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4.5 lakhs doses for universal immunization rolled out by the Chennai based BCGVL

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Posted on : 01/Aug/2020 10:56:55 AM



 
 
 
Non-compliance with the good current Good Manufacturing Practise or cGMP has resulted in the suspension of the license of Chennai based BCG Vaccine Laboratory or BCGVL and that happened 12 years ago.

The latest news is the first batch of 4.5 lakh doses of the universal immunization program has been rolled out by this Chennai based BCGVL. Till March 2021, this company is planning to supply 170 lakhs doses of vaccine. It was in 1948 the lab came into existence under the purview of the Union Ministry of Health and Family Welfare. Assistance was received from SSI or Statens Serum institute belonging to Denmark.

It must be noted that the seed strain used at BCGVL was received from SSI through the World Health Organisation for the production of the BCG vaccine against childhood tuberculosis and supply for the immunization program. In the month of January in 2008, the non-compliance with the cGMP and its manufacturing license along with those of public sector vaccine manufacturing units were suspended.

In February 2010, the suspension was revoked by the Union Ministry for Health and Family Welfare. In 2012, the construction of a new cGMP facility began and in 2016 it was handed over to BCGVL.

Trial production was carried out and the vaccines were analyzed for quality by the central drug testing laboratory of CDSCO. The joint inspection was conducted by CDSCO (state licensing authority, the National Regulation Authority) and by experts belonging to Central Drugs Laboratory at Kasauli.

In October 2019, the commercial license was issued by the State Licensing Authority after scrutinizing the facility, production process, records, and other documents, etc. In July, CDL certified the batch to be of standard quality.

First batch of the vaccine was flagged off by Shanti Gunasekaran, deputy drugs controller, CDSCO. The flagging off event also saw the presence of Mr. T.F. Hassan director in-charge and B. Sekar consultant of BCGVL.
 
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