India may have to abide by a series of international standards and regulatory practices in the healthcare sector, if it agrees to some proposals that are part of the ongoing India–EU Free Trade Agreement (FTA) negotiations.
For instance, EU negotiators have sought India’s commitment to adopting Global Harmonization Task Force (GHTF) norms for medical devices. The move comes at a time when India and other Asian countries are trying to formulate their own harmonised regulatory guidelines for medical devices due to divergent views on some of the GHTF standards.
So, too, with International Conference on Harmonization (ICH) guidelines for drug regulators, as India is trying to align its rules with most of the ICH standards, though not favouring a mere adoption.
“In-principle, India is working towards harmonising its standards with that of GHTF. But blind adoption of standards will only benefit global multinational medical device makers, not us,” said Rajiv Nath, co-ordinator of the Association of Indian Medical Devices Industry.
According to Nath, labeling requirements under GHTF allow companies to outsource their products from any parts of the world, without differentiating between the countries of origin. “Our labeling rules are more stringent, as we require specific disclosures with regard to the country of origin. It prevents companies from sourcing their branded products from the cheapest destinations and turn Indian products less competitive,” he said.
Similarly, EU wants Indian drug regulations to be in tune with ICH standards, though health ministry officials say a perfect alignment with ICH standards is not be possible under Indian conditions.
According to sources, EU is also advocating a harmonised drug approval process, where both parties will rely on data from clinical trials, conducted in line with ICH guidelines, for the authorisation of medicinal products for human use in their markets and refrain from requiring specific clinical trials in their territories.
Drug industry sources say strict adherence to ICH guidelines will help big pharmaceutical companies, but prove to be a barrier for the growth of smaller ones due to the cost involved in such trials.
India is also expected to become a signatory to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme for medicinal products. Jointly referred to as PIC/S, these are two international instruments between countries and pharmaceutical inspection authorities for the international development, implementation and maintenance of harmonised Good Manufacturing Practice standards and quality systems of inspectorates in the field of medicinal products.
EU also wants India to ensure its laws, procedures and implementing guidelines, related to the regulation of medicinal products, medical devices and cosmetics, to be transparent and be framed after appropriate stakeholder consultation. Such participatory approach has been suggested even in the case of price fixation of products.
