India's drug regulator has officially turned its attention to the lab of the future. The CDSCO — the Central Drugs Standard Control Organisation — has formed an expert panel to figure out how AI in drug discovery should be evaluated, approved and regulated in India. DCGI Rajeev Raghuvanshi announced the move on Friday at the 8th CII Pharma and Lifesciences Summit in New Delhi.
01.What the committee will actually do
According to Raghuvanshi, the panel includes AI experts, and its discussions will cover the three questions every regulator is currently wrestling with: how do you evaluate an AI system used to discover medicines, how do you approve its outputs, and how do you regulate the whole process?
"Regulation of AI in healthcare is a subject that is being discussed by all agencies globally," he said — which is a polite way of admitting nobody has cracked it yet, not the US FDA, not Europe, and not India. No timeline or terms of reference were shared, so this is early days.
02.This didn't come out of nowhere
The announcement lands exactly a month after CDSCO issued a guidance document on how software-based medical devices — including AI-enabled products — will be regulated under the Medical Devices Rules, 2017. The logic there is simple: any software intended by its manufacturer for a medical purpose counts as a medical device, full stop. That guidance covers products already in the market. This new panel goes a step earlier in the pipeline — to the discovery of new molecules themselves.
And it's not happening in isolation. Indian healthtech has been quietly earning global credibility — Qure.ai recently became the first Indian company to win Class IIB CE certification for its Aira chest X-ray foundation model, which we covered earlier, and AIIMS has built AI that reads mammograms. When the outputs start influencing diagnosis and drug development, regulators have no choice but to get involved.
03.The digital overhaul running in parallel
Raghuvanshi also gave an update on the DDRS — the Drugs and Diagnostics Regulatory System, a unified single-window digital platform meant to overhaul pharmaceutical and medical device regulation in India. Twelve companies have bid to build it, technical presentations are done, and financial viability will be checked within the next seven to ten days.
The ambition is a single real-time architecture connecting central and state regulators, laboratories and allied agencies — covering everything from registration and clinical trial approvals to import-export licensing and supply-chain traceability. He expects the industry to see plenty of AI interventions, simplified processes and data analytics in the regulator's own internal work, improving ease of doing business.
04.Why pharma companies should care
Every major drugmaker is already experimenting with AI-driven discovery — molecule screening, target identification, predicting which compounds will survive trials. In a market like India, where cost pressure is brutal and the generics business runs on thin margins, AI that shortens discovery timelines is worth a fortune.
The catch: if your discovery pipeline relies on AI, and the regulator doesn't know how to assess that, approvals could stall — or worse, shortcuts could get through. A clear framework, even a slow one, is better than a vacuum. That's the gap this panel is meant to fill.
05.New-age therapies are moving too
One more detail from the summit worth noting: India's third CAR-T therapy — a personalised cancer treatment where a patient's own immune cells are engineered to fight tumours — is in the final stages of approval. An indigenous gene therapy will soon begin phase-1 trials. These are exactly the kinds of complex, data-heavy treatments where AI-assisted development and regulatory oversight will have to learn to work together.
We've covered this space before — Anthropic's Secret Biology Lab: Claude Is Moving Into Drug Science and Anthropic's Life Sciences Program Opens Claude's Guardrails for Bio Research.
Key Takeaways
- CDSCO has formed an expert committee with AI experts to regulate AI in drug discovery
- No timeline or terms of reference have been announced yet
- AI-enabled software medical devices are already regulated under MDR 2017 following last month's guidance
- The DDRS digital regulatory platform is moving forward — financial viability checks due in 7-10 days
- India's third CAR-T therapy is near approval; indigenous gene therapy enters phase-1 soon
Frequently Asked Questions
What has CDSCO done about AI in drug discovery?
India's drug regulator CDSCO has created an expert committee to work out how AI in drug discovery should be evaluated and regulated.
Who announced the panel and where?
DCGI Rajeev Raghuvanshi announced it at the 8th CII Pharma and Lifesciences Summit in New Delhi.
How does this fit with CDSCO's other AI moves?
It comes a month after CDSCO's guidance that brought AI-enabled software medical devices under the Medical Devices Rules, 2017.
What This Means for You
If you're a pharmacy or biotech student, this is a careers heads-up: "AI + regulatory affairs" is about to become one of the most sought-after profiles in Indian pharma. If you work in healthtech or pharma, expect documentation and validation requirements around AI tools to tighten over the next couple of years — building those habits now will save you real pain later. And if you're a founder eyeing the drug-discovery space, this panel is the signal that India wants that innovation to happen here, just with a rulebook attached.
Building an AI-first career or business in a regulated field? Our GPT-6 Astra — Zero to Hero Guide covers the practical foundations — prompting, AI agents, cost optimization, business ideas and using AI safely — the same skills that make you useful when industries like pharma go AI-native.