The Pharmaceutical Staff Plan (DOP) could include subsidies for small and medium -sized enterprises (SME) to reduce the high cost of compliance, agreements on mutual recognition with US food and drug management (US FDA) to be more easily accepted by documents recognized with reviews and two people and two people and two people who are familiar with And two people and two people and two human reviews and two people and two human reviews and two people and two human reviews and two people and two human reviews and two human reviews.
Indian exporters are currently facing significant business barriers, including high FDA registration costs. They are obliged to hire agents based in the US and their Indian clinical data are often not accepted, with the US insisting in local studies. All these factors cause exports to slow and expensive.
The DOP export Council for medical devices (EPCMD) and industry associations have recently submitted proposals to the government, which aims to shorten the average time approval by 30% and increase export value to the US by 25% within three years.
According to the first of the two cited persons, a high level of meetings of officials and stakeholders at a high level introduced a comprehensive analysis of barriers to market access and export trends for the Indian sector of medical devices.
“The proposed solutions, including targeted subsidies for small and medium -sized enterprises, agreements on mutual recognition with FDA and improved regulatory infrastructure are aimed at strengthening global competitiveness of the Indian medical industry. These measures are designed to reduce compliance costs, streamline exports. “The government was looking for inputs from industrial associations to review the situation after several reports that store tariffs.”
Certainly, this is a recommendation of industry and the final decision on the healthcare sector has to make the government.
The Indian industry industry is currently appreciated by approximately $ 12 billion and by 2030 it is expected to increase $ 50 billion by 2030.
“This initiative directly addresses the excessive context of the country in the area of imports of medical devices. By supporting domestic production, the government plans to reduce vulnerability to the supply chain disruption, lower health care costs for its citizens and in accordance with” Atmanirbhar Bharat “(independent India).”
DOP spokesperson questions remained unanswered until the press time.
While the export of Indian medical devices to the US has increased between May and August 2025, the trade deficit continues to grow with imports from the American overtaking exports. During May to August, the Indian healthcare facility was exported to the US by 9.3% to $ 279.58 million, while imports increased by 15.2% to $ 646.20 million, resulting in $ 366.62 million.
This imbalance is powered by a number of significant obstacles to which Indian companies face when trying to enter the American market. The primary obstacle is the high cost of obtaining products approved by the US FDA. According to government documents reviewed by Mint, these costs can range from $ 30,000 per basic equipment such as catheter, thermometer, etc. For more than $ 483,560 for each complex device such as dialysis, X -ray, MRI and ultrasound machines. In addition to direct costs, Indian exporters are also obliged to have a local US agent who increases their operating expenses and complexity.
The Indian industry industry welcomed this step.
Himanshu Baid, CEO of PolyMedicure LTD, a manufacturer of medical devices, said that a plan that is preparing for an Indian medical facility signals a shift towards building long -term competitiveness than short -term compliance.
“Strengthening test infrastructure and accreditation processes will allow the industry to focus on innovation, scale and global quality scale. By seizing small and medium -sized enterprises through targeted support and harmonized standards, it will catalyze further growth phase where companies will not only produce on scale.”
“These reforms can transform India from a cost -effective manufacturing goal into knowledge focused on knowledge focused on knowledge, powered by stronger clinical abilities, research cooperation and more enabling a control framework,” he added.
The meeting of the last month also focused on the confused problem of high tariffs stored in Indian goods, which can be up to 50%on medical devices. This is significantly higher than 30% for Chinese products and 15% for people from the European Union, which significantly disadvantages to Indian companies.
The instant plan in the next 12 months includes targeted subsidies for small and medium -sized enterprises to help them with high costs such as ISO 13485 certification and fees for the FDA consultant. In addition, one online portal will be created to simplify export papers and customs clearance. There will also be an “export facilitation table” with representatives of the Ministry of Pharmaceuticals, the Ministry of Commerce and Industrial Associations that would lead the Company FDA.
In the medium term (6-24 months), the plan revolves around monitoring agreements on mutual recognition with regulatory bodies to speed up the review period and expand the number of accredited laboratories in India to reduce the need for expensive overseas testing.
Long -term vision involves the creation of Indian regulations to comply with global standards, to use diplomatic efforts to solve discriminatory tariffs, and build a stronger research and development ecosystem (R&D) to produce higher value and more innovative products.
Rajiv NATH, a forum coordinator, the Association of Indian Medical Manufacturers (aimed), said the Indian export of medical devices exceeded $ 4 billion in the years 2024-25 compared to more than $ 8 billion in imports, adding that Indian exports of medical devices can only grow in mutual trade.
“Although we maintain low, strict regulatory barriers to the US and the EU cause the market to be very expensive and slow. India must match domestic regulations for medical devices with Global ISO standards, to persecute MRA (mutual recognition of agreements), as well by fusion ascarities) with concorditation (Ascala (Ascala (Ascoma) (Ascomca) Ascala) acceptance and requires a fairer approach to these markets before the decrease in tariffs to protect industry and export, ”Nath said.
(Tagstotranslate) exports of medical devices
