Composition & Ingredients

Define the core active ingredients and the foundational knowledge source for your formulation.

Source of Formulation Knowledge

Regulatory Engine Context

This field determines the regulatory pathway for "Source of Formulation Knowledge". The engine analyzes this to detect compliance triggers.

Classical Text (e.g., Charaka Samhita, Sushruta Samhita)

Exempt from new safety/efficacy clinical data requirements under Rule 158B(I)(A).

Proprietary Mix (Patent & Proprietary - P&P)

Standard patent and proprietary medicine regulations apply under Section 3(h) & Rule 158B(II).

Tribal / Traditional Community Knowledge

Triggers mandatory Benefit Sharing agreements with indigenous communities and BMCs.

Ayurvedic Pharmacopoeia of India (API) / AFI Standards

Recognized official pharmacopoeial monograph under Second Schedule of Drugs & Cosmetics Act.

Siddha or Unani Classical Treatises

Authoritative texts listed in the First Schedule under Siddha or Unani Tibb systems.

Novel In-House R&D / Innovative Formulation

Completely novel botanical combination; potentially patentable if non-obvious and not barred by Section 3(p)/3(e).

Uncodified Ethnobotanical Field Collections (PBR)

Documented in People's Biodiversity Registers; mandatory Access & Benefit Sharing (ABS) agreement.