Plant Extract Classifiable as Medicament Due to Therapeutic Use & Processing: CAAR Mumbai

In re G.C. Chemie Pharmie Limited (CAAR Mumbai)

The Customs Authority for Advance Ruling Mumbai considered an application filed under the Customs Act, 1962 seeking an advance ruling on the classification of “Pelaforce EMA 1170,” a powdered extract derived from the root of the plant Pelargonium Sidoides. The applicant proposed to import the product in bulk from South Africa for use as a raw material in manufacturing tablets, capsules, and syrups intended for prevention and treatment of viral colds, flu, and respiratory tract infections.

The applicant contended that the product should be classified under Customs Tariff Heading 1302 as a vegetable extract. It was submitted that the product contains 70% native plant extract and 30% maltodextrin as a carrier, and is obtained through hydro-ethanolic extraction. Relying on the Harmonized System of Nomenclature (HSN) Explanatory Notes and judicial precedents, the applicant argued that addition of inert substances like maltodextrin does not affect classification under Heading 1302. The applicant further claimed eligibility for concessional customs duty under Notification No. 45/2025-Cus.

The Authority examined the product composition, manufacturing process, intended use, and relevant tariff provisions. It noted that Heading 1302 covers vegetable saps and extracts generally used as raw materials, provided they are not highly refined, purified, or transformed into preparations having the character of food or medicaments. The HSN Notes also exclude products that undergo additional extraction cycles or purification processes beyond initial extraction, or those having therapeutic or prophylactic characteristics as medicaments.

Upon analysis, the Authority found that the product is not a simple or crude plant extract. The manufacturing process involves hydro-ethanolic extraction, concentration, drying, milling, and addition of maltodextrin, resulting in a standardized and refined extract. The Authority observed that the product undergoes multiple stages of processing beyond initial extraction, including purification and stabilization, which takes it outside the scope of Heading 1302.

The Authority further held that the product has a specific therapeutic application and is exclusively supplied to pharmaceutical manufacturers for use in medicaments. It was noted that the product is a standardized medicinal extract with recognized pharmacological properties and is not intended for general use. The addition of maltodextrin as a carrier was considered to facilitate drug delivery, absorption, and stability, without altering the medicinal character of the product.

Referring to Chapter 30 of the Customs Tariff, the Authority observed that Heading 3003 covers medicaments consisting of two or more constituents mixed for therapeutic or prophylactic use, not put up in measured doses. It was concluded that the subject product, comprising active extract and carrier, and intended exclusively for therapeutic use, satisfies the criteria for classification as a medicament under Heading 3003.

The Authority rejected the applicant’s reliance on precedents relating to classification of general plant extracts, noting that the present product is a standardized extract with specific therapeutic identity and cannot be considered a mere botanical extract. It also observed that the product is not classifiable under Chapter 12, as it is not in natural or minimally processed form.

Applying the General Rules for Interpretation, particularly Rule 1 and Rule 3(b), the Authority determined that the essential character of the product is derived from its medicinal efficacy rather than its botanical origin. Accordingly, the product was classified under Heading 3003, specifically under tariff item 3003 90 90 as “other medicaments.”

Consequently, the Authority held that the product is not eligible for concessional duty under Notification No. 45/2025-Cus, as the exemption applies to goods classified under Heading 1302. The ruling clarified that the product, though plant-derived, has evolved through processing and standardization into a medicinal preparation with therapeutic properties.

The application was disposed of with the ruling that “Pelaforce EMA 1170” is classifiable under Customs Tariff Heading 3003 and not under Heading 1302, and is therefore not entitled to the claimed exemption.

FULL TEXT OF THE ORDER OF CUSTOMS AUTHORITY OF ADVANCE RULING, MUMBAI

M/s. G. C. Chemie Pharmic Limited (1EC No.: 0395065895) (hereinafter referred to as the Applicant’) filed an application (CAAR-1) for advance ruling in the^.Office of Secretary, Customs Authority for Advance Ruling (CAAR) Mumbai. The said application was received in the secretariat of the CAAR, Mumbai on 16.12.2025 along with its enclosures in terms of Section 2811 (1) of the Customs Act, 1962 (hereinafter referred to as the ‘Act also’). The Applicant is seeking advance ruliiig on the issue of classification of “Powdered extract derived from the root of the plant Pelargonium Sidoides”. The applicant intends to import the said goods from the ports of^. .INC I1. Nhava-Shwa.and Air Cargo Complex,  Mumbai which is manufactured by A fraceuticals (Pty) Ltd, South Africa and sold under the name “Pelaforce EMA1170^–.

2. Applicant’s Submissions:

2. The applicant submitted that the said Powdered Extract from the Root of the Plant, Pelargonium Sidoides will be imported in bulk and will be supplied to manufacturers for use as raw material/ ingredient in the manufacture of tablets / capsules / syrups meant for preventioll and treatment of viral colds, flu and respiratory tract infections.

