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LATEST NEWS UPDATES | Vaccine probe exposes flawed appreciation by S Viswanathan

Vaccine probe exposes flawed appreciation by S Viswanathan

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published Published on Oct 18, 2010   modified Modified on Oct 18, 2010

The report of the Javid Chowdhury Committee facilitated the resumption, in February 2010, of vaccine production in the three public sector units, one in Himachal Pradesh and the other two in Tamil Nadu. Javid Chowdhury, a former Health Secretary of the Government of India, recommended that the suspension of their licenses for manufacturing vaccines in 2008 should be revoked in the public interest and on the strength of the compliance status reports furnished by the three institutes (‘Online and Off Line,' March 8, 2010).

The Central Government accepted the recommendation and the institutes resumed their functioning. The Committee, at that time, did not understandably go into several other aspects of the crisis created by the suspension of production in these units, which had played a vital and substantial role in providing health care to larger sections of people. Many questions raised by the raw deal meted out to these institutions on “quality concerns” remained unanswered. The final report of the Javid Chowdhury Committee submitted this month to the Union Ministry of Health and Family Welfare answers those questions.

The vaccine-manufacturing units are the Central Research Institute (CRI) located at Kasauli (Himachal Pradesh), the Pasteur Institute of India (PII) at Coonoor (Tamil Nadu), and the BCG Vaccine Laboratory (BCGVL) located at Chennai. The first two are more than 100 years old; the third is a 62-year-old post-Independence institution.

When the three well-run, reputed public sector units that had played a major role in immunising India's millions of children from deadly diseases were abruptly ordered to suspend production more than two years ago, the reasons cited by the Union Health Ministry were unconvincing.

Why on earth were three institutions that took care of the more than 70 per cent of the children under the Universal Public Immunisation Programme at low cost asked to fold up or to downsize their operations — ostensibly on quality grounds — destabilising a highly successful public health programme? And what explains the same vaccine-producing units being put back on the rails without taking any significant “corrective measures” as far as we know? Why should the top personnel in the Ministry play dual roles, indulging in double talk? Who gave them the right to humiliate the dedicated scientists and researchers of these reputed public service institutions? The absence of transparency in such government actions has only led to speculation about the motives.

Ironically, the Pasteur Institute of India had to suffer the ignominy of suspending production in its centenary year. On June 19, 2007, Union Health Minister Anbumani Ramadoss launched a new product manufactured by the Institute to mark the occasion, highly appreciated the crucial role scientists of the institute played in saving millions of lives, and showered praise on their research and related activities. He even wanted them to prepare a road map for the development of the institute. Seven months later, the same Minister told them that “the consensus in the Ministry” was that the entire vaccine production in the country should be centralised at one unit (Frontline, April 11, 2008). Similarly, while the Minister said that the licences of the vaccine-producing units had to be withdrawn under pressure from the World Health Organisation, there were reports that it was the Drug Controller-General of India (DCGI) who had ordered the three units to shut down on the grounds that they were not complying with current Good Manufacturing Practice (cGMP) norms under the Indian Drugs and Cosmetic Rules (D&CR), 1945 (Frontline, April 10, 2009). There were other unanswered questions such as the likely impact of the production stoppage in the three units on the public immunisation programme.

‘Ample evidence'

The final report of the Javid Chowdhuri Committee has answers for some of these key questions. It notes that there is “ample evidence” to show that although the DCGI was reported to have taken the final decision without consulting the Health Ministry, there was ample evidence to show otherwise. “In this background,” the final report says, “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 four-member enquiry committee comprised, besides Mr. Chowdhury, V.M. Katoch from the Department of Health Research, R.N. Salhan, former Additional Director-General of Health Services, and Vincent Chawdhry, Joint Secretary in the Health Ministry, who recently left government service.

The final report has also recorded its observations on the impact of the stoppage of production resulting from the official order. The government did not stop with suspending production; it ordered the three units to ensure that the vaccines manufactured and stored were not sent for use. The shutdown led to a grave shortage in the supplies of vaccine, which badly affected the immunisation programme with the number of beneficiaries falling.

Not coincidentally, private sector units raised the prices, making it difficult even for middle-class families to afford the vaccines. This indictment by the Javid Chowdhuri Committee holds stern lessons for public policy: “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.” The final report, however, registers the hope that the establishment of new IVC together with the installation of new production lines would eventually increase the vaccine availability.

Significantly, the Committee has not failed to record its objection to the Health Ministry's action of allowing the World Health Organisation to inspect the three public sector vaccine units. Noting that this was not the Ministry's mandate, it points out that a similar request had been rejected earlier.

The final report recommends that the Union Government should consider making the three public sector units autonomous, and that a National Vaccine Security Advisory Board should be put in place to advise the manufacturing units. It finds that the suspension of licences to the vaccine units was “incorrect,” based on a “flawed appreciation” of the issue and following an “illegal procedure.”

The Javid Chowdhuri Committee deserves praise for fulfilling its task of fixing responsibility for the Health Ministry's “flawed” moves affecting life-saving programmes designed for the benefit of the poor, particularly children. The press and broadcast media, which covered the subject in detail and on a fairly sustained basis, played a part in spotlighting the issues and having the damaging official decisions reversed. Several newspapers and magazines published good, well-substantiated articles to show the setback caused to the immunisation programme. Some of them pointed to how the vaccine fiasco led profit-hungry vested interests to make a mess of the public immunisation programme in recent years.

But there is no room for complacency about a job well done. Health deprivation is a huge challenge for rising India and the media have lots of hard work to do in terms of uncovering harsh realities on the ground and agenda building for public action.


The Hindu, 18 October, 2010, http://www.thehindu.com/opinion/Readers-Editor/article834599.ece

Tagged with: Health



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