Medical Device Industry Seeks Separate Regulatory Framework from Government
Healthcare stakeholders have urged the Centre to reconsider the proposed law and create an independent regulatory structure specifically for medical devices.
NEW DELHI, Aug 12: India’s medical device industry has urged the Centre to reconsider provisions of the proposed Drugs, Medical Devices & Cosmetics Bill, 2026, arguing that medical devices require a regulatory framework separate from pharmaceuticals and cosmetics.
Industry representatives, along with hospitals and healthcare providers, have called for the creation of a dedicated regulatory authority to oversee the medical device sector.
Stakeholders said medical devices differ significantly from medicines in terms of technology, manufacturing processes, product life cycles and innovation requirements. They argued that applying a common regulatory framework could create challenges for manufacturers while potentially slowing the introduction of new technologies.
The industry has sought a system that can maintain strong patient-safety standards while supporting innovation and reducing unnecessary regulatory hurdles.
A dedicated framework could also provide greater clarity to manufacturers and investors by establishing rules specifically designed for medical devices, ranging from diagnostic equipment to advanced clinical technologies.
The demand comes as India’s medical technology sector continues to expand, with increasing adoption of sophisticated equipment across hospitals and healthcare facilities.
Industry representatives have maintained that stronger and more specialised regulation would help balance patient safety with the need to encourage domestic manufacturing, technological development and wider access to medical devices.
The proposed legislation is therefore expected to remain a key point of discussion between the government and healthcare stakeholders as India works to strengthen its medical device ecosystem.
