Indian TB vaccine lab set to reopen
The Indian government withdrew the lab's license and ordered its closure nearly four years ago for not complying with good manufacturing practice regulations. It has been shuttered since 2008, despite being the only production facility supplying the Bacillus Calmette-Guérin vaccine to India's Universal Immunization Program, according to TheHindu.com.
The lab plans to send production batches of its vaccine to the Central Drugs Laboratory for testing and, potentially, final clearance. Once cleared, the lab can begin commercial production.
H.G. Brahmne, BCG Vaccine Laboratory's director, said that trial batches have already been sent to CDL and cleared.
"We have to learn from our mistakes, so this temporary closure is, in a sense, good to bring us to international standards," Brahmne said, TheHindu.com reports. "These are exacting and rigorous standards - for microbiology, vial preparation, media preparation, animal house, water for injection plant. We have ensured that all these are strictly adhered to."
Brahmne said that training and refresher programs have been added for all staff, and at least 30 new staff have been recruited to work at the lab.