Q.01

How do I export Ayurvedic medicines from India?

To export Ayurvedic medicines from India, you need three things in place. First, a State Ayurveda/Siddha/Unani (ASU) manufacturing licence and a Schedule T GMP certificate. Second, export packs labelled under rule 161A of the Drugs Rules, 1945. Third, the shipment must clear India's foreign-trade rules: an Importer-Exporter Code (IEC) and the DGFT export policy, which allows formulations freely but limits listed medicinal plants. The importing country's own registration rules come on top of this.

1. Licence and GMP (Drugs Rules, 1945, Part XVI)

  • Who licenses you: each State Government appoints the ASU licensing authorities [1]. Every manufacturing site needs its own licence [1].
  • Application (rule 153): Form 24D on the e-AUSHADHI portal. The fee is Rs 2,000 for classical drugs under section 3(a). For patent or proprietary medicines it is Rs 3,000 for the first ten products and Rs 2,000 for each product after that [1].
  • Licence (rule 154): issued online in Form 25D, within two months of the application or of your answers to any shortcomings. The State consults an approved ASU expert before granting it [2].
  • Loan licence: if you have no plant of your own, a loan licence lets you use a Form 25D licensee's facilities [2].
  • GMP certificate: apply in Form 24E-1 (rule 153B), fee Rs 5,000, for premises that meet Schedule T [2]. The certificate (Form 26E-I) is issued together with the Form 25D licence [3] and is valid for five years [4]. Schedule T covers authentic raw materials, the prescribed process, quality control and a documented manual [5].
  • Other licence conditions:
    • At least one full-time technical person qualified in Ayurveda, Siddha or Unani [3].
    • Raw materials must be identified and tested [6].
    • Naming limits: no prefixes or suffixes on classical drug names, and classical names may not be used for proprietary medicines [3].
    • Safety and effectiveness evidence depends on the product category. For example, a classical formulation used for its textual indication needs published literature only. A new indication needs proof of effectiveness [7].

2. Export labelling (rule 161A)

  • Labels "may be adapted" to the importing country's law. However, the label "shall" show, on the container and every outer covering [8][9]:
    • the drug name;
    • the manufacturer's name, address and licence number;
    • the batch number;
    • the manufacture date and a "Best for use before" date;
    • the main ingredients, if the importing country requires them;
    • the words "for EXPORT".
  • Some buyers want no manufacturer name on the label. This is allowed only for products not classified under the First Schedule or Schedule E(1): the label then carries a code number approved by the licensing authority [9].
  • The expiry date must also be shown conspicuously (rule 161B) [9].

3. Certificates importers usually ask for

  • Free Sale Certificate and Non-Conviction Certificate (rule 158C): on your request, the State Drug Controller "shall" issue these within fifteen days [10]. You apply online through e-AUSHADHI [6].
    • The Free Sale Certificate is Form 26E2-I for licence holders and Form 26E2-II for loan licensees. It can also be issued in the importing country's format [10][11].
    • The Non-Conviction Certificate is Form 26E3, covers the last three years and is valid for one year [12].
  • COPP (Certificate of Pharmaceutical Product) under the WHO GMP Certification Scheme: CDSCO grants these after inspections it carries out with the Ministry of AYUSH and the State AYUSH authority [13].
    • In CDSCO's 2018 holder list, the COPPs were valid three years, or less if the manufacturing licence expired sooner. Several products were marked "(Export only)" [14].
    • Since 15.08.2025, WHO-GMP (COPP) applications can only be filed through the ONDLS portal; paper files are not accepted [15]. Your licence and product data must first be approved on ONDLS by the State regulator [16]. These circulars refer to WHO-GMP COPP in general, not specifically to Ayurvedic products.

4. Foreign-trade and customs rules (DGFT)

  • IEC: "No export or import of goods shall be made by any person without obtaining an IEC" (FTP 2023, para 2.05). The IEC must be updated every year between April and June.
  • Shipping documents: bill of lading or airway bill, commercial invoice cum packing list, and shipping bill (para 2.06).
  • DGFT export policy, ITC (HS) 2021 Schedule 2 (DGFT):
    • "Derivatives, extracts and formulations" (listed 3003/3004 codes) are Free, subject to the Wild Life (Protection) Act, 1972 and CITES.
    • Plants and plant parts of wild origin of the 29 listed species are Prohibited. Examples are Sarpagandha (Rauvolfia serpentina), Kutki (Picrorhiza kurrooa), Aconitum, Nardostachys and Swertia chirata.
    • The schedule notes that "formulation" may include products containing extracts of those plants. Where a formulation contains CITES species, a CITES export permit is required and those exports may leave only through the named ports.

I did not check what the importing country requires (its own product registration or notification, for example). That depends on the destination.

Approach: I used CDSCO's September 2024 compilation of the Drugs Rules, 1945, CDSCO's Ayurvedic COPP holder lists and circulars, and DGFT's Foreign Trade Policy 2023 and ITC (HS) Schedule 2. I couldn't open the Ministry of Ayush and PIB pages on the planned Ayush Export Promotion Council, so it isn't covered.

If you tell me the destination market (EU, US, GCC, Russia and so on), I can check its import rules for Ayurvedic products.

Q.02

When do I need a COPP?

Short answer: In the Indian sources I checked, a COPP is not a legal precondition for exporting Ayurvedic medicines. CDSCO issues it under the WHO Certification Scheme "for use in international commerce only" [17]. So you need one when the importing country's regulator or your buyer asks for it. That is usually when the product is being registered in the destination market.

Where it sits in the Indian rules

  • For an Ayurvedic exporter, the Drugs Rules set the State Form 25D licence, Schedule T GMP and the rule 161A export label as conditions. Free Sale and Non-Conviction Certificates are issued on request. I found no rule in the Drugs Rules, 1945 compilation that makes a COPP a condition of export.
  • For Ayurvedic manufacturers, CDSCO inspects jointly with Ministry of AYUSH and State AYUSH staff before it grants a COPP. It also publishes the list of COPP holders [13].
  • A COPP covers named products, not the whole site. Each CDSCO Ayurvedic list gives each company's products with their own grant dates [18].

When you have to apply (CDSCO WHO-GMP circular of 3 March 2020) This circular is addressed to all State Drugs Controllers about WHO-GMP COPPs in general, not only Ayurvedic ones.

  • The three cases: you apply for a first grant, a revalidation, or to add a product [19].
  • First-time applicants: a joint inspection by CDSCO zonal or sub-zonal officers and the State Licensing Authority is planned after your documents are reviewed. The COPP is issued once any deficiencies found are fixed [20].
  • Adding a product: if your site was jointly inspected within the last two years and found compliant with WHO TRS guidelines, the COPP "shall be issued" once you provide the complete product data (Annexure B) [20].
  • What you file: the application, a site master file (WHO TRS 961, Annex 14), your manufacturing licence, approved and applied-for product lists, SOPs and STPs, three-batch stability data, equipment and staff lists, the layout plan, and process validation for three batches of each product [19][20].
  • Timelines: CDSCO sends its recommendation to the State within 21 working days if no joint inspection is needed, or 28 if one is. The COPP is then issued within 5 days [20].

Validity and renewal

  • In CDSCO's September 2017 Ayurvedic list, COPPs were valid for two years from issue, or until the manufacturing licence expired if that came sooner [18]. The 2018 list I cited last time showed three years. Plan for revalidation before expiry, because importers usually want a COPP that is still valid.

How to file now

  • Since 15.08.2025, WHO-GMP (COPP) applications must go through the ONDLS portal, and physical files are not accepted [15].
  • Before you can apply, your licence and product data must be approved on ONDLS by the State regulator. That means registering the site, the technical staff and the licensed products first [16].

Approach: I searched CDSCO's circular archive, its Ayurvedic COPP holder lists and the 2024 compilation of the Drugs Rules, 1945. Whether a given destination needs a COPP is set by that country's registration rules, which these Indian sources do not cover.

If you tell me the target market, I can check whether its registration rules ask for a COPP.

Q.03

What changes when exporting to the United States?

To the FDA there is no such thing as an "Ayurvedic medicine." Your India-side steps still apply: the Form 25D licence, Schedule T GMP and the rule 161A export label. But the US treats each product as a drug, a dietary supplement or a cosmetic depending on its claims, and that choice decides everything else. Most Ayurvedic exporters use the dietary supplement route. That route has no pre-approval, but it rules out disease claims and brings facility registration, US-style GMP, heavy-metal scrutiny and fixed label content. None of the US provisions I read asks for a COPP.

1. Claims decide what the product is

  • Under the FD&C Act, a "drug" includes articles intended to diagnose, cure, mitigate, treat or prevent disease [21].
  • A "dietary supplement" is a product meant to supplement the diet that contains, among other things, "an herb or other botanical" and is labelled as a dietary supplement [21].
  • A new drug needs an FDA approval before it can be sold [22].
  • Indications copied from classical texts make the product an unapproved drug. FDA warned a US seller of Kerala Ayurvedic products (Dasamoolarishtam, Maha Tiktaka Ghrutham, Triphala, Ashwagandha and others) because its website claims made them "unapproved new drugs" [23].
  • Import Alert 66-41 (unapproved new drugs) lets FDA detain shipments at the border without examining them. It lists Indian firms, for example all Kapiva Herbals products, because of website claims such as "effective ayurvedic medicine to reduce diarrhea" [22]. Products sold as dietary supplements or cosmetics can be added to it if their claims make them drugs [22].

2. Dietary supplement route: what you must do

  • Facility registration: a foreign facility must register and "shall include" the name of its US agent. Renewal falls between 1 October and 31 December of each even-numbered year [24]. That means the window is open now, in 2026.
  • Prior notice: each food shipment needs advance notice to FDA. A shipment imported without it "shall be refused admission" [25].
  • Foreign Supplier Verification Program (FSVP): your US importer "shall perform" risk-based checks that your food is not adulterated, and must keep the records for at least 2 years [26]. Expect your importer to ask you for documents.
  • GMP (21 CFR Part 111): this applies to supplements "imported or offered for import" [27].
    • You must run at least one identity test on each dietary ingredient [28].
    • You must set finished-batch specifications, including limits on contamination [29].
    • Schedule T is not a substitute. Import Alert 54-14 (supplement GMP failures) lists Patanjali Ayurved, Planet Ayurveda, Chakrapani Ayurveda and Falcon System of Ayurvedic Products [30].
  • New dietary ingredients: this covers any ingredient not marketed in the US before 15 October 1994. Unless the ingredient has been in the food supply without chemical alteration, you must send FDA safety information at least 75 days before marketing. Otherwise the supplement is deemed adulterated [31].
  • Label: this replaces your rule 161A content, which rule 161A lets you adapt to the importing country's law.
    • The term "dietary supplement" must appear [32].
    • Each ingredient must be listed with its quantity, or the total quantity for a proprietary blend [32].
    • Botanicals must name the plant part, expressed in English [33].
    • The label needs a "Supplement Facts" panel [34].
    • Required information must also be in English [35].
    • The label must give a US address or US phone number for adverse event reports [32].
  • Claims: structure/function statements are allowed, but they may not claim to treat or prevent a disease.
    • The label must carry the disclaimer "This statement has not been evaluated by the Food and Drug Administration…" [32].
    • You must notify FDA within 30 days of first marketing with such a statement [36].
  • Serious adverse events: the company named on the label must report each one to FDA within 15 business days and keep records for 6 years [37].

3. Heavy metals: the main border risk for rasaushadhi products

  • Import Alert 99-42 (toxic elements) lists several Baidyanath batis, including Arogyavardhini, Agnitundi and Brahmi Bati. FDA concluded that consuming them "would likely be injurious to health" from lead, mercury or both [38].
  • From 23 October 2026, any test to get a detained shipment released for arsenic, lead, cadmium or mercury "must be conducted" by a lab accredited under FDA's Laboratory Accreditation for Analyses of Foods (LAAF) programme [38].

4. If you sell it as a drug instead

  • You need an approved application [22].
  • Every foreign plant making the drug must register with FDA, name a US agent and the known US importers, and re-register between 1 October and 31 December each year. It must also list its drugs [39].
  • Listing errors are enforced. FDA sent a warning letter to Chennai-based Dr Sankunni's Ayurvedic Research Foundation over balm listings that named the wrong manufacturer. The listings were removed from the NDC Directory [40].

5. Ayurvedic oils, soaps and toothpastes (cosmetics)

  • Under the 2022 cosmetics law (MoCRA), each facility must register within 60 days of starting to make cosmetics for the US, naming a US agent if it is abroad. The responsible person must list each product within 120 days of marketing [41].
  • Colour additives are a frequent problem. Import Alert 53-06 lists Medimix Ayurvedic soaps for non-permitted, uncertified or undeclared colours [42].
  • Medicinal claims move a cosmetic into the drug category. Vicco Vajradanti "Ayurvedic Medicine for Gums and Teeth" toothpaste is on Import Alert 66-41 [22].

Approach: I used the FD&C Act (2023 US Code edition), the current 21 CFR Parts 101 and 111, FDA's active import alerts and its warning letters. I didn't open FDA's own rules in 21 CFR Part 1 that set the detailed procedure for food facility registration, prior notice and FSVP, so the points above come from the Act alone.

If you tell me the product format (a classical bhasma or bati, a herbal capsule or an oil), I can map it to the right US category and check its ingredients against the import alerts.

Q.04