BDR Pharma urges regulators to expedite manufacturing, marketing license process for remdesivir
The company informed that central and state regulatory authorities have carried out an inspection of its API manufacturing site in Vadodara, formulation facility likely to get inspected
Mumbai-based pharma firm BDR Pharmaceuticals has requested Indian drug regulators to expedite manufacturing and marketing license process of remedisivir, a potential drug for COVID-19 treatment.
The company recently signed a contract manufacturing agreement with Cipla for remedisivir.
Cipla is one of the six Indian generic pharma manufacturers who have signed non-exclusive voluntary licensing agreements with Gilead Sciences for its patented drug, Veklury (remdesivir).
Dharmesh Shah, CMD, BDR Pharmaceuticals said, “Amidst the chaos of the COVID-19 pandemic, remdesivir has created a ray of hope amongst the medical fraternity in the country and should be made available on a priority basis. The preliminary results seen in patients who were administered doses of this drug, obtained on ‘compassionate grounds’ from companies in India, have shown positive signs of recovery. This trend has urged medical practitioners to further prescribe this product for other patients who are critical. But, due to the lack of regulatory authorisations, companies are unable to manufacture the drug on commercial scales despite the know-how, resulting in shortage and unavailability. Therefore, we urge regulators to provide the perquisite authorisations for the manufacturing and marketing of this product as soon as possible to increase the accessibility and availability of this drug in the country.”
He also informed that the company’s active pharma ingredients (API) facility in Vadodara which has the capabilities to produce remdesivir has been inspected by Central as well as State drug regulatory authorities on June 10-11. It is likely that in the coming week, the authorities will also carry the inspection of its finished formulation facility, which is again located in the Vadodara, he added.
He said, “We have submitted all the required data to the DCGI office related to our raw material manufacturing site and are waiting to hear from the authority.”
He also informed that the company has enough capacity to produce remedisivir raw material as well as finished formulations. It has the capacity to manufacture 11000 vials in each batch, and it takes three days to complete one batch.
Commenting on the market price of each remdesivir vial, he said, “This is not a time to make money, instead we should ensure drug availability in the market and it should reach each and every needy person in the world. Although we have not yet finalised the price of each vial, we can assure that it will be much cheaper than our neighbouring countries’ price.”