INDIA. Mumbai: While the Union Government has banned the export of anti-viral drug “Remdesivir” injection and “Remdesivir Active Pharmaceutical Ingredients” (API), being used to cure COVID-19 patients, the restrictions on its inter-state distribution has led to a war of attrition between the Maharashtra leaders and the Centre.
Maharashtra minister Nawab Malik on Saturday alleged that the Centre is denying permission to companies willing to sell “Remdesivir”. 16 export-oriented units have 20 Lakh vials of “Remdesivir”. These units are seeking permission to sell this medicine within the country but the central government is denying the same,” he wrote on Twitter. These companies have been warned that their license will be cancelled if they sell the drug outside their jurisdiction, Malik added.
In support of his claim, Malik produced a letter (No FDCA/BDR/BOREM/DOM Diversion/2021-3150/B dated April 12, 2021) written by Gujarat Food and Drugs Control Administration, to M/s BDR Life Sciences Private Limited, Vadodara, stating that its request for despatch of 142000 vials of “Remdesivir” (manufactured by BDR Pharmaceutical International Limited at Lyka Labs under loan license) for export purpose is approved and it is permitted to distribute the drug under emergency and very high demanding situation of COVID-19 pandemic “for Gujarat Government supply or trade-in Gujarat” only.
“The government says that “Remdesivir” should be sold only through 7 companies that are producing it. But these 7 companies are refusing to shoulder the responsibility, Malik, who is also the National Spokesman of the Nationalist Congress Party, said. While there is a requirement for this medicine and it is available, a quick decision is the need of the hour. This problem must be solved and the vials must be supplied to government hospitals in all states immediately”. The Maharashtra Government will have no choice but to seize the stock of “Remdesivir” from these exporters and supply it to the needy”, he added.
A letter from the Gujarat FDA to a pharmaceutical unit directing it to restrict the sale and distribution of “Remdesivir” only to Gujarat((Photo credit: Nawab Malik on twitter)
Malik also slammed Prime Minister Narendra Modi for the rising number of COVID-19 cases and deaths across the country, saying that if the vaccination certificates carry his photo, then the death certificates of the COVID-19 victims should also carry his image. He further stated that if the Prime Minister wants to take credit for vaccination then he should also take responsibility for COVID-19 fatalities.
Black-marketing
With the unprecedented rise in Covid-19 cases, demand for “Remdesivir” has shot up leading to the long queues outside pharmacies. Black marketing of medicine is also on the rise. The anti-viral injection priced between Rs.1000 and Rs.5,500, is being sold for Rs.30,000 to Rs.40,000 or even more in the black market.
In the last few days, the police have arrested over a dozen people in and around Mumbai and other parts of the state, on charges of black marketing “Remdesivir”. Recently on April 13 three men-Rizwann Arif Mansoori(32), a BUMS doctor working in an ambulance, Siddharth Yadav ( 21), a student and Shivpujan Vishwakarma(28), a medical representative, were arrested red handed by the officers of the Food and Drugs Administration, Maharashtra and the Malwani police, while they were in the process of selling the injection for Rs 60,000 per vial.
An investigational therapy
In “National Clinical Management Protocol for COVID-19″, “Remdesivir” is listed as an Investigational Therapy, i.e. where informed and shared decision making is essential, taking into consideration, the contraindications mentioned in the guidelines. The protocol based on evidence has been developed after many interactions by the Committee of Experts and is the guiding document for the treatment of COVID-19.
Niti Aayog member Dr. VK Paul earlier this week had said that it should not be used for patients at home. The patient has to be on oxygen therapy, and the drug is supposed to be supplied only to hospitals and not to be sold in retail. It is not meant for everyone,” he said.
Maharashtra’s food and drug administration (FDA) minister Rajendra Shingane on Friday said that the state will face a shortage of 12,000 to 15,000 Remdesivir injections. The pharmaceutical companies manufacturing “Remdesivir” have stepped up production but it will take time for the new stock to reach the market. The Remdesivir-making companies could provide only 37,000 to 39,000 vials to the state till April 15, although the heads of these companies had assured to supply around 55,000 vials.
“Remdesivir” now at Rs 899 per vial
In the meanwhile, the “Remdesivir” will now be priced at Rs 899 per vial with the National Pharmaceutical Pricing Authority(NPPA) under the Department of Pharmaceuticals declaring a change in prices for seven brands of “Remdesivir” injections of potency 100 mg per vial, on Saturday. Seven Indian companies are producing “Remdesivir” under a voluntary licensing agreement with Gilead Sciences, USA. They have an installed capacity of about 38.80 lakh units per month.
As per an office memorandum issued by NPPA, the prices have been slashed in the range of Rs 1,000 to Rs 2,700. After the price cuts, “Cadila Healthcare”s “Remdac” continues to be the cheapest and will cost Rs 899 per vial. Earlier the injection was being sold at Rs 2,800. “RemWin” by “Bharat Biologics India’s Syngene International” will now be available at Rs 2,450 instead of Rs 3,950. “Redux” by “Dr. Reddy’s Laboratories” will now cost Rs 2,700, half of its earlier price of Rs 5,400. “Cipla” has slashed the price for its “Cipremi” to Rs 3,000 from Rs 4,000.
“Mylan Pharmaceutical” has revised the price for its injection “Desrem” to Rs 3,400 from Rs 4,800. “Jubilant Generics” has reduced the price of its “Jubi-R”, to Rs 3,400 from Rs 4,700. “Hetero Healthcare” will sell its injection “Covifor” at Rs 3,490 instead of Rs 5,400.
In view of the shortage, the Union Minister of State for Chemicals and Fertilisers Mansukh Mandaviya had held meetings with drug manufacturers and other stakeholders on April 12 and 13 in which decisions to increase production and reduce the prices of “Remdesivir” was taken.
“The current total installed capacity of the seven manufacturers of “Remdesivir” is 38.80 lakh vials per month. Fast-track approval has been given for seven additional sites having a production capacity of 10 lakh vials per month to six manufacturers. Another 30 lakh vials per month production are lined up. This would ramp up the production capacity for manufacturing to around 78 lakh vials per month,” a government statement said.
