As part of streamlining the drug regulatory mechanism on par with the developed nations, regulatory experts from US FDA and Health Canada are visiting the country to impart training to the personnel and hold discussions with the Indian counterparts.

The delegation from Health Canada is coming this week for giving training to the personnel of CDSCO and holding discussions with the senior officials. Another delegation from US FDA will be in the country next week with similar agenda of training, deliberations and workshops. Besides extending tips to streamline the mechanism here, the foreign delegations would also imbibe the finer points of Indian functioning, especially on the IT-enabled front, it is learnt.

The delegations are visiting the country as follow-up to the visits by Drug Controller General of India (DCGI) and senior health ministry officials to Canada and United States sometime back for the first-hand look at the functioning there, followed by a team of CDSCO officials taking hands-on training in the two developed countries.

India and the US have identified five areas of cooperation, namely, new drugs, medical devices, clinical trials, pharmacology and IT and IT-enabled services in healthcare. US FDA will in particular help for medical devices and clinical trials, as other areas are rather functioning better in the country. Experts from the US FDA would hold workshops and training sessions in the country for Indian inspectors in the field of inspecting and auditing medical devices, besides training them to monitor clinical trials better, sources said.

The World Health Organisation (WHO), that had found some lacunae in the Indian regulatory system, had facilitated the tie-up with the two developed countries to modernize and improve the mechanism here. It is also funded by the world agency, which was apprehensive of huge impacts at the global scene, if Indian system did not improve drastically.

Health Canada will also help documenting the dossiers, clinical trials, approvals and other records in the CDSCO with a view to fine-tune the Indian system. On the other hand, Canadian authorities are keen to gain from e-governance programmes being launched in the country.