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India’s health ministry is accused of damaging vaccine production

BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b864 (Published 03 March 2009) Cite this as: BMJ 2009;338:b864
  1. Ganapati Mudur
  1. 1New Delhi

    The Ministry of Health in India has undermined the country’s century old legacy of public sector vaccine production, exacerbated vaccine shortages, and jeopardised the immunisation programme, say several healthcare organisations in a complaint to the Indian Supreme Court.

    A petition filed last week wants the court to revoke an order by the health ministry last year that had suspended production of vaccines at three government vaccine manufacturing plants. The ministry had said that the plants did not meet standards of good manufacturing practice.

    The Central Research Institute, in Kasauli, in the northern state of Himachal Pradesh, the Pasteur Institute of India, in Coonoor, Tamil Nadu, and the Vaccine Laboratory, in Chennai, were producing vaccines against diphtheria, measles, whooping cough, polio, rabies, tetanus, tuberculosis, and yellow fever.

    Senior health ministry officials said that inspections at these plants over the past five years had revealed structural, process, and documentation deficiencies.

    But the petitioners have questioned the health ministry’s decision to stop vaccine production at the three plants instead of improving their manufacturing practices.

    “The quality of vaccines is important, but this was a hasty, immature decision,” said Sourirajan Srinivasan, managing trustee of Low Cost Standard Therapeutics, a non-profit charitable trust in the western Indian town of Vadodara. The trust produces generic drugs and campaigns for the rational use of drugs.

    “For a country that has successfully sent a spacecraft to the moon, which would also have demanded high quality control, upgrading facilities at vaccine manufacturing plants should be a picnic,” said Mr Srinivasan, who is one of five petitioners who have approached the Supreme Court seeking the resumption of vaccine production.

    India is among the world’s largest producers of vaccines and uses childhood vaccines worth $150m (£105m; €120m) each year. The petitioners have estimated that the health ministry would have had to invest only 500 million rupees (£7m; €8m; $10m) to upgrade manufacturing facilities at the three plants.

    The petitioners said that the shutdown has come at a time when vaccine production in the three public sector units was peaking and that the gap between demand and supply in India’s immunisation programme had been narrowing. They have also argued that no one had complained about the quality of vaccines from the three plants.

    “The ministry has killed its own production units and virtually invited the private sector to take over the immunisation programme,” said Nandula Raghuram, a member of the Society for Scientific Values, a national watchdog for the preservation of ethics in science and health, another agency in the joint petition.

    “The [quality] inspections at the three units had been going on for many years. There was enough opportunity for the government to make corrections,” Dr Raghuram said. “The issue is: did it have the will to make them?”

    Several states had experienced shortages of vaccines in 2008, such as those for tuberculosis, diphtheria, and tetanus, because private manufacturers were unable to meet an increase in demand.

    The health ministry has asked another public sector company to set up a new vaccine production plant in Chennai that would meet good manufacturing practice requirements. But this facility will take two years to build, and the company lacks the right technology and experience for vaccine production, the petitioners said.

    Notes

    Cite this as: BMJ 2009;338:b864

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