‘Sick’ vaccine PSUs get a booster shot

The Centre has revoked its controversial order of shutting down three public-sector vaccine-manufacturing units in January 2008 on allegations of not following good manufacturing practices (GMP).

The Centre has revoked its controversial order of shutting down three public-sector vaccine-manufacturing units in January 2008 on allegations of not following good manufacturing practices (GMP).

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The Ministry of Health had suspended the manufacturing licences of Central Research Institute, Kasauli; Pasteur Institute of India, Coonoor and BCG Vaccine Lab Guindy on grounds that they did not meet GMP norms laid down by the World Health Organisation.

It had led to shortages of essential vaccines between 2008 and 2009, affecting the Universal Immunisation Programme (UIP), prompting the Parliamentary Standing Committee on Health and Family Welfare to recommend the rival of all three at the earliest.

Some of the vaccines being produced included those against DPT, tuberculosis, snakebite, rabies, tetanus, yellow fever, Japanese encephalitis and BCG.

For the UIP alone, India needs 100 million doses of DPT, 200 million doses of tetanus, 100 million doses of BCG vaccine (tuberculosis), 100 million doses of measles, 40 million of Hepatitis B, and 100 million doses of pentavalent combination vaccines.

“The appellant institutes shall ensure that the production line is made fully compliant with GMP standards within three years from the date of the issue of this order,” said the Union health ministry’s order.

“The three-member Javed Chaudhary Committee’s interim report and the impact of the high price and vaccine shortages on the IUP has prompted the government to maintain its own production capacity in the government sector,” said a health ministry official not authorised to speak to the media.

Parliamentary Standing Committee on Health and Family Welfare in its Thirty-Fourth Report tabled in Parliament on 18th February, 2009, and again, in its Thirty-Eight Report tabled on December 18, 2009, recommended the revival of the three vaccine producing PSUs.

Instead of making the three units GMP compliant, the government chose to revoke their manufacturing licences, becoming completely dependent on the private sector for vaccines needed for the IUP,” said Rajya Sabha member Brinda Karat, a member of the Parliamentary Standing Committee on Health and Family Welfare.

“The revocation has come much later than it should have. The standing committee on health under Amar Singh had to take up the matter with the health ministry thrice — last on February 17, 2010 — before they acted on it,” she said.

Before the suspension, against the expenditure of Rs 200 crore for UIP, the three PSUs produced vaccines with Rs 90 crore, excluding the Rs 30-40 crore spent on their running.