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Pravin Darekar asked FDA to purchase Remdesivir from Bruck Pharma , says Devendra Fadnavis

Fadnavis said the BJP began searching for possible exporters willing to supply Remdesivir to Maharashtra in view of rising Covid-19 cases and the huge demand for the anti-viral drug.

Written by Tabassum Barnagarwala | Mumbai |
April 20, 2021 5:03:22 am
Devendra FadnavisOpposition leader Devendra Fadnavis.

Two days after Mumbai Police summoned a Bruck Pharma director over alleged holding of Remdesivir stock, and Opposition leader Devendra Fadnavis intervened at the police station, the former CM on Monday said that the stock in question was 7,000 vials and it is not in Mumbai but in Daman, and that it would be moved to Maharashtra once the Daman administration gives its approval.

While his party colleague Pravin Darekar – who had visited the police station along with Fadnavis — had said that the BJP intended to purchase 60,000 vials of Remdesivir at the cost of Rs 4.75 crore, Fadnavis denied this while speaking to The Indian Express.

Asked if the BJP’s intention had been to buy Remdesvir and supply it directly to patients, Fadnavis said, “No, in fact he (Darekar) asked FDA (Food and Drug Administration) to purchase the stock from Bruck. But FDA officials said the paperwork will take long and Bruck can supply to licensed stockist and distributors in Maharashtra.” Remdesivir manufacturers or suppliers cannot sell to private individuals or non-government entities.

Fadnavis said the BJP began searching for possible exporters willing to supply Remdesivir to Maharashtra in view of rising Covid-19 cases and the huge demand for the anti-viral drug.

“When we met Bruck Pharma executives, they said they had the capacity to manufacture 20,000 vials per day. But they had to tie-up with a company with marketing authorisation. They also had stock of 7,000 vials that they were willing to supply immediately,” Fadnavis told The Indian Express.

Under the Drugs and Cosmetics Act, 1940, an exporter is not allowed to directly sell stock in the market without marketing authorisation. He has to tie up with a pharmaceutical company that has a marketing licence, in this case from Gilead, which holds the worldwide patent for the drug. Bruck Pharma is in talks with Dr Reddy’s Laboratories for a tie-up to manufacture and supply Remdesivir.

Fadnavis said he reached out to Mansukh Mandaviya, Minister of State for Chemicals and Fertilisers, to expedite the necessary approval to Bruck for supply to Maharashtra.

In a letter dated April 15, Darekar wrote to FDA Minister Rajendra Shingne that several manufacturers are willing to supply Remdesivir to Maharashtra and have asked for local authorisation, and asked the state to “speed up the process on war-footing”.

An FDA official said that soon after India banned export of Remdesivir on April 11, FDA reached out to exporters to check if they had Remdesivir stockpile and were willing to supply. Within a couple of days, Bruck Pharma asked Maharashtra FDA for a local authorisation. FDA granted approval on the evening of April 17.

“The BJP got involved and facilitated the process, but FDA was already trying to get stockpile data from every exporter,” an FDA official said. The same night, Mumbai Police, based on a tip-off about illegal export of the drug, summoned the Bruck Pharma director. A senior joint commissioner (drugs) was also called to the police station. Fadnavis said they went to the police station to understand why the Bruck Pharma director was called for questioning.

Darekar had told the media on April 17 that as “a noble gesture we decided to foot the entire cost of Rs 4.75 crore. Fadnavis was to hand over the Remdesivir stock to Chief Minister Uddhav Thackeray”. On Monday, Fadnavis, however, said they had given a letter to the state asking it to buy the stock of 7,000 vials. “The stock could have reached here in a day, it got complicated because of (all this),” Fadnavis said.

An FDA official said the police are investigating if Bruck illegally moved some stock of Remdesivir to the state before getting local authorisation for sale in Maharashtra. “So far Bruck informed us their stock is in Daman. But it is under investigation,” a senior FDA official said.

Bruck did not respond to calls or text messages.

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