The medical devices lobby has written to the Department of Pharmaceuticals (DoP) opposing the import of medical devices at zero duty under the EU-FTA. The trade talks are underway.
At the moment, India is 70 per cent import-dependent, and Germany and the Netherlands are among the top five countries from where we import. The main reason for the opposition from the local industry is their claim that the EU regulatory system permits organisations to label themselves as legal manufacturers even if they are not making the product themselves, which has led to ‘pseudo manufacturing’ in the EU, as the country of origin is not listed on the labelling of med-devices in the EU and UK (unlike in the US and India).
In a letter dated September 21 to Arunish Chawla, pharma secretary, and Nitin Yadav, joint secretary, Department of Commerce (medical devices), and others, Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD), said that they ‘strongly’ oppose the zero-duty import proposal under the EU-India FTA, for which talks are underway.
AiMeD is an umbrella organisation representing domestic medical devices makers.
From countries like Germany and the Netherlands, India’s imports of medical devices have grown over the years. From Rs 4,742 crore in FY20, imports from Germany grew to Rs 7,490 crore in FY24, and from Rs 2,329 crore in FY20, the imports grew to Rs 3,815 crore in FY24 from the Netherlands.
Nath claimed that the regulatory system for medical devices in the EU allows organisations to label themselves as ‘legal manufacturer’ even if they are not making the product themselves.
“This was done to allow EU regulators to make the market authorised holder responsible and accountable from the patient safety perspective, but this facility has been abused and led to pseudo manufacturing thriving in the EU, as the country of origin is not insisted upon on the labelling of medical devices in Europe and the UK, unlike the case in the US and India, which seek labelling of the country of origin on the unit of sale,” he mentioned in the letter. Therefore, legal manufacturers should be kept out of the FTA, AiMeD claimed.
“We have been given assurance in the past for the UK-India FTA that ‘legal manufacturer’-labelled packages will not enjoy zero-duty FTA benefits if the manufacturer or exporter is not an actual manufacturer and cannot prove that they assemble and manufacture the medical device in the UK with at least 40 per cent value addition,” the letter said.
The medical devices lobby here felt that medical devices made in China and Taiwan would end up landing in India through this loophole under the EU-India FTA.
Nath further claimed that India needs to focus on a mutual recognition agreement of regulatory approval or QMS certification like Indian Certification for Medical Devices (ICMED). The focus has to be on fast-tracking the CE certification process for Indian exporters to enter the EU medical devices market. If not, AiMeD said that India needs to implement a policy of inspection of EU factories and verification of compliance with Indian Medical Device Regulations in the EU by Indian regulators.
“We recommend factory inspection and verification by Bureau of Indian Standards (BIS) and CDSCO inspectors for the country of origin, with value addition of 35 per cent and change of sub-tariff headings as both mandatory minimal conditions for protecting Indian manufacturers,” the letter said.
First Published: Sep 23 2024 | 4:13 PM IST
