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Commerce ministry seeks inputs on pharma trade related issues being faced with Japan
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Shardul Nautiyal, Mumbai
December 02 , 2025
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The Department of Commerce (DoC), under the Union Commerce Ministry, has sought inputs from the industry on specific issues being faced in pharma trade with Japan. These issues include those related to Technical Barriers to Trade (TBT), Rules of Origin (ROO), Tariff and Non-Tariff Barriers (NTBs).
Industry inputs have been sought to prepare a detailed submission for discussion during the forthcoming Committee Meeting under the India–Japan Comprehensive Economic Partnership Agreement (CEPA) at the Commerce Secretary level to be held soon.
Indian pharma exporters face numerous non-tariff barriers, particularly in the form of Japan's stringent technical, sanitary, and phytosanitary (SPS) standards. Implementing and agreeing upon ROO for goods traded under the Comprehensive Economic Partnership Agreement (CEPA) is another contentious area.
India is pushing for a review of the 2011 CEPA to address the perceived imbalance and the NTBs faced by Indian exporters.
Japan is known for its advanced healthcare technology and pharmaceutical industry, whereas India has a significant pharmaceutical manufacturing sector known for its high quality and cost-effective generic drugs. Promoting trade in these sectors could lead to increased collaboration in research and development, technology transfer, and investment opportunities. It could also help address healthcare challenges in both countries and contribute to the development of innovative medical solutions.
There are disagreements over quality control and certification standards, such as India's pharmaceutical industry's request for mutual recognition of standards with Japan, and Japan's insistence on its own stringent testing measures.
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has also highlighted several market access challenges faced by the Indian pharmaceutical industry in Japan and has raised these issues with the concerned authorities through the Export Products (EP) (Pharma) Division of the DoC. The Government of India has been taking up these matters with the Japanese authorities through various bilateral forums.
The EP (Pharma) Division of the DoC in India handles the export promotion for pharmaceuticals. This division is responsible for export promotion activities and administrative matters related to the Pharmexcil. It also works with industry stakeholders to identify and address challenges, such as non-tariff barriers, to boost pharmaceutical exports.
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