Chapter 30 - Pharmaceutical products

Notes

1. This Chapter does not cover:

foods or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters), other than nutritional preparations for intravenous administration (Section IV);
Preparations, such as tablets, chewing gum or patches (transdermal systems) intended to assist smokers to stop smoking (heading 2106 or 3824);
plasters specially calcined or finely ground for use in dentistry (heading 2520);
aqueous distillates or aqueous solutions of essential suitable for medicinal uses (heading 3301); if
preparations of headings 3303 to 3307, even they have therapeutic or prophylactic properties; (0 soap or other products of heading 3401 containing added medicaments;
preparations with a basis of plaster for use in dentistry (heading 3407); or
blood albumin not prepared for therapeutic or prophylactic uses (heading 3502).

2. For the purposes of heading 3002, the expression "immunological products" applies to peptides and proteins (other than goods of heading 2937) which are directly involved in the regulation of immunological processes, such as monoclonal antibodies chemokines and certain tumor necrosis factors (TINE), growth factors (GF), hematopoietins and colony nal antibodies (MAB), antibody fragments, antibody conjugates and antibody fragment conjugates, interleukins, stimulating factors (CSF).

3. For the purposes of headings 3003 and 3004 and of Note 4(d) to this Chapter, the following are to be treated:

(a) as unmixed products:

unmixed products dissolved in water;
all goods of Chapter 28 or 29; and
simple vegetable extracts of heading 1302, merely standardised or dissolved in any solvent;

(b) as products which have been mixed:

colloidal solutions and suspensions (other than colloidal sulphur);
vegetable extracts obtained by the treatment of mixture of vegetable materials; and
salts and concentrates obtained by evaporating natural mineral waters.

4. Heading 3006 applies only to the following, which are to be classified in that heading and in no other heading of this Schedule-

sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yams) and sterile tissue adhesives for surgical wound closure;
sterile laininaria and sterile laminaria tents;
sterile absorbable surgical or dental haemostatics sterile surgical or dental adhesion barriers, whether or not absorbable;
pacifying preparations for X-ray examinations and diagnostic reagents designed to be administered to the
blood-grouping reagents; patient, being unmixed products put up in measured doses or which have been mixed together for such uses; products consisting of two or more ingredients
dental cements and other dental fillings; bone reconstruction ceme
first-aid boxes and kits; nts;
chemical contraceptive preparations based on hormones, on other products of heading 2937 or on spe 'cides;
gel preparations designed to be used in human or surgical operations or physical examinations or as avecoteurpm1rnrgy medicine as a lubricant for pans of and agent between the body and medical instruments; and
waste pharmaceuticals, that is, pharmaceutical products which arc unlit for their original intended purpose due to, for example, expiry of shelf-life.
appliances identifiable for ostomy use, that is, colostomy, ileostomy and urostomy pouches cut to shape and their adhesive wafers or faceplates.

GST Rates of Goods

Chapter Heading	Description	Rate of GST	Schedule	Sr.No
3003	Following goods namely:—(a) Menthol and menthol crystals, (b) Peppermint (Mentha Oil), (c) Fractionated/de-terpenated mentha oil (DTMO), (d) De-mentholised oil (DMO), (e) Spearmint oil, (f) Mentha piperita oil	5%	I	74
30	Insulin	5%	I	173
3001	Glands and other organs for organo-therapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organ-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included	5%	I	60
3002	Animal or Human Blood Vaccines	5%	I	174
3003	Medicaments (excluding goods of heading 30.02, 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 packings for retail sale, including Ayurvaedic, Unani, Siddha, homoeopathic or Bio-chemic systems medicaments	5%	I	62
3004	Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale, including Ayurvaedic, Unani, homoeopathic siddha or Bio-chemic systems medicaments, