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Chennai based BCG vaccine Laboratory to restart manufacture of multi-dose vials of anti-tuberculosis

Chennai based BCG Vaccine Laboratory has applied to the directorate of drugs control for a commercial licence to restart manufacture of multi-dose vials of anti-tuberculosis after the experiment batches of the anti-tuberculosis vaccine manufactured in the company’s new building were declared consistent and of standard quality by the Central Drugs Laboratory in Kasauli. Six batches of the vaccine manufactured between January and March were tested and found to be of standard quality.

The manufacturing of the vaccine is being done to aid the center’s immunization programe as the lab has the capacity to manufacture 800 lakh doses of the required 1,200 lakh doses of the medicine which is expected to bring down the cost of the Centre’s immunization programme by up to Rs 10 per vial.

The lab tried to manufacture the vaccine previously also from the old building, but due to quality issues it failed. Hence in 2013, the lab started constructing a new building keeping in mind the GMP requirements and received the certification in 2016 from the Central Drugs Standard Control Organisation to start the trial vaccine production. However in December 2016, a cyclone called Vardah led to power disruptions which destroyed the test doses and hence the test doses could not be sent to the Central Laboratory. Some of the equipments were also damaged and it took a long time for the company to arrange the spare parts and had to begin the entire process from scratch.

Three labs namely BCG, Pasteur Institute Ooty and CDL Kasauli were ordered to close down on account of WHO GMP violations in the year 2008 by the Union Health Ministry which in turn raised the prices of the drugs for the vaccination program. However the suspension of the licenses was revoked in 2010 again on the condition that the lab put in place WHO approved GMP protocol and infrastructure.