There is “ample evidence” that the decision of the Drugs Controller-General of India (DGCI) to suspend the manufacturing licences of three public sector vaccine units was endorsed at the highest level in both the political and bureaucratic line-ups in the Health and Family Welfare Ministry, says the Javid Chowdhury Committee.
In its final report submitted to the Ministry last week, the four-member committee, has concluded that though the DGCI is said to have taken the final decision without consultations with the Ministry, there is ample evidence to show that the Ministry, including the apex levels of the political and bureaucratic executive, was fully in the loop.
“In this background, the only conclusion that the committee can draw is that the Ministry, at its highest political and bureaucratic levels, was associated with the final decision for the closure of the units. Thus, the constructive responsibility for the final decision would also rest on the apex functionaries of the political and bureaucratic executive, including the Union Minister for Health and Family Welfare and the then Union Health and Family Welfare Secretary,” the report has said.
Decision led to shortage
The licences of the Central Research Institute at Kasauli in Himachal Pradesh, the Pasteur Institute of India at Conoor in Tamil Nadu and the BCG Vaccine Laboratory at Guindy, Chennai, were suspended in 2008 during the tenure of Anbumani Ramadoss as Minister, following an inspection by a team of the World Health Organisation (WHO) which said these units did not comply with good manufacturing practices (GMP). The decision led to a vaccine shortage, adversely affecting the universal immunisation programme, and raised a huge debate over the attempts to promote private manufacturers. The then Health and Family Welfare Secretary was P.K. Hota, who has since retired.
The committee noted that at no level was the duty of ensuring a rigorous and objective analysis discharged with diligence. In fact, evidence on record indicates that the conclusion had been treated as pre-decided. Not a single official in the Ministry had identified the different aspects of closure of the units and analysed the issue systematically. “By reducing public-sector vaccine supply to zero, in one stroke a crippling blow had been inflicted on the health security of the country. By closing down the existing public-sector vaccine production units in advance of the commissioning of the Integrated Vaccine Complex (IVC), the country would have exposed itself to vaccine insecurity for five years, or an even longer period,” says the report. The establishment of the new IVC, along with the installation of new production lines at the three existing locations, would eventually increase availability and reinforce the nation's vaccine security.
The report has suggested that the Centre consider making these three public sector units autonomous, and that a National Vaccine Security Advisory Board that would advise it on important issues of vaccine security policy be constituted.
Questioning the Ministry's decision to allow the WHO to inspect the three vaccine units as it was not its mandate and that a similar request had been refused earlier, the committee says the reports on the inspections mentioned deficiencies but not recommended suspension or cancellation of licence.
Set up in September last year, the committee, chaired by Mr. Javid Chowdhury, himself a former Health Secretary, gave its interim report in February this year, describing licence suspension as “incorrect” and based on an “illegal procedure” and a “flawed appreciation” of the issues. It recommended revocation of the suspension, which was subsequently done.
The other members of the committee are V.M. Katoch, Secretary, Department of Health Research; R.N. Salhan, former Additional Director-General of Health Services; and Vineet Chawdhry, Joint Secretary in the Health Ministry who has since demitted charge.
Keywords: Union Health Ministry