Day: November 17, 2025

New Delhi, 17 November 2025: The Association of Indian Medical Device Industry (AiMeD) has welcomed the Government of India’s landmark decision to withdraw multiple Quality Control Orders (QCOs) imposed in recent years on essential raw materials across polymer, plastic, textile, and chemical value chains. The reversals, notified in the Gazette on 12 November 2025, cover critical inputs such as ABS, polypropylene, polyethylene, polyester fibres and other raw materials widely used by medical device manufacturers.

This policy correction follows extensive submissions by AiMeD and other industry stakeholders to the Rajiv Gauba Committee at NITI Aayog and the RIS. Industry had consistently highlighted that mandatory BIS standards for raw materials were functioning as unintended import restrictions. India does not produce many of the high‑grade polymers required for precision moulding and steel grades for making high‑performance components, and export‑quality medical devices. As a result, QCOs were forcing manufacturers to rely on lower‑grade domestic substitutes or face long delays and higher costs in accessing globally compliant inputs.

Welcoming the decision, Mr. Rajiv Nath, Forum Coordinator, AiMeD, said:
“It’s a good decision – as the BIS licence was being used as an import restriction on plastics and steel raw materials. Technical regulations should be applied only to finished consumer goods, including medical devices, as a Make in India enabler and to protect consumers’ interests. But by not allowing us to import the right grades and quality of raw materials from Switzerland or Japan – and forcing us to buy low‑grade, low‑performance quality Indian materials that did not meet the performance needs of discerning manufacturers – we were not becoming globally competitive. We had kept our case to the Rajiv Gauba Committee at NITI Aayog and are glad the Government listened empathetically and acted on our concerns.”

The withdrawn QCOs covered a wide range of polymer and chemical intermediates that form the backbone of syringes, IV sets, catheters, diagnostic consumables, packaging materials, and other medical devices. India’s domestic supply base does not yet manufacture many of these materials at global specifications, making access to imported grades essential for ensuring product safety, performance, and export readiness.

AiMeD believes this step will ease input shortages, reduce compliance delays, lower manufacturing uncertainty, and improve India’s competitiveness in global markets. It also reflects a welcome shift toward a pragmatic regulatory approach—evaluating risk at the level of finished products rather than imposing blanket controls on upstream raw materials.

Next Step: Removal of NOCs

AiMeD has urged the Government to now advance the next reform prioritized in its submissions to the Gauba Committee—the removal of No Objection Certificate (NOC) requirements imposed by various agencies for the import of raw materials, intermediates, and components or reimporting returned export shipments and even at various stages of putting up a green field manufacturing project. These NOCs are usually arbitrary and not backed by legislation or Executive Orders and often duplicate regulatory functions, create procedural delays, and act as non‑tariff barriers that not only weaken the Ease of Doing Business framework but also add to cost of doing business and make manufacturing less competitive or appealing option.

A streamlined system focused on regulating finished medical devices—combined with post‑market surveillance and internationally harmonised standards—will further strengthen India’s Make in India ambitions and support the growth of the domestic MedTech ecosystem.

AiMeD’s Commitment

AiMeD will continue working closely with the Government, BIS, and relevant Ministries to advance rational, risk‑based regulations that safeguard patient safety while fostering innovation, affordability, and global competitiveness.

About AiMeD

The Association of Indian Medical Device Industry (AiMeD) is the umbrella body representing over 1,800 manufacturers of medical devices across India. AiMeD works closely with government and stakeholders to strengthen India’s MedTech ecosystem, promote self‑reliance, ensure patient safety, and build global competitiveness. The association advocates for supportive policies, quality standards, and capacity building to make India not only self‑sufficient but also a global hub for affordable and high‑quality medical devices.