What’s in scope

Topical Ayurvedic formulations prepared as Taila (medicated oils)—e.g., Mahanarayana Taila, Dhanwantharam Taila, Karpuradi Taila—and Malahara/lepam (balm/ointment-type) products for massage, joint/muscle comfort, skin nourishment, etc. In India these are regulated as ASU (Ayurveda, Siddha, Unani) drugs when they make therapeutic claims; non-therapeutic “beauty/wellness massage oils” can be marketed as cosmetics.

Export picture (India)

• Value & trend. India’s Ayush & herbal exports reached US$651.2 million in FY2023-24 (Apr–Mar). For Apr–Jan FY2023-24 alone, exports were US$527.08 million.
  
• What HS codes are used?
  
  • Medicinal claims (ASU drugs): HS 3004 (medicaments).
    
  • Cosmetic/wellness oils without medical claims: typically HS 3304/3307 (cosmetic/toilet preparations). (Actual 8-digit classification depends on composition/claims in the destination market.)
    
• Policy push. The Ministry of Ayush promotes exports via the AYUSH Mark certification (Standard & Premium), improving confidence and alignment with WHO-GMP expectations.
  

How quality is defined (India’s official standards)

Ayurvedic oils are codified in the Ayurvedic Pharmacopoeia of India (API) and must meet monograph limits plus GMP.

Example—Tila Taila (Sesame oil), the most common base for medicated oils, API Part-I Vol-6 requires:

• Acid value ≤ 4.0; Iodine value 103–121; Saponification value 188–195; Unsaponifiable matter ≤ 1.5%; must comply with microbial limits (App 2.4) and pesticide residue limits (App 2.5).
  

GMP & licensing (Schedule T). ASU manufacturers must be licensed by State Licensing Authorities and comply with Schedule T GMP (hygienic premises, validated processes, QC, documentation).

Shelf life (Rule 161B). Unless a longer, data-backed shelf life is approved, the default shelf life for Taila (oils) is 3 years from manufacture; Malahara (ointments/balms) 3 years. Labels must display expiry.

Optional quality marks.

• AYUSH Standard Mark: compliance with Indian ASU rules (incl. Schedule T).
  
• AYUSH Premium Mark: third-party certification aligned to WHO-GMP and enhanced contaminant limits—often used to facilitate exports.
  

Why India (and specific regions) excel

• Codified classical formulations (AFI/API) & a large licensed manufacturing base under Schedule T—this gives repeatability and testable specs.
• Oil craftsmanship clusters. Kerala/Tamil Nadu firms specialize in taila making (e.g., abhyanga/panchakarma practice drives know-how), and sesame/coconut supply chains are mature—helpful for consistent base oils that pass API limits. (API shows oil standards; cluster strength comes from long-standing ASU manufacturing under Schedule T.)
• Export-ready certifications. Growing adoption of AYUSH Premium Mark improves acceptance in regulated markets.
  

Market-entry compliance

If you sell as “medicine” (therapeutic claims):

• India: ASU drug license + Schedule T GMP + API/AFI compliance; Rule 161B expiry dating.
  
• USA: therapeutic pain-relief claims (e.g., camphor/menthol analgesic balms) place you under OTC External Analgesic Monograph (21 CFR Part 348 / FDA OTC Monograph M017). Otherwise, avoid drug claims.
  
• EU/UK: therapeutic claims → herbal medicinal routes (e.g., THR in UK/EU traditional use)—costly/long. (Most exporters avoid medicinal claims.)
  

If you sell as “cosmetic/wellness oil/balm” (no medical claims):

• USA: comply with MoCRA (facility registration, product listing, records, fragrance allergen disclosure etc.).
  
• EU: comply with Regulation (EC) 1223/2009, build a PIF/CPSR, appoint an EU Responsible Person, and notify on CPNP before sale. Note the fragrance-allergen labelling update (Reg. (EU) 2023/1545).
  

Heavy metals caution. U.S. FDA has repeatedly flagged some imported Ayurvedic products for lead/mercury; keep tight contaminant controls.

Typical specs & tests buyers should ask for

• Raw materials (base oils & botanicals): API conformance for Tila Taila etc.; include acid/iodine/saponification values, unsaponifiable matter, peroxide value (if applicable).
  
• Finished product CoA: identification tests per API/AFI monograph; microbial limits, pesticide residues, heavy metals within AYUSH/QCI or destination-market limits.
  
• GMP evidence: Schedule T certificate or AYUSH Premium Mark/WHO-GMP proof.
  
• Labelling & stability: Rule 161B shelf-life statement (3 years for taila/malahara unless extended), batch no., mfg lic no., directions, and—if cosmetic—EU/US cosmetic labelling & allergen declarations.
  
• Claims file: If shipping to the US/EU as cosmetics, remove therapeutic claims (pain relief, anti-inflammatory, etc.) unless you meet drug/THMP rules.
  

India-specific strengths

• Standards you can contract on: API monographs (e.g., Tila Taila limits) + Schedule T GMP give objective specs.
  
• Recognized export marks: AYUSH Premium Mark aligns with international GMP expectations—useful signal for customs/retailers.
  
• Scale & flexibility: Many plants can handle classical formulations and private-label cosmetic oils/balms with low MOQs under MoCRA/EU-CPNP frameworks (no medical claims).
  

Quick sourcing checklist

• Supplier holds ASU mfg licence + Schedule T GMP; share copy.
  
• CoA per batch: API tests (acid/iodine/saponification etc.), microbes, pesticides, heavy metals.
  
• Shelf life on label: ≥ 3 years (unless justified otherwise).
  
• For the US (cosmetic sale): MoCRA facility registration + product listing confirmed.
  
• For the EU/UK (cosmetic sale): Responsible Person, CPSR/PIF, CPNP/SCPN notification; fragrance allergens declared per latest rules.