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Three government vaccine units stop production

Ramya Kannan

Vaccine park coming up in Chengalpattu at a cost of Rs.150 crore

CHENNAI: With the Union Health Ministry setting its sights on establishing a comprehensive vaccine manufacturing unit with World Health Organisation’s licence, the three oldest government vaccine manufacturing units in the country have stopped production.

Pasteur Institute, Coonoor, Udhagamandalam; BCG Vaccine Laboratory, Chennai; and Central Research Institute, Kasauli, Uttar Pradesh, stopped manufacturing after the WHO’s National Regulatory Authority (NRA) highlighted deficiency in quality, infrastructure and documentation.

The upcoming vaccine park in Chengalpattu near here will take over the entire vaccine production of the country in a centralised unit. It will be constructed as per global standards at a cost of approximately Rs.150 crore, according to Union Minister of Health Anbumani Ramadoss.

The WHO inspection team had observed that the regulatory procedures followed lacked quality assurance system. There were no definite record procedures and staff and infrastructure were inadequate.

Vaccines that were being manufactured by the institutes include DPT, TT, Japanese Encephalitis, Typhoid, Yellow Fever and BCG vaccines. “One of the major issues that came up during WHO reviews in 2001 and 2004 was the lack of compliance to Good Manufacturing Practices (GMP) as recommended by them,” Braj Kishore Prasad, Joint Secretary, Ministry of Health and Family Welfare, told The Hindu.

Until the last assessment in August 2007, a partial compliance of the requirements was being accepted by the NRA. While the Union Ministry reportedly refused to let the team inspect the vaccine institutes in the initial stages, it had to capitulate when the WHO brought up de-recognition of the Indian NRA and, eventually, stoppage of vaccine exports from India.

The PSUs were re-inspected in the first week of January this year and, as they were “still non-compliant and not in a position to comply immediately,” their licences were suspended with effect from January 15.

Employees move court

Employees of CRI Kasauli have moved the Lucknow High Court against the order to shut down the unit. Naresh Attri, president, CRI Employees Association, claimed the organisation had made a plea to allot Rs.55 crore in order to become a GMP unit as early as 2006, but that was ignored.

Responding to this, Dr. Anbumani said, “At least two of the institutions in Coonoor and Guindy are over 100 years old and the consensus in the Ministry was that we should shift our vaccine operations to one centralised unit that would receive pre-qualification from WHO.”

The new facility would be able to produce vaccines for export as well, competing with the Indian private sector that currently supplies nearly 80 per cent of the developing countries’ vaccine requirement.

However, the existing units would not be disbanded, the Minister said.

Instead, they would serve as testing labs and bottling centres for vaccines and the employees could continue to work in them or shift to the new vaccine plant if they so wished, he promised.

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