3. About Pelaforce EMA 1170- Pelaforce is a soluble vacuum dried powdered extract derived from the root of the plant Pelargonium Sidoides, originating throughout Eastern Cape and Free state of the Republic of South Africa and is obtained using the hydro-ethanolic extraction method. BeloW is the composition and description of the product:

Hereto the manufacture’s process flow chart of the said product as below: –

The manufacturer’s process of “Pelaforce Ema 1170^– is an extract from root of Pelargonium Sidoides plant and is obtained using the hydro-ethanolic extraction method, which involves using a solvent mixture of water and ethanol for extraction.

4. From the above facts, the following points are worthwhile to note:

a. Pelaforce is an extract of Pelargonium Sidoides plant, originating throughout Eastern Cape and Free state of the Republic of South Africa,

b. Pelaforce is obtained using the hydro-ethanolic extraction method, which involves using a solvent mixture of water and ethanol for extraction,

c. The product contains 70 percent native extract of Pelargonium Sidoides, ith the remaining 30 percent being a carrier (maltodextrin),

d. The product will be imported in bulk and will be supplied to manufacturers for use as raw material/ ingredient in the manufacture of tablets / capsules / syrups meant for prevention and treatment of viral colds, flu and respiratory tract infections.

5. Statement containing the applicant’s interpretation of law and/or facts, as the case may be, in respect of the questions(s) on which advance ruling is required:

5.1 In the light of the facts set out herein above, the Applicant seeks advance ruling on the question of classification of `Pelaforce EMA 1170′ (Powdered extract from Roots of the Plant Pelargonium Sidoides) under the Customs Tariff of India and the effective rate Notification issued under Section 25 of the Customs Act 1962 applicable to the said goods.

5.2 It is the Applicant’s interpretation, as elaborated hereinafter, that the said powdered extract being an extract from the roots of the Plant “Pelargonium Sidoides”, the same is Vegetable Extract which is covered by Customs Tariff Heading 13.02, which covers “Vegetable Saps and Extracts”.

5.3 At the outset, it is submitted that the Indian Customs Tariff is aligned, up to the 6-digit level, with the Harmonized System of Nomenclature (1-ISN’) issued by the World Customs Organization (`WC0′). It has been held by the Hon’ble Supreme Court in the case of Collector of Customs. Bombay Vs. Business Forms – 2002 (142) ELT 18 that the I-ISN Explanatory Notes aid in the interpretation of the I leadings of the Tariff and may be used as a safe guide for the same.

5.4 The classificatibn of the goods imported into India is to be determined based on the General Rules of Interpretation (hereinafter referred to as the “GR1”) set out in the Tariff. As per Rule I of the GRI, classification of the imported products shall be determined according to the terms of the headings and any relative Section or Chapter Notes.

5.5 The product is a soluble vacuum-dried powder extract which is derived from the root of the plant i.e., Pelargonium Sicloides by using hydro-ethanolic extraction method. Plant extracts arc specifically, covered under Heading 1302. Tariff heading 1302 of the Customs Tariff covers vegetable saps and extracts; pectic substances, pectinates and pectates; agar-agar and other mucilages and thickeners, whether or not modified, derived from vegetable products. The said heading. to the extent relevant for extracts, is reproduced below for ready reference:

5.6 From the above, it can be seen that the product in question can be grouped under `Tariff I leading 1302 due to its origin and characteristics. The product contains 70 percent native extract of Pelargonium Sidoides, with the remaining 30 percent being a carrier (maltodextrin). The product is primarily composed of the root extract of the Pelargonium Sidoides plant, thus, the same is correctly classifiable under Chapter Heading 1302. The addition of Maltodextrin, an inert substance, which acts as carrier, does not affect the classification of the said extract under lleading 13.02 in view of the IISN Notes under Heading 13.02 which state as follows:

“Solid extracts are obtained by evaporating the solvent. Inert substances are sometimes added to certain extracts so that they can be more easily reduced to powder (e.g., belladonna extract, to which powdered gum Arabic is added), or to obtain a standard strength (for instance, certain quantities of starch are added to opium in order to obtain a product containing a known portion of morphine). The addition of such substances does not affect the classification of these solid extracts.” (emphasis supplied)

6. The relevant HSN Explanatory Notes to Chapter heading 1302 of World Customs Organization (“WCO”) are also reproduced for ease of reference:

7. The explanation provided for Tarifflleading 13.02 in the IISN Explanatory Notes clarifies that extracts are covered under this heading, provided they arc not specified or included in more specific headings of the nomenclature. It is also mentioned that extracts under this heading (1302) arc usually obtained by extraction using solvents. Further, as per Notes, Extracts may be simple or compound. Simple extracts are obtained by the treatment of only one variety of plant. Compound extracts arc obtained either by mixing simple extracts or by treating mixtures of different varieties of plants.

