A confidential internal health ministry inquiry report––available with Deccan Herald––clearly states that the responsibility for the decision would rest on the then health minister and the then health secretary P K Hota. “The crunch decision was endorsed at the highest levels in both the political and bureaucratic executive line-up of the ministry. The decision to suspend licenses were both illegal and flawed,” it said.
The units – Central Research Institute, Kasauli; Pasteur Institute of India, Conoor and BCG Vaccine Laboratory, Guindy–were shut down in 2008. The shortfall in vaccine production was to be met by procuring them from the private sector, which later jacked up the prices.
Ramadoss ordered the closure citing these PSUs’ “failure in meeting WHO’s good manufacturing practice (GMP) norms.”
However, the probe report now questions the jurisdiction of the WHO on the Indian regulatory authority, Drugs Controller General of India (DCGI), which did not find any problem with these public sector units.
Interestingly, it was Ramadoss who approved association of WHO inspectors with the DCGI team that inspected these units on the basis of a note sent by Hota.
The units were shut down on the basis of the WHO report. However, the probe report states “many deficiencies pointed out during the inspections are minor in nature” and “evidence on record indicates that the conclusion had been treated as pre-decided.”
As a replacement to those PSUs, Ramadoss planned to set up a integrated vaccine complex at Chengallapatu, close to Chennai. To be established by Hindustan Latex Ltd, it was to house private sector vaccine companies to produce UIP vaccine following WHO norms. However, after Ramadoss’s departure, the future of the project is in limbo as the Centre has revoked the suspension of manufacturing licenses for these three units.