“The export embargo still exists. They (government) are giving special permission (for exports) once you apply. There are challenges on the regulatory front. Still Sputnik Light is not approved in India. Dr Reddy’s is doing clinical trials now, they are expected to complete by this month. By November both export embargo and clearance on the licensing should be cleared,” Srinivas Sadu, Managing Director of Gland Pharma told analysts at the company’s recent Q2FY22 earnings call.
“As soon as the manufacturing license is received, and export restrictions are removed, we will initiate (commercial) manufacturing,” Sadu said.
According to RDIF, Sputnik Light has been authorized in more than 15 countries with the registration process ongoing in a further 30 countries.
As per the contract signed with RDIF- the Hyderabad-based drug maker can manufacture upto 252 million doses of the Sputnik V and Sputnik Light vaccines.
Sadu said the company has completed three submission batches for Sputnik Light. Submission batch is manufactured to generate data, intended to be submitted to the regulator for the purpose of seeking the regulatory approval.
On Sputnik V – the company said it has completed the submission batch of the first component and the exhibit batch of the second component.
Gland Pharma said it is currently focusing on rolling out the single shot Sputnik Light vaccine. Sputnik Light is nothing but the first dose of Sputnik Light.
“Our focus is on Sputnik Light, that’s where the demand is coming now from outside of India. First few months we would focus on Sputnik Light, post that we will shift to Sputnik V,” Sadu said.
ET has earlier reported that companies have switched focus to Sputnik Light, as they are facing issues of low yield on Sputnik V second component.