8. As noted above, the product is an extract of Pelargonium Sidoides plant and is obtained using the hydroethanolic extraction method, which involves using a solvent mixture of water and ethanol to extract compounds from plant materials. In this case, 11% ethanol and water arc the extraction solvents used. Therefore, the product in question satisfies the conditions prescribed in the IISN Explanatory Notes for Chapter I leading 1302. The IISN Note also refers to ‘Others’ covered under 1302.19. tinder 1 leading 13.02 of Indian Customs Tariff, “Pelargonium Sidoides root Extract Powder” is correctly classifiable as “Other” Vegetable Extract under the Cour dash (—-) Sub-heading 13021919, which falls under the triple dash (—) description of “Extracts”, which falls under double dash (–) sub-heading “Other”, which falls under single dash (-) description of Vegetable saps and extracts.

9. The I ISN Explanatory Notes to I leading 1302 also provides that this I leading covers vegetable saps and extracts which are generally used as raw materials for various manufactured products. In the instant case, the product will be brought into India as a raw material in powder form and then same will be used for manufacturing tablets/ syrups used to provent and treat viral colds, flu and respiratory tract infections.

10. Further, according to the IISN Notes, products cannot be classified under Heading 1302 if, due to the addition of other ingredients, they take on the characteristics of food preparations, medicaments or similar products. In the present case, the product contains 70 percent native, extract of Pelargon Sidoides, with the remaining 30 percent being a carrier (maltodextrin). The product
is primarily composed of the root extract of the Pelargonium Sidoides plant and, as such, is correctly classifiable under Chapter I leading 1302.

11. Furthermore, in terms of I ISN Notes, products are excluded from the heading 1302 when they are highly refined or purified, e.g., by means of chromatographic purification, ultrafiltration, or additional extraction Cycles (e.g. liquid-liquid extraction) following initial extraction.). In the instant case, product is obtained from Pelargonium Sidoides plant by using simple initial extraction process i.e., the hydro-ethanol ic extraction method, which involves using a solvent mixture of water and ethanol to extract compounds from plant materials. Therefore, the product in question meets this condition, as no additional extraction process/ ultra purification/ chromatographic purification is carried out after the initial extraction.

12. Reliance is placed on the decision in Cachet Pharmaceuticals (P) Ltd. Versus Commr. Of Customs, New Delhi 2017 (356) E.L.T. 300 (Tri. – Del.), in which, it is held that Ginseng extract powder is correctly classifiable under Heading 13.02 and also placed on US Customs Ruling N241904 dated 4^th June 2013, in which Corn Silk extract powder, to which Maltodextrin was added as Carrier, is held to fall under Heading 13.02.

13. In view of the above discussion, as the product in question is a plant extract used as raw material for manufacturing an end product, the product clearly merits classification under C”Il I 13021919 of the Customs Tariff Act. Further, all goods of I leading 1302 19, other than vegetable seeds and extracts of pyrethrum or of the roots plants containing rotenone, are eligible for partial exemption from customs duty in excess of 15% under Sr. No.37 of  Notification No. 45/2025-Customs, dated October 24, 2025. Since the subject goods are not extract of Pyrethrum, nor of roots of plant containing rotenone, the same are covered by the said Sr. No.37 and eligible for effective rate of customs duty of 15%.

14. Vide additional submission submitted on 02.03.2026, the applicant stated that:

14.1 The illustrations/examples of vegetable extracts given in the I ISN notes under Heading13.02 include medicinal plant extracts such as Belladona, etc. It therefore follows that extract of the root of the plant Pelargonium Sidoides, which has medicinal properties, is rightly classifiable under Heading 13.02. Further, the FISN notes under I leading 13.02 clearly mention that inert substances can be added to such extracts so that they can be more easily reduced to powder and example is given of addition of Gum Arabic to Belladona Extract. It is provided in the said Notes that addition of such substances does not affect the classification or these extracts under I leading 13.02.

14.2 In the Pelargonium Sidoides Extract, which we propose to import, there is addition of Maltodextrin as Carrier, to the extent of 30%, as evident from the Manufacturer’s Certificate of Analysis appearing in the Application.

14.3 Further, the applicant stated that Maltodextrin is inert carrier material which is adkkd to Plant extract powders and is similar to the example of (him Arabic given in HSN note. In support of this the applicant submitted the following:

US  Patent Application publication dated 6-5-2010 appearing on webs i te https://patentirnages.storage.googleapis.com/d2/b5/43/501f50513i1116e/US20100112096A1 .pdf relating to Dry Extract of Pelargonium Sidoides, which in Para 100181 mentions Maltodextrin as one of the suitable carriers added to dry extract if Pelargonium Sidoides.

