Hyderabad-made, J&J’s Jabs Get CDL Nod, Over 1 Cr Doses Ready for Export

News18.com has learned that Johnson & Johnson’s Covid-19 vaccine shots, manufactured in India by Hyderabad-based Biological E, are ready for export.

The country’s apex laboratory, the Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh, cleared six batches of more than one crore doses for safety last week.

“The doses have been cleared by the CDL in Kasauli. The company has expressed the intent to export those doses. According to Form 28 (required for the grant of licence) filled by the company, the vaccine will be exported,” a senior government official at the Ministry of Health and Family Welfare told News18.com. “Once the Drug Controller General of India (DCGI) approves the report sent by CDL and the request filed by the company, the batches can be exported.”

The move is in line with Prime Minister Narendra Modi’s announcement at the Quad Summit in September.

“India will make available 8 million (80 lakh) doses of the Johnson & Johnson vaccine by the end of October under the Quad vaccine partnership,” Foreign Secretary Harsh Vardhan Shringla had said while adding that PM Modi had made an announcement to the effect at the summit. Shringla also said that the Quad nations, including India, will pay for the vaccines.

Since September, the vaccine batches were stuck at the CDL due to pending data, News18.com had reported earlier.

“Finally, the pending data was submitted by the company late October. Last Friday, the report by CDL was received by the DCGI’s office clearing the vaccines for safety,” said the official quoted above.

A Johnson & Johnson India spokesperson told News18 that it is “premature” to speculate on the timing of vaccine deliveries. “Our teams are working around the clock to develop and broadly activate our manufacturing capabilities to supply our Covid-19 vaccine. We believe Biological E will be an important part of our global Covid-19 vaccine supply chain network, helping to supply our vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organisations such as Gavi and the COVAX Facility. It is premature for us to speculate on the timing of our vaccine deliveries,” the spokesperson said.