Concerned over the dwindling quality standard in vaccine production in the world, especially in the developing countries, the World Heath Organisation (WHO) has embarked on a proactive action to bring in quality in vaccine manufacturing in the world. In this regard the WHO has launched an Advanced Training Programme to the senior drug regulators in the developing countries to keep them abreast of the latest quality standards in vaccine production.

The main objective of the WHO is to implement the more stringent ICH guidelines to meet the international standard on vaccine manufacturing in the world, especially the developing world. The first WHO-sponsored Advanced Training Programme was conducted in India which will be followed by other developing countries such as China, Brazil, etc in the coming months.

The WHO's priority on India in this programme is significant in the wake of the closure of three public sector vaccine and sera manufacturing units--CRI Kasuli, PII Coonoor and BCG Vaccine Lab Chennai-by the Indian government reportedly under pressure from WHO for non-compliance of GMP norms.

Earlier, the union health ministry, under pressure from the WHO to streamline the entire drug administration system in the country, had embarked on a series of training programmes for its officials in Canada and US to improve the system on the lines of advanced countries like Canada, US and Europe. The ministry's efforts in this regard came in the wake of serious criticism from the WHO which had in fact warned the Indian authorities of de-recognising India's national regulatory authority. It found serious lacunae in the functioning of the drug regulatory system in India. A WHO team, which minutely assessed the present drug regulatory mechanism in the county some months ago, had found that the Indian drug regulatory authority is not independent and is functioning under pressure.

In India, the Advanced Training Programme was conducted at Pune from December 8 to 12 in which senior Indian drug regulators participated. Senior regulatory experts from WHO were present in the programme to provide the latest information on vaccine manufacturing. The regulators were given training on the possibilities of risk in vaccine manufacturing. The programme also stressed on the need to follow advanced system rather than the traditional system in vaccine manufacturing, a senior official who attended the WHO programme said.