14.4  Further it would be evident from the following literature that addition of Maltodextrin as carrier in spray dried powder to the extent of 30% is normal:

• Extract from the article appearing on v ebsite
  https://pubs.rsc.org/en/content/articlepdf/2023/tb/d3tb00008g bearing the title “Optimization of spray-drying conditions using response surface methodology, physico-chemical characterization and shelf-life estimation of pineapple powder”. which shows study conducted with 30-50% Maltodextrin and optimization condition was Maltodextrin content of 40.83%.
• Extract from the article appearing On \\ ebsite
  https://www.sciencedirect.com/science/article/pii/S2772502223000963 bearing the title “The effect of maltodextrin and drying temperature on the characteristics of Aloe-bignay instant drink”, which show.s concentration of maltodextrin of 30% to be the best.

14.5 Further, reliance is placed on the following US Customs Ruling which holds that the presence of inert carrier such as Maltodextrin in the Vegetable Extract powders does not affect their classification under Heading, 13.02 irrespective of the percentage of the Carrier:

IS Customs Ruling HQ H225004 dated 10 Nov 2015:

In particular, attention is drawn to the following para appearing in the said ruling:

‘However, we note that the FN carves out exceptions for products that after simple extraction, have been mixed with other simple extracts to form compound extracts or have been supplemented with inert materials. With regard to the latter, moreover, the EN does not cap the quantity of inert materials that may be added to a particular extract. It instead states simply that “the addition of such substances does not affect the classification of these solid extracts.” Accordingly, CBP has allowed classification of mixtures containing extracts and inert substances in heading 1302 even where the inert components predominate the chemical composition of the mixture. See New York Ruling Letter (NY) N243060. dated July 2. 2013 (classifying product containing 2 percent Sophora Japonica Lea fIxtract and 98 percent maltodextrin, the latter of which was used as a filler, in heading 1302); NY NO1 5474, dated August 27, 2007 (classifying product comprised 86 percent of maltodextrin, 8 percent of gum, and 6 percent of vanilla extract in heading 1302); and NY N009379, dated May 9. 2007 (classifying products comprised 60 percent of cocoa e \tract and 40 percent ofa starch carrier in heading 1302).”

14.6 In view of the above. it is submitted that presence of 30% Maltodextrin. which is inert carrier. in the Pelargoniums Sidoides Root extract powder. does not affect the classification of the Root c\ tract powder under Heading 13.02.

15. Port of Import and reply from jurisdictional Commissioner (Import), ACC, Mumbai and .INCH, Nhava Sheva, Uran.

The applicant in their CAAR-I indicated that they intend to import the subject goods from the jurisdiction of Office of the Commissioner of Customs, Air Cargo Complex (Import). Mumbai and Nhava Sheva (Import), Uran, Raigad. The applications were forwarded to the Office of the Commissioner of Customs, Air Cargo Complex (Import), Mumbai and Nhava Sheva (Import), Uran, Raigad for their comments on 22.12.2025, 08.01.2026, 28.01.2026 and 16.02.2026, however, no replies have been received in this regard.

16. Details of Personal Hearing: –

Shri .1. C. Patel, Advocate (AR) appeared for Personal Hearing in this matter on 23.02.2026. 1 le reiterated the submission filed with the application that the subject import goods arc PFLAFORCE-EMA 1170, Pelargonium Sidoides extract with native extract 70% with 30% carrier (Maltodextrin). That the subject goods are obtained through Alcohol extraction method (as per Flow Chart given) and that it merits classification under CTH 1302, more particularly under CT1 13021919 under vegetable saps and extracts, extracts —Other.

The learned AR, replies upon the I ISN explanatory Note to the Chapter !leading 1302, which covers vegetable saps and extract. The subject goods arc to be used in manufacturing of supplements having medicinal properties. He further contented that the benefit of Sr. No. 37 of the  Notification No. 45/2025-Customs, dated October 24, 2025. He in support of their claim relied upon case laws: US Customs ruling —N241904 dated 04.06.2013, Catchet Pharmaceuticals (P) Ltd. Vs. Commissioner of Customs, New Delhi (‘Fri. -Del.).

Nobody appeared for Personal I fearing from the department side.

17. and findings: –

17.1 The have considered all the materials placed before me in respect of the classification of subject goods. I have gone through the submissions made by the applicant during the personal hearing on 23.02.204 Therefore, I proceed to ‘Pronounce a ruling on the basis of information available on record as well as existing legal framework. The issue before me pertains to the classification of ” Powdered extract derived from the root of the plant Pelargonium Sidoides, marketed as Pelaforce EMAI 170″ and exemption from customs duty in excess of 15% under Sr. No. 37 of  Notification No. 45/2025-Customs, dated October 24, 2025

17.2  At the outset, I find that the issue raised by the applicant squarely falls within the ambit of Section 28H(2)(a) of the Customs Act, 1962, as it relates to the classification of goods under the Customs Tariff Act, 1975.

