Bharat Biotech bypasses red tape, gets KSPCB nod for Covaxin production

BENGALURU: Bharat Biotech on Thursday got approval from the Karnataka State Pollution Control Board (KSPCB) to start production of Covaxin at the existing Bharat Biovet unit in Malur, near Bengaluru. But it was not without Bharat Biotech having to go through a struggle — withdrawing its first application and filing another afresh to bypass the red tape the earlier application got entangled in. This, despite the urgency of the pandemic-induced crisis requiring fast-tracking of the procedure.

The fast-tracking was instead done by Bharat Biotech on technical grounds, to start production of Covaxin vials at the earliest, from an already operational facility run by its partner firm Bharat Biovet. It currently produces Foot & Mouth Disease vaccines here.As per documents available with TNIE, KSPCB gave approval for establishing a separate unit to Bharat Biotech on May 21, 2021, based on its first application. But Bharat Biotech withdrew the application and stated that they had changed their plan, and entered into an agreement with Biovet to cut the red tape.The company had earlier applied under ‘orange category’ (lesser polluting category) under the fermentation category. But KSPCB officials raised a flag, saying it was a pharma industry, and hence comes under ‘red category’ (highly polluting category). It is the same category under which Serum Institute of India in Hyderabad got permission. Sputnik-V also got permission from KSPCB to set up a unit in Jigani, Bommasandra, under ‘red category’ in May.

Sources from Bharat Biotech informed TNIE: “A month ago, an application was filed to set up a new unit. But the file got caught in red tape. Since it is in national interest, we decided to change the application and partner with Bharat Biovet to get permission under the expansion clause.”As per the fresh application, the Biovet facility at Malur will be expanded for Bharat Biotech to start producing Covaxin, and reduce production of Biovet’s Footh & Mouth Disease vaccine.  KSPCB permitted Bharat Biotech’s application to reduce production at Biovet from 50 million vials to 17 million vials, while producing 30 million vials of Covaxin and eight other varieties of vaccines, with production capacity of three million vials per year. The consent for mixed production has now been given till June 30, 2026.KSPCB gave permission on the condition that all environmental norms will be adhered to, and drug production should not exceed the said capacity, a government official said.

KSPCB Chairman Brijesh Kumar said: “The revised application was submitted to the regional office in Kolar four days ago. It came to the head office on Wednesday and was signed on Thursday. Environmental clearance from principal secretary, environment, consent for establishment and operation was also given. Following guidelines by the Ministry of Environment, Forest and Climate Change (MoEFCC), environmental clearance scrutiny has been relaxed, but not eliminated.”The signed approval will be uploaded on Friday and Bharat Biotech will be allowed to start manufacturing, provided machinery is ready and in place for production of Covaxin.