Medical devices are NOT pharma products. And we need to start thinking differently. 🙃
The current debate around the Draft Drugs, Medical Devices and Cosmetics Bill, 2026 is important. The concerns being raised by the medical-device industry about a pharma-centric approach, criminal penalties and the impact on innovation deserve serious attention.
But I feel we are missing another important part of the discussion.
Who is actually shaping the medical-device regulatory thinking?
Medical devices are engineering products. Their lifecycle involves design controls, risk management, verification & validation, manufacturing, quality systems and post-market surveillance. It cannot be approached with a purely pharmaceutical mindset.
We also talk about Notified Bodies and certification. But certification alone cannot create a quality culture.
A certificate is not quality. Quality is a culture.
And that culture has to start much earlier — in our colleges.
Biomedical engineering students should be exposed to medical-device quality, ISO 13485, risk management, design controls, regulatory affairs, validation, QA/QC and post-market surveillance as part of their education.
Because the people sitting in our QA, QC, R&D, manufacturing and regulatory teams tomorrow are the students sitting in classrooms today.
So yes, let us debate the Bill.
But let us not spend all our energy only on the Bill.
India doesn't just need better medical-device regulations.
India needs better medical-device quality thinking.
That is where the real global competitiveness will come from.