Dr Reddy’s hopes to submit Sputnik V Light trial data to DCGI next month
Hyderabad: Hyderabad-based pharmaceutical company Dr Reddy’s on Friday said it hopes to submit phase 3 trial data of Sputnik V Light, the single dose vaccine, to the Drugs Controller General of India (DCGI) next month. The company is also starting trials on children in two cohorts involving children of the age groups of 2-12 years […]
Hyderabad: Hyderabad-based pharmaceutical company Dr Reddy’s on Friday said it hopes to submit phase 3 trial data of Sputnik V Light, the single dose vaccine, to the Drugs Controller General of India (DCGI) next month.
The company is also starting trials on children in two cohorts involving children of the age groups of 2-12 years and 12-18 years.
Dr Reddy’s CEO API and Services Deepak Sapra said the company is in discussions with the drugs regulator to conduct trials on introducing Sputnik V as a booster dose. The company has already finalised the protocol and intends to use the booster dose for fully vaccinated people with any vaccine, with a gap of six months.
The trials of Sputnik as booster dose and paediatric dose are being carried out by Russian Direct Investment Fund (RDIF) outside India, while the trials in India may begin next month.
In addition to meeting the domestic requirement, the company is in discussions with its partners to take the vaccine to Africa, Asia Pacific and Latin America.
Dr Reddy’s said, out of the six manufacturing sites producing Sputnik V vaccine, four have begun manufacturing the first component, and only two manufacturers have begun making the second component. The company holds the sole distribution rights for the first 250 million doses of the Sputnik V and Sputnik Light vaccines in India, as per its agreement with the RDIF.
The Indian manufacturers have gone through the complete technology transfer for Sputnik V and all the vaccine doses currently administered in the country are entirely Made in India. From September onwards, production has been ramped up and there are no supply chain constraints, the company said.
In terms of other products in the Covid portfolio, the company said it expects to complete molnupiravir trials this year. The company has received regulatory approval for conducting an expanded trial for 2-DG for patients in the non-hospital setting. As of now, 2-DG has been granted EUA as an adjunct therapy to standard-of-care treatment of hospitalised patients with moderate to severe Covid-19.
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