Healthcare and Pharmaceuticals
The pharmaceutical and healthcare sector carries the heaviest licensing load in India and the least tolerance for getting it wrong.
How we Help
We advise manufacturers, hospitals, diagnostic chains, device companies and digital health businesses. Manufacturing, loan licence and marketing arrangements under the drug legislation and the rules, including contract manufacturing and third party manufacture structures. Import and registration of drugs and devices. Clinical trial and research documentation. Price control and trade margin questions. Hospital and clinical establishment licensing, biomedical waste, radiation and fire approvals. Medical negligence defence and consumer proceedings. Advertising and the restrictions specific to therapeutic claims. Data protection in a clinical context, where consent architecture is materially harder than in commerce. Transactional work in the sector, including slump sale of manufacturing units, where the licence transfer rather than the asset transfer is what determines the timetable and is routinely underestimated in the diligence.
Manufacturing & marketing licensing
Import & device registration
Advertising & therapeutic claims
Experience
The matters below are described without identifying the client, unless the client has consented in writing to being named.
Matter lines to be added from the group's work in this area. No client name without written consent on file.
Matters are described at the level of transaction type, sector and outcome rather than identifying detail.
Further entries to be populated at launch.
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