17.3 The Applicant submitted that the product should be classified under^–‘1’ariff I leading 1302 of the First Schedule to the Customs Tariff Act, 1975, which covers:

“Vegetable saps and extracts: pectic substances, pectinates and pectates: agar-agar and other mucilages and thickeners, whether or not modified, derived from vegetable products.”

More specifically, the Applicant proposes classification under CTI I 1302 19 19 – Other vegetable extracts. The Applicant relics upon General Rules for Interpretation (GRI) of the Customs lari If, I ISN Explanatory Notes to 1 leading 1302, decision in M/s. Cachet Pharmaceuticals Pvt Ltd vs. Commissioner of Customs, New Delhi (2017), wherein ginseng extract powder w as classified under I leading 1302 and US Customs ruling classifying corn silk extract powder with maltodextrin carrier under heading 1302.

17.4 The product proposed to be imported by applicant is described as Pelaforce EMA 1 170, a powdered plant extract derived from the root of the plant Pelargonium Sidoides. Product details as under:

The applicant further submitted that the manufacturing process involves hydro-ethanolic extraction ofthe root, concentration of the extract, and subsequent vacuum drying to obtain powder, with maltodextrin added as a carrier. The imported product will be imported in bulk form, supplied to pharmaceutical manufacturers and used as a raw material / ingredient in manufacturing of Tablets, Capsules and Syrups. These finished formulations are intended for prevention and treatment of viral colas, flu, and respiratory tract infections.

17.5 .1 have carefully examined the application, the submissions made by the Applicant, the product literature, manufacturing process, and the relevant tariff provisions.

• Relevant Tari ff Ileading 1302 covers:

“Vegetable saps and extracts: pectic substances, pectinates and pectates; agar-agar and other mucilages and thickeners derived from vegetable products”.

Subheading 1302.19 covers other vegetable extracts.

• • ³     The 11SN Explanatory Notes state that I leading 1302 covers:

“Saps are usually thickened or solidified. Extracts may be in liquid, paste or solid farm. “Tinctures” are extracts still dissolved in the alcohol by means of which they are extracted; the so-culled ‘fluid extracts” arc solutions of extracts in, for example, alcohol, glycerol or mineral oil. Tinctures and fluid extracts are generally standardised (far instance, pyrethrum extract mar be standardised by adding mineral oil to produce commercial grades with a standard prrethriiis content of e.g 2%, 20% or 25%). Solid extracts are obtained hi’ evaporating the solvent. inert substances are sometimes added to certain extracts so that they can be more easily reduced to powder (e.g. belladonna extract, to which powdered gum Arabic is added) or to obtain a standard strength (for instance, certain quantities of starch are added to opium in order to obtain a product containing a known portion of morphine). The addition of such substances does not affect the classification of these solid extracts. however, extracts may not be subjected to additional evtraction cycles or to purification processes, such as chromatographic purification that increase or decrease certain compounds or compound classes to a degree that cannot be achieved solely by nleans of initial solvent extraction.

Extracts may he simple or compound. Simple extracts are obtained by the treatment of only one variety of plant. C.’ompound extracts are obtained either by mixing simple extracts or by treating mixtures of different varieties of plants. Compound extracts (whether in the form of alcoholic tinctures or in any other, farms) therefore contain the constituents of several kinds of plants; they include compound jalap extract, compound extract of aloes. compound extract of cinchona etc.

The vegetable saps and extracts of this heading are generally ravtw materials for various manufactured products. They are excluded from the heading when, because of the addition of other substances, they have the character of food preparations, medicaments etc. They are also excluded

_.from the heading when they are highly refined or purified, e.g. by mean.)hie purification, ultrafiltration, or additional extraction cycles (e.g liquid-liquid extraction) following initial extraction.

Certain products of this heading, which are regarded as narcotic clrz.igs under interfultional instruments. are indicated in the list appearing at the end of Chapter 29.

Examples of excluded preparations are:

i. Flavoured syrups containing vegetable extracts (heading 21.06).

ii. Preparations used for making beverages. These preparations are obtained hr compounding vegetable extracts of this heading with lactic acid, tartaric acid, citric acid, phosphoric acid, preserving agents, foaming agents, fruit juices, etc. and sometimes with essential oils. Tlu.’ preparations thus obtained are generally classified in heading 21.06 or 33.02.

iii. Medicinal preparations (some of^–which are also known as “tinctures”) consisting Of mixtures of vegetable extracts with other products (e.g preparations which consist of a mixture of extract of capsicum, spirits of turpentine, camphor and methyl salicylate, or of^. a mixture of tincture of opium, anise oil, camphor and benzoic -acid) (heading 30.03 or 30.00.

iv. Intermediate products for the manufacture of insecticides, consisting of’ pyrethrum extracts diluted by addition of mineral oil in such quantities that the pyrethrins content is less than 2% or with other substances such as synergists (e.g. piperonyl butoxide) added (heading 38.08).

