Pharmaceutical company Dr Reddy's Laboratories (DRL) has been forced to shut down its laboratories globally after a data breach hit its servers. DRL's facilities in the US, UK, Brazil, Russia and India were affected by the breach, which took place between 4 and 5 pm US time.
The incident comes just days after the company received approval from the Drugs Controller General of India (DGCI) to conduct phase 2 and 3 clinical trials for its redesigned Sputnik V coronavirus vaccine protocol in India .
Dr Reddy's Laboratories and the Russian Direct Investment Fund (RDIF), the sovereign wealth fund in Russia, announced on October 17 that they will conduct a phase 2/3 human clinical trial of the Sputnik V vaccine in India.
This is a multicenter and randomized controlled study, which will also include a safety and immunogenicity study.
Earlier in September 2020, Dr Reddy's and RDIF partnered to conduct clinical trials of the Sputnik V vaccine and distribute it in India. As part of the partnership, RDIF will provide 100 million doses of the vaccine to Dr. Reddy's, subject to approval by the Indian regulatory authority.
"This is a significant development that allows us to start the clinical trial in India and we are committed to delivering a safe and effective vaccine to combat the pandemic," said GV Prasad, chairman and CEO of Dr. Reddy's Laboratories.
“We are pleased to work with Indian regulators and in addition to clinical trial data in India, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial. These data will further strengthen the clinical development of the Sputnik V vaccine in India,” added Kirill Dmitriev, CEO of the Russian Direct Investment Fund.
