The World Health Organisation (WHO) has 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, has found that the Indian drug regulatory authority is not independent and is functioning under pressure, according to sources.

Taking serious note of the loose regulatory mechanism in the country, the WHO has asked the Indian health ministry officials to undergo training in an advanced country to understand how the regulatory system is working in those developed countries. Under the WHO direction, an Indian health ministry team, including Drug Controller General of India (DCGI) Dr Surinder Singh and joint secretary in the health ministry Devashish Panda, is leaving for Canada on April 26 for a week-long training. The Indian health ministry officials will study the regulatory system in Canada, especially the new drug review procedure, and how it can be adopted in Indian scenario.

The WHO has also taken strong objections to the new drug approval mechanism existing in the country. The WHO team expressed surprise over the way new drugs are approved in the country without proper documentation on pre-clinical, clinical and toxicological studies. The WHO national regulatory appraisal team, which held a series of marathon meetings with the health ministry officials, raised thousands of questions on several issues concerning the quality of medicines and drug regulatory system in the country, sources said.

In fact, this is not the first time the WHO is pulling up the Indian health ministry for non-compliance of quality norms. Earlier this year, the WHO had asked the health ministry to either suspend the licenses of four government-owned vaccine manufacturers, Haffkine Biopharmaceuticals in Mumbai, BCG Vaccine Laboratory in Chennai, Pasteur Institute of India (PII) in Coonoor in Tamil Nadu and the Central Research Institute (CRI) at Kasauli in Himachal Pradesh or upgrade the quality of these institutes. The government had already closed down the latter three institutes.

According to sources, the WHO team also took strong objections to the government's apathetic attitude on the issue and asked why the quality standards were not improved in these institutes so that these can be reopened.