Health ministry orders them to resume production but offers no action plan
About two years ago, the Union health ministry suspended the licences of three state-owned vaccine-making facilities saying they were not complying with the who’s good manufacturing practices (gmp). The vaccine units have now been asked to resume work and get gmp compliance later.
A February 26 directive of the ministry said the Central Research Institute (cri) at Kasauli in Himachal Pradesh and the two facilities in Tamil Nadu—the Pasteur Institute of India at Coonoor and the bcg Vaccine Laboratory in Chennai—are to start production immediately.
The government was prompted to act by members of Parliament who repeatedly questioned the ministry and a public interest petition. The three units were producing low-cost vaccines for the government’s universal immunization programme. Their closure in January 2008 led to an acute vaccine shortage (see ‘Get your own vaccine’, Down To Earth, July 1-15, 2009).
But the order to resume production immediately is hard to implement. Many employees at the Chennai and Kasauli units have retired or moved elsewhere; the tetanus vaccine laboratory and animal houses in cri have been disbanded, said sources. cpi(m) leader Brinda Karat said she was in touch with the employees of the two units in Tamil Nadu. They are nowhere near resuming production, she said.
Reprieve from WHO guidelines
Public health experts who had petitioned the Supreme Court in February 2009 against the closure of the units have sought details on how the ministry proposes to implement its order. Large sums of money are needed to make the units operational. The directors of the three facilities were non-committal on when production would resume.
The ministry’s order has given three years to the vaccine units to obtain gmp compliance from the National Regulatory Authority (nra). It has also asked them to clear existing stocks. Private vaccine manufacturers said the move discredits nra that checks whether vaccine manufacturers follow the guidelines. “We are putting the clock back by two years, especially in the eyes of the who that audited these vaccine units in association with the Indian health authorities and found serious lapses,” said Cyrus S Poonawala, chairperson and managing director of the Serum Institute of India in Pune. “Surely the government cannot violate its own gmp compliance rules and risk the lives of children,” he said, adding the government needs to assess whether the unused vaccine stocks can be salvaged at all. His company and two others had received orders to supply vaccines to the government after the three state-owned units were closed.
Joint drugs controller A B Ramteke justified the opening of the vaccine units without gmp compliance saying, “there wasn’t and there still isn’t any problem with the products.”
Public health experts said gmp compliance is needed only if the manufacturers want to export vaccines. “We met senior who officials who said they are not really concerned with what is produced in India for domestic consumption,” said N Raghuram, one of the petitioners in the Supreme Court case.
Union health minister Ghulam Nabi Azad, while replying to questions in Rajya Sabha last July, had said there seemed a possibility that the public facilities were closed to help the private sector. “I have tried to find out how within two years these public undertakings got paralysed and how the private sector manufacturers increased their prices by 60, 70 or even 100 per cent. This cannot happen in normal circumstances,” Azad had said. Additional secretary heading the National Rural Health Mission, P K Pradhan, refuted allegations of a nexus. “These units are being opened because they will become gmp compliant,” he said.
Mira Shiva, co-convener of a coalition of non-profits, All India Drug Action Network, doubted the government’s sincerity. The ministry plans to introduce pentavalent vaccines (combination of vaccines against diphtheria, pertussis and tetanus) in the immunization programme. These vaccines are not produced by the government units and their introduction may render the three vaccine units redundant, she said.
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