New Delhi, Nov. 4 -- India's top drug regulator has denied approval for Serum Institute of India Pvt. Ltd.'s new tuberculosis vaccine, calling the test data "not adequate and conclusive", according to a document and two government officials familiar with the matter.

The Special Subject Expert Committee (SEC) on Vaccines at the Drugs Controller General of India (DCGI) last month found that the main studies failed to clearly demonstrate that the recombinant BCG (rBCG -VPM1002) was effective, according to the minutes of the meeting reviewed by Mint.

A recombinant BCG vaccine is a genetically modified version of the traditional TB vaccine that is based on a weakened strain of Mycobacterium bovis.

The regulator found the Serum Institute of ...