BDR Pharmaceuticals seeks drug controller’s nod to manufacture generic version of Remdesivir, irks Gilead: Report

Raising concerns, Gilead has reportedly written to the Prime Minister’s Office, the Union Health Ministry and NITI Aayog, among others.

Moneycontrol News

May 28, 2020 / 10:16 AM IST

Representative image

Mumbai-based BDR Pharmaceuticals has sought the Drug Controller General of India (DCGI)’s approval to manufacture and sell Remdesivir’s generic version without entering into a licensing pact with Gilead Sciences, according to an Economic Times report.

This has led Gilead Sciences, the patent-holder for the medicine to raise concerns with the government.

BDR Pharmaceuticals had reportedly submitted its application for manufacturing the drug — which is under consideration for treatment of COVID-19 patients — to the Indian drug controller last week.

Gilead has approached the government and questioned the application. It has reportedly written to the Prime Minister’s Office (PMO), the Union Health Ministry, the government policy think tank NITI Aayog, Department of Pharmaceuticals, Department for Promotion of Industry & Internal Trade (DPIIT) and the drug controller’s office.

The report suggested the subject expert committee which is looking into the matter asked the Mumbai-based company to submit details such as the chemistry manufacturing control (CMC) data.

COVID-19 Vaccine

Frequently Asked Questions

How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

Show