DR. REDDY LABS APPLICATION FOR PHASE-3 CLINICAL TRIALS FOR THE RUSSIAN SPUTNIK VACCINE REJECTED; DCGI ISSUES RECOMMENDATIONS

 



Hyderabad: Dr. Reddy Labs have tied up with the Russian vaccine manufacture Sputnik in hopes of using the vaccine on Indian citizens. The application was summarily rejected by the Drug Controller General of India, and it issued recommendations to the company to resubmit the application to conduct Phase-3 clinical trials. The company had earlier submitted an application to directly Phase-3 clinical trials with the Sputnik vaccine and Central Drugs Standard Control Organization formed an expert committee and the committee recommended the pharmaceutical company to combine Phase-2 and Phase-3 clinical trials in order to be granted the approval by the drug bodies if the trials end up successfully.

Sputnik vaccine had been manufactured in Russia and was also administered to the Russian President’s Vladimir Putin’s daughter. The health experts and the world is not fully aware on how the Russia conducted clinical trials with Sputnik or the effectiveness of the vaccine against the coronavirus. Last month, Russian President Vladimir Putin had said that he hopes to distribute the vaccine with all countries who requests it. As of now, several vaccine candidates are in different developmental phases around the world.

As the biggest vaccine manufacturer in the world, India holds a key position in manufacturing an effective vaccine to defeat the coronavirus. Serum Institute of India, the world’s largest vaccine manufacturer has tied up with Oxford University and the British pharmaceutical company AstraZeneca to manufacture the coronavirus vaccine. Prime Minister Modi had said this week that the Indian vaccine is meant for all of the humanity and not just for the Indians. The experts had expressed their doubts as to how India the second most populous country in the world is planning to distribute the vaccine, permitting the successful trials of the said vaccine.

Russia will provide 100 million doses of its Sputnik V vaccine if the vaccine successfully goes through clinical trials and obtain approval from all the relevant drug regulatory bodies in Indian government.

 


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