Even as the controversies and apprehensions continued to dog the three public sector vaccine manufacturing units, the Union health ministry has approved the restructuring plans of BCG Vaccine Laboratory (BCGVL) at Guindy in Chennai and Pasteur Institute of India, Coonoor and promised to put them fully on the track within three years.

The upgradation of vaccine manufacturing facilities at BCG has been approved at an estimated cost of Rs.64.72 crore. The upgradation of DPT group of vaccine manufacturing facilities at PII has been approved at a cost of Rs.149.16 crore, sources said.

The upgradation of the Central Research Institute (CRI) at Kasauli is currently in progress as per the plan and it would be fully functional within a few months. A total of Rs.55 crore is being spent to make it WHO GMP compliant, sources said.

Within two years time, the BCG will again manufacture the anti-tuberculosis Bacillus Calmette-Guerin vaccine after state-of-the-art vaccine manufacturing unit is put in place, according to the plan approved by the Centre. The PII also has submitted a proposal on how to make it GMP compliant and it was approved.

Production of vaccines has restarted in the existing manufacturing facility of CRI. 134.55 lakhs doses of DPT vaccine have been produced in CRI Kasauli till date since the revocation of suspension of licence in February, 2010. Production of vaccine has restarted in the existing manufacturing facilities at BCGVL, Guindy and PII, Coonoor.

“Central Government in exercise of its powers under Sub rules (3) of Rule 85 of the Drugs and Cosmetics Rules, 1945, ordered revocation of suspension of the licences of the these Institutes vide order dated 26/2/2010. These Institutes have also been asked to ensure that the production line is made fully compliant with GMP standards within three years,” according to official information.

The Centre had suspended manufacturing licenses of these three vaccine manufacturing units on January 15, 2008 on the grounds that the units were not in compliance with GMP norms. However, after the public pressure and lots of criticism, the government set up a committee to study the issue and find a solution. The suspensions were revoked on February 26, 2010, based on the recommendations of this panel and gave time to the units to go GMP compliant.