Perturbed by the lacunae in the Indian drug regulatory system which could jeopardise the global supply of vaccines, the World Health Organisation has facilitated a tie-up between CDSCO and Health Canada to modernise and improve the regulatory mechanism here.

Under the collaboration, which would run till the end of next year, a series of interactions between the officials on both the sides and workshops would be held and know-how on administration would be imparted. Fully-funded by WHO, the partnership would also cover extending assistance to improve the functioning of public sector vaccine manufacturers.

DCGI Dr Surinder Singh, who undertook a week-long visit to Canada to get a first hand view of the working there recently and chalk out the details of the tie-up, told Pharmabiz that India would try to adopt the better aspects of Canadian authority to fine-tune the CDSCO.

WHO decided to broker the collaboration after it found many drawbacks in the Indian system during its detailed assessment recently. The UN agency was also seriously concerned about the matter as India was supplying vaccines to 150 countries, accounting for almost 60 per cent of global supply. Any lapse in the Indian system could jeopardise the world situation and the collaboration would thus indirectly ensure smooth supply of vaccine ahead.

Health Canada will also help documenting the dossiers, clinical trials, approvals and other records in the CDSCO, which came in for criticism by the WHO, while on its part, Canadian authorities would be looking to gain from e-governance programmes being launched in the country, which is known for its strength in information technology.

Apart from arranging the visit of DCGI, some senior officials of the health ministry including joint secretary Devashish Pandey were also taken to the WHO headquarters for training.

It may be noted that the WHO appraisal team expressed surprise over the way new drugs are approved in the country without proper documentation on pre-clinical, clinical and toxicological studies. WHO had earlier prompted the government to suspend the licences of four government-owned vaccine manufacturing units. This has also compelled WHO to facilitate the collaboration with a view to stabilise the global supply of vaccines.