of this life-saving drug is that it is being sold on fake prescriptions, according to the All Food and Drug License Holders Foundation (AFDLHF) which has recently reported the matter to the Maharashtra Food and Drug Administration (FDA).
Tocilizumab manufactured by Roche Pharma and marketed by Mumbai-based Cipla is today 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.
Witnessing its novel use and positive outcomes in the treatment of COVID-19 patients globally, Cipla had been providing tocilizumab injections to Gujarat and Maharashtra.
DCGI recently issued directives to state drug regulators to take steps to curb black marketing of COVID-19 drugs like remdesivir.
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