The heading also excludes vegetable extracts which have been mixed or compounded (with.out the addition of other substances) for therapeutic or prophylactic purpose. Such mixtures and similar medicinal compound extracts made by treating a mixture of plants are classified in heading 30.03 or 30.04. That latter heading also covers simple vegetable (.vtracts (whether or not standardised or dissolved in any solvent) when put up in measured doses fin- therapeutic or prophylactic purposes or in, brms or pickings for retail sale for such purposes.

17.6 I observe that extracts of this chapter heading are generally raw material for various manufactured products.. They arc excluded from this heading when, due to the addition of other substances, they attain the character of foods preparation, medicaments etc. I find that the subject goods fall out of the purview of the CTI1 1302 for the following reasons:

• This product is for specific use rather than a general use. The process of manufacturing of “Powdered extract derived from the root of the plant Pelargonium Sidoides” involved hydro-ethanolic extraction of the root, concentration of the extract, and subsequent vacuum drying to obtain powder, with maltodextrin added as a carrier. The subject good has been manufactured by adopting various comprehensive process which involves of milling of raw materials extraction by in process of water and alcohol decanted and filtered. The said process is a systematic manufacturing process. The extensive processing involving after ethanol extraction, Drying/vacuuming, milling and filtering clearly leads the resultant product Out of the scope of the CTI1 1302.
• Extracts in this case, undergoes fOrther additional extraction cycles/purification processes, after achieving first round of liquid solvent extraction. The liquid extraction is further dried/evaporated, alcohol is recovered, to obtain solid and pure Pelargonium. The first phase of extraction is liquid extraction and then in the second phase solid extraction is made. That the pure and solid substance -so extracted is milled to attain 100% pure and refined Pelargonium Sidoides. After that, the carrier maltodextrin is added. The carrier itself does not change the essential character of the product in as much as it is used as a binding agent and works like fillers and bulking agent. Maltodexti•in is widely used in food products and pharmaceuticals.

• It is clearly mentioned in Excluded preparation under the I ISN Explanatory Notes to the Ileading 1302 which reads as per follows:

“Medicinal preparations consisting of mixtures of vegetable extracts with other products (e.g., preparations which consist of a mixture of extract of capsicum, vpirits of turpentine. camphor and methyl salicylate, or of a mixture of tincture of opium, amse oil, camphor and hcn:oic acid) (Heading 30.03 or 30.04).”

“The heading also excludes vegetable extracts which have been mixed or compounded (without the addition of other substances) for therapeutic or prophylactic purposes. Such mixtures, and similar medicinal compound extracts made by treating a mixture of plants. are classified in heading 30.03 or 30.04. That latter heading also covers simple vegetable extracts (whether or riot standardised or dissolved in any solvent) when put up in measured doses fbr therapeutic or prophylactic purposes or in forms or pickings _.for retail sale for such putposes.”

17.7 Furthermore, the product is a hydro-ethanolic extract of Pelargonium sidoides root in vacuum-dried powder form, standardized and purest form with 70% active extract and 30% maltodextrin (carrier). The subject product is imported in bulk and supplied exclusively to pharmaceutical manufacturers for used in preparation of medicaments for viral cold, influenza and respiratory tract infections. It is cleared that the imported product is not a crude extract but a standardized therapeutic extract, obtained through controlled hydro-ethanolic extraction, concentration and drying and addition of maltodextrin as pharmaceutical carrier. This results in pharmaceutically usable intermediate, not a mere botanical extract. The product is not sold for general use, exclusively supplied to pharmaceutical manufacturers and has a specific therapeutic application. Thus, it possesses the essential character of a medicament. Fie onium sidoides together with the carrier (Maltodextrin in this case) in powder form can be taken with water. The carrier is primarily used to enhance drug delivery system, effective drug administration, aids absorption, controls release and stabilizes the active ingredients. Addition of carrier does not change the character of the drugs/medicaments, in whatever form it is added in the active ingredients whether it is in form of powder, tablets, capsules, syrups, pills/gels etc.

18. Interpretation of Heading 3003 covers medicaments not in dosage form. The product having therapeutic/prophylactic use and mixed constituents. Hence, intended exclusively for therapeutic use. Relevant  heading  3003  as under:

• And includes in this heading 3003 is under:

(2) Preparations containing a single pharmaceutical substance together with an excipient. sweetening agent, agglomerating agent, support, etc.

