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India converts failing vaccine plants to testing labs

By Nick Taylor, 08-Apr-2008

Related topics: Processing & QC, QA/QC & validation

The Indian government has reacted to the enforced closure of three of its oldest vaccine manufacturing plants by launching a plan to convert them to drug testing laboratories.

The BCG Vaccine Laboratory, Pasteur Institute of India and the Central Research Institute were shut down in January after failing to comply with current good manufacturing practices (cGMP).

However, they will now receive a new lease of life testing the safety and efficacy of drugs and vaccines produced and sold within the country or exported. In addition to this they will be responsible for detecting counterfeit and spurious batches of drugs.

According to data from the Pharmaceutical Security Institute (PSI), in 2006 India was the fifth most common country of origin for fake drugs, after China, Russia, the US and Brazil.

To facilitate the switch the Indian government has set up an expert committee to ensure "the smooth transition of these units into drug testing sites".

This process will include training by drug regulatory experts from Health Canada and the World Health Organization to assist staff in the conversion process.

By retraining staff the government will not have to "lay off any of the staff from these three manufacturing units" Health secretary Naresh Dayal told the Times of India.

Unfortunately in-PharmaTechnologist.com was unable to discover what the workforce is doing prior to the retraining in May.

Their retraining will be a boon to Indian drug testing which is currently lacking in resources, with 26 laboratories available for checking general drugs.

Speaking to the Times of India Dr M Venkateswarlu, former drugs controller general of India, said he believes there is now a six to nine month backlog at each of the plants which results in less then 1 per cent of drugs being tested.

He added: "At present, about 5 per cent of the drugs available in India are counterfeit while 0.3 per cent are spurious. Each of our labs tests 2,500 drug samples annually. Once we have the extra space and technical staff, the labs can test at least 30,000 samples."

Between them the three plants had met the needs of the national immunization programme since its launch in 1978. However, with the oldest of the plants opening 103 years ago and the GMP standards being made more stringent they had to cease production.

The closure of the plants has been on the cards for several years, following criticisms by the WHO following inspections in 2001 and 2004.

Speaking about the WHO after the plant closures the Indian Minister for Health Anbumani Ramadoss said: "In 2007, when things were not to their satisfaction, they warned of derecognising the Indian NRA itself."

The units could have continued to produce the vaccines for the domestic market but Ramadoss said: "Derecognising Indian NRA as a country means even private units that are cGMP certified will not be able to export."

To replace the obsolete plants a centralized 'vaccine park' with modern infrastructure for production and research facilities is proposed to be set up near Chennai.

There has been some debate in Frontline, an Indian magazine, about whether it was necessary to close the plants prior to the vaccine park opening. Whether this fresh start for the plants appeases those opposed to the closures remains to be seen.

In the meantime vaccine production for India's immunization program will be taken up by the private sector.