New Delhi, November 19, 2025 – In a landmark move welcomed across industries, the Government of India has officially withdrawn multiple Quality Control Orders (QCOs) on key raw materials critical to the medical devices sector. This policy shift, notified in the Gazette on November 12, 2025, is expected to significantly ease regulatory bottlenecks and boost manufacturing agility across the country.
The medical devices industry, which heavily depends on imported raw materials such as ABS, polypropylene, polyethylene, polyester fibres, and various polymer and chemical intermediates, sees this as a much-needed reform. These materials are fundamental to manufacturing products like syringes, IV sets, catheters, diagnostic consumables, packaging, and other medical components.
A WELCOME RELIEF FOR INDIAN MANUFACTURERS
The Association of Indian Medical Device Industry (AiMeD) has voiced strong support for the government’s decision. In a statement, AiMeD noted that the removal of QCOs addresses long-standing concerns regarding access to imported materials that meet global quality benchmarks. Given India’s limited domestic capacity to manufacture these materials at internationally acceptable specifications, the QCO withdrawal is seen as an enabler for both domestic production and global competitiveness.
AiMeD has also called on the government to use this momentum to advance further reforms. Among their top recommendations is the elimination of No Objection Certificate (NOC) requirements imposed by various agencies for the import of raw materials, intermediates, and components. They emphasized that these restrictions often delay export shipments and create unnecessary hurdles in greenfield manufacturing projects.
IMPLICATIONS FOR THE MEDICAL DEVICE ECOSYSTEM
1. Smoother Supply Chain Operations
Manufacturers can now import critical raw materials without the prior burden of QCO compliance. This will streamline procurement, reduce administrative delays, and lower compliance costs.
2. Access to Global-Quality Materials
The relaxation facilitates easier sourcing of high-grade inputs that meet international performance and safety standards particularly important for export-oriented manufacturers.
3. Enhanced Export Readiness
With fewer import restrictions and certification bottlenecks, Indian manufacturers will be better positioned to fulfill international orders promptly and compete in global markets.
4. Encouragement for Manufacturing Expansion
By simplifying import regulations, the decision opens doors for new investments and project expansions, especially in greenfield sites aiming to scale up production capacity.
LOOKING AHEAD: A PUSH TOWARD BROADER REFORMS
The medical devices industry has interpreted this move as a strong signal of the government’s intent to foster ease of doing business in India’s regulated sectors. Industry leaders now look forward to additional reforms that reduce bureaucratic red tape and encourage innovation, scalability, and export competitiveness.
As the country aims to become a global manufacturing hub under the Make in India initiative, the rollback of QCOs marks a decisive step toward unlocking the full potential of India’s medical device manufacturing ecosystem.