(5) Medicinal compound vegetable extracts including those obtained by treating a mixture of plants.

• Relevant Notes of Chapter 30- “Pharmaceutical Products” as under: –

3,- For me purposes of headings 30.03 and 30.04 and of Note 4 (d) to this Chapter, the following are to be treated :

(a) As unmixed products :

1. Unmixed products dissolved in water;

2. All goods of Chapter 28 or 29; and

3. Simple vegetable extracts of heading 13.02, merely standardised or dissolved in any solvent.,

(b) As products which have been mixed :

1. Colloidal solutions and suspensions (other than colloidal sulphur);

2. ‘Vegetable extracts obtained by the treatment of mixtures of vegetable materials; and

3. Salts and concentrates obtained by evaporating natural mineral waters.

4. Relevant notes 06 of Chater Heading 3003- ^–Medicaments (excluding goods of heading 30.03, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packing for retail sale” as under:

(6) Medicinal mixtures of the plants or parts of plants of heading 1211.

• Relevant Chapter 1 leading 12.11 and notes as under:

12,1.1 – Plants and parts of plants (including seeds and fruits), of a kind used primarily in perfumery, in pharmacy or for insecticidal, fungicidal or similar purposes, fresh. chilled, frozen or dried. v, heater or not cut, crushed or powdered.

19. I observe that the subject goods are not in natural form, it is processed, treated and manufacture goods. I leading 1211 covers only dried herbs, roots (raw or cut) and plant materials in natural or minimally processed form. Heading 1211 applies only when goods are whole/cut/dried plant parts, crushed or powdered (simple processing only), not chemically extracted or processed.

In the present case, the subject good are hydro ethanolic extraction performed, active compounds separated and concentrated, further underwent vacuum drying and added with maltodextrin. Maltodextrin is used as a carrier only. I knee, the character of the preparation as a whole is not affected, rather, the addition of carrier makes it more convenient for preparing a measured dose capsule/tablet. As the substance is soluble in water, it can directly be administered for therapeutic usage. The I ISN Explanatory Notes to the Chapter 1211 clearly provides that “the term within the meaning of Heading 3003 or 3004 refers only to the products which have  therapeutic or prophylactic usage. That the pharmacy has reference both  to medicaments. and to products having no therapeutic or prophylactic usage”. This is beyond simple processing. Hence, “Powdered extract derived from the root of the plant Pelargonium Sidoides” cannot fall under Chapter 12. It will further be unable to be classified under Chapter 1302 due to the highly refined and purified form by the way of the additional extraction cycle following initial extraction in alcohol

20. The subject good is not a crude extract but a standardized medicinal extract, having well known usage in common trade parlance, pharmacological relevancy and utility. The scope of I leading 3003 is endorsed by medicament, multiple constituents therein, having therapeutic use and not being put up in measured doses or retail sale pack. The subject good contains two constituents, (active extract, maltodextrin: carrier), having recognized therapeutic use and is being imported in hulk form. I fence, the subject goods are correctly covered under heading 3003. The essential character is derived from its medicinal efficacy and therapeutic quality and not from its botanical origin alone. The product is not traded as a general extract, it is considered and recognized as active medicinal preparations.

2.1. The reliance on M/s. Cachet Pharmaceuticals (P) Ltd. v. Commissioner of^–Customs, New Delhi has been carefully examined. It is observed that in the Cachet case the product concerned with general plant extracts, retained character ofa primary botanical extract and not shown to have exclusive therapeutic identity. The product in the present case is a standardized, pharmacologically characterized extract with consistent therapeutic properties and it is not capable of general or alternative use. ‘[‘here are a number of standard literature and information about commercial medicinal uses of the said goods.

22. Furthermore, I also find that the applicant has also claimed the benefit under Notification No. 45/2025-Customs, dated October 24, 2025. This product is classified under I ISN 3003 (Chapter 30), it will not be eligible for concessional duty under the said notification. In view of the forgoing facts and discussion it can safely be concluded that the product, though derived from a plant, has evolved through processing and standardization into a medicamen intermediate, and therefore merits classification under Chapter 30 (I ISN 3003) rather than under Chapter 13. Further, the applicant has relied upon the ratio of the above case laws which is irrelevant in as much as the product in the instant case is not a crude extract. It is rather standardized extract and is possessing specific therapeutic qualities and is well recognized in the market for the same.

23. I also find through various open sources/scientific platforms (i.e. PubMed, ScienceDirect, WebMI) and ResearchGate etc.) that the subject product is standardized, pharmacologically characterized extract with consistent therapeutic qualities and is a clinically proven medicinal substance.

