A regulator-recognised foundation: CDSCO Class B and a state manufacturing licence

Trust in a standard depends on trust in the instruments behind it. The Alliance's anchor technology — PinnacleAI GPT-OS®, the software-as-a-medical-device behind AbilityScore® — has been independently classified by India's Central Drugs Standard Control Organisation (CDSCO) as Class B software-as-a-medical-device (file MD/classification/2025/150), and the Anchor holds a state MD-5 manufacturing licence granted by the Drugs Control Administration of Telangana on 21 April 2026, following a positive notified-body recommendation.

Why this matters for the field

Regulatory classification is not a marketing badge; it is an external authority independently judging that a technology is what it claims to be, and holding it to a quality-management standard (the Anchor is certified to ISO 13485:2016 and ISO/IEC 27001:2022). For institutions and employers weighing whether to adopt the Alliance's tools, it means the measurement instrument has already cleared a bar set by someone other than its maker.

It also matters for where the field can go. A regulator-recognised foundation is the starting point for international pathways — and for a standard that India can carry outward rather than only adopt from elsewhere.

A reminder on language: these are real classifications and licences as of May 2026; patent references elsewhere on this site are to international (PCT) applications, not granted patents; and IRWFA complements the RCI and statutory regulators rather than replacing them.

Published by the IRWFA Secretariat. Operational figures are forward-facing as of May 2026; patent references are to international (PCT) applications, not granted patents; “largest / first” is stated to our knowledge as of May 2026. IRWFA complements the Rehabilitation Council of India and does not supplant it; statutory recognitions are in process.