After plugging the manufacturing gap, Zydus Cadila is again facing delays in supply of the second batch of its Covid-19 vaccine, ZyCoV-D, News18.com has learnt.
Zydus Cadila was ready to roll out more than 40 lakh doses of ZyCovD.
The company, headquartered in Ahmedabad, had submitted batches containing 35-40 lakh doses of ZyCoV-D for final safety checks at the country’s apex laboratory, Central Drug Laboratory (CDL), in Kasauli, Himachal Pradesh in February.
Of the total batch, more than 8.5 lakh doses have been cleared by CDL for market rollout in the past few weeks.
However, the latest doses were manufactured at the company’s newly commissioned state-of-the-art Zydus Vaccine Technology Excellence Centre at the Zydus Biotech Park in Ahmedabad.
Hence, according to the protocol, the first rollout of substances from the new facility requires a no-objection certificate (NOC) from the Drug Controller General of India (DCGI).
“The doses have been cleared by CDL, Kasauli. This will be the second lot to receive clearances for market rollout after the initial lot of 2.37 lakh doses,” a top government official privy to the development told News18.com.
“However, there is no clarity on why the doses are being held,” the official said.
News18.com reached out to Zydus Cadila via email and text messages for further clarity. However, no response was received at the time of publishing the report.
EARLIER DELAY
ZyCoV-D is touted as the world’s first plasmid DNA intradermal Covid-19 vaccine. It is administered using a painless needle-free system in three doses.
The vaccine received the emergency use licence from DCGI on August 20.
In November, the government had placed an order for supply of one crore doses of the vaccine. After the delays in the rollout due to training for healthcare workers to use needle-free applicators to administer the dose intradermally and scaling issues at its manufacturing site, the company rolled out 2.37 lakh doses in February. These doses were approved by the Kasauli-based lab. The second batch of 8.5 lakh doses is stuck for want of clearance.
Read all the Latest News India and Breaking News here
Comments
0 comment