Gujarat FDA directs companies to restrict distribution of “Remdesivir” only to Gujarat
By Raju Vernekar
Mumbai, April 18:
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 the drug. 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.
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 st 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 fatalities.
Exporter questioned
In another development on Saturday, a Daman(union territory on the outskirts of Mumbai) -based Bruck Pharma Pvt Ltd, an exporter of “Remdesivir”, was questioned by Vile Parle police(Mumbai), since he had stocked nearly 60,000 vials, after the export of “Remdesivir” was banned.” We merely questioned him since the supply of the drug is regulated by the Centre”, a police officer maintained.
However Maharashtra Leader of Opposition (LoP) Devendra Fadnavis(BJP) alleged that the Maharashtra government was harassing the supplier, since the BJP leaders had approached him for supply of the antiviral medication to the state. We had obtained the permission from the Union Minister of State for Chemicals and Fertilisers Mansukh Mandaviya and had also informed the Maharashtra FDA minister Rajendra Shingne about the same, he claimed.
A few days back, the Leader of Opposition in the Maharashtra Legislative Council Pravin Darekar and MLC Prasad Lad (both BJP) had gone to Daman to meet the officials of Bruck Pharma, requesting them to sell their exportable stock into Maharashtra.
But the BJP is being accused of piling the stock of “Remdesivir” in its party offices and distributing them as a party initiative. Recently a stock of 5,000 Remdesivir injections was found in BJP’s office in Surat(Gujarat), which was being distributed free of cost by Gujarat state BJP chief CR Paatil, even as hospitals ran out of stocks of the drug.
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 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”.
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.
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 on Saturday.
