In a major boost for India’s medical device sector, the India-UK Free Trade Agreement (FTA) has introduced a mutual recognition framework that will streamline the entry of Indian-certified medical devices into the British market, a senior government official confirmed on Tuesday.
The pact is designed to grant easier access for Indian manufacturers by recognising certifications from domestic regulatory bodies such as the Central Drugs Standard Control Organisation (CDSCO) and the Indian Certification of Medical Devices (ICMED). This strategic move is expected to position Indian products more competitively against global players from countries like China, Brazil, and Vietnam, who do not enjoy similar preferential terms and continue to face standard tariffs.
One of the key highlights of the agreement is the elimination of tariffs — currently ranging between 2% and 6% — on exports of Indian surgical and diagnostic equipment to the UK. This zero-duty access is anticipated to significantly improve cost competitiveness for Indian exporters.
The UK medical devices market, valued at $32 billion in 2024, is projected to more than double to $69 billion by 2035, growing at a compound annual rate of 7.19%. With this growth trajectory, the market presents a substantial opportunity for Indian manufacturers looking to expand globally.
Beyond tariff relief, the pact also lays the groundwork for enhanced regulatory cooperation. A bilateral framework between India’s CDSCO and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is under consideration, potentially culminating in a full-fledged Mutual Recognition Agreement (MRA). This would allow for joint inspections, technical harmonisation, data sharing, and regulator training programmes — measures that would deepen trust and facilitate smoother regulatory processes.
The agreement also addresses concerns around trade circumvention through robust Rules of Origin (RoO) provisions. These ensure that only goods genuinely produced or significantly processed in either India or the UK qualify for duty benefits, thereby safeguarding against third-country routing. This will be supported through digital certification systems and close customs oversight.
India has reiterated its commitment to a balanced and equitable trade partnership, with ongoing efforts to align regulatory standards and promote mutual recognition — a move poised to unlock long-term growth in the life sciences and healthcare exports sector.
(With inputs from PTI)