New Delhi: The Central Drugs Laboratory (CDL) — the country’s apex drug testing lab — is likely to clear a batch of the Russian Covid-19 vaccine, Sputnik V, within a week, ThePrint has learnt.
The CDL, which is responsible for testing the safety and quality of vaccines for humans in India, has started conducting tests on 100 ampoules (glass vials) of Sputnik V out of a batch of 1.5 lakh ampoules that were imported by Dr Reddy’s, a Hyderabad-based pharmaceutical company.
“We received the batch on 3 May. The testing has already begun on 100 randomly selected single-dose ampoules out of the total imported consignment,” a senior official at CDL told ThePrint.
“The process of clearance and testing has been expedited. However, we need to ensure the safety of the product. Within one week, we will be able to release the vaccine for the distribution to states and UTs, if cleared by the concerned authorities including the Drug Controller General of India (DCGI),” the official, who wished to remain unnamed, added.
On 13 April, India’s drug regulator DCGI granted permission for the restricted emergency use of Sputnik V.
Once it passes all regulatory tests, Sputnik V will be the third vaccine to be available in the country.
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Testing process
The testing of the Sputnik V vials began recently, according to the CDL official quoted above, and the 100 samples were selected randomly by the assistant drug controllers who were on port duty when the shipment landed.
He added that for vaccine testing, usually parallel tests are conducted by the CDL and the manufacturing company.
“On a daily basis, parallel testing is conducted on the samples, where CDL and the manufacturing company both test the random samples and then CDL clears the batch once both reports are reviewed, correlated and cleared,” said the official.
However, since Russia’s national regulatory authority (NRA) has already tested the vaccine, no parallel testing is going on.
“Once the samples are checked for safety and efficacy, we send the testing report to the authorities concerned including DCGI and the Ministry of Health. Next is their call on whether to approve it for further distribution or raise red flags,” he said.
The laboratory, which is based in Himachal Pradesh’s Kasauli, had similarly cleared batches of the two approved Covid vaccines in circulation currently — Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield.
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More vaccines to arrive soon
On 1 May, Dr Reddy’s had announced that the first consignment of 1,50,000 doses of the Sputnik V vaccines had landed in Hyderabad from Russia.
“The rollout of the consignment will be subject to the necessary clearances, which will be processed over the next few days,” the company had said, in a press release.
“This initial quantity will be used across different channels as a pilot to line up our supply chain for the larger vaccination program rollout,” the company added.
More consignments of the vaccine, it further noted, “will arrive in the next few weeks”.
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