Some such references arc given below:

i. As per com: Pelargonium sidoides DC. (Geraniaccac), a popular medicinal plant used in traditional medicine in the treatment of gastrointestinal ailments has been transformed into a phytopharmaceutical (EPs’ 7360) for treating respiratory tract infections.

ii. As per com: The product is effective for

• • Short-term swelling (inflammation) of the airways in the lungs (acute bronchitis). Taking a specific Pelargonium sidoidcs extract ((El’s 7630, Dr. Willmar Schwabe Pharmaceuticals) by mouth within 48 hours of recline, sick seems to help speed up recovery from bronchitis.
  • A lung disease that makes it harder to breathe (chronic obstructive pulmonary disease or COPD). Taking a specific Pelargonium sidoides extract (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) by mouth along with standard treatment seems to reduce the number of COPD flares in people with moderate or severe COPD. It might also reduce the need for antibiotics.

• • Common cold. Taking a specific Pelargonium sidoides extract (F,Ps 7630, Dr. Willmar Schwabe Pharmaceuticals) by mouth might help reduce symptoms and speed up recovery from a cold.

iii. As per ScienceDirect.com: “In areas of southern Africa, aqueous extracts from the roots of Pelargonium sidoides arc employed to cure various disorders. Nowadays, a modern formulation (F,Ps 7630), elaborated from the traditional herbal medicine, is successfully used for the treatment of respiratory tract diseases. We previously observed that root extracts of P. sidoides and their representative constituents exhibit moderate antibacterial and significant immunomodulatory capabilities. The present study was performed to further assess the efficacy and mode of action for these pharmacological activities. The results indicate that P. sidoides extracts may well possess antimycobacterial activity as claimed in traditional uses. Furthermore, significant antibacterial properties against multi-resistant Staphylococcus aureus strains as well as TNILinducing potencies and prominent interferon-like activities in supernatants of sample-activated bone marrow-derived macrophages were observed using several functional assays.

iv. As Per com: “Pelargonium sidoides DC is an interesting plant with various biological properties. Pharmaceutical companies and manufacturers of food supplements arc particularly interested in its beneficial effects in upper respiratory tract infections.

v. As per EBSCO,com: Therapeutic Uses

“An alcohol extract made from P. sidoides has become popular in Germany as a treatment for various respiratory problems, including acute bronchitis, the common cold, sinusitis, pharyngitis (sore throat), and tonsillitis. Fairly large studies have been performed to substantiate some  of these uses.

24. It is gathered through the open sources that Eps 7630 in particular, is not a general sc lent i lie abbreviation rather is a manufacture internal code, for example, it is proprietary designation used by the German Company Dr. Wilmer and refers to the specific standard extract batch/process. It is to be underlined that EMA I 17, as available in open sources, is a pharma grade commercial extract name (e.g. Pelaforce) and is manufactured according to Eurqpean Medicines Agency (EMA) herbal  nomograph standards.

25. I observe that, General Rule of Interpretation, GRI 1 provides that classification of goods shall he determined according. to the terms of “the headings of the tariff schedule and any relative SCW011 01 ChaV,CV notes. In the event that the goods cannot be classified solely^, on the basis of GRI

Heading 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic usage, not put up in measured dosage or in forms or packaging for retails sale. Further, the General Rule of Interpretation Rule 3(b) provides that when goods are mixtures, composite goods and they cannot be classified under GRI 3(a) then classification will be based on material or component that gives the goods their essential character.

25.1 In the instant case, the subject good Pelaforce EMAI 170 is a water soluble vacuum dried pure and relined powdered extract (with added maltodextrin carrier) which is extracted through various extractions cycles and popularly known in trade parlance as traditional medicine and treatment of respiratory tract diseases, inflammation, gastro intestinal ailments etc. merit classification under CM 3003. It is also observed that it is not an Indian traditional Avurvedic medicine nor a classical Homeopathic medicine. It is however, a conventional herbal medicaments and traditionally used in Africa. I !once, CTI 30039090 is most appropriate for the classification chi the same.

26. In the above facts and circumstances of the case, foregoing observations and discussions, I reach to conclusion that the subject goods Pelaforce EMA1170, described as powdered extract derived from the root of the plant Pelargonium Sidoides as per the given process (para 3 above), is classifiable under Customs Tariff I leading 3003, specifically under I IS Code 3003 90 90 — Other of the First Schedule to the Customs Tariff Act, .1975, in terms of General Rule of Interpretation, (iI It Ruler (specific Heading) and GI R-313(essential  character of the goods).
It is implicit that the relevant regulatory mechanism pertaining to the import of the said goods is to he complied with, if any.

26.1The subject good Pelaforce EMA1 170 is not eligible for the benefit of concessional rate of dut) under Notification No. 45/2025-Cus dated 24.10.2025.

27. I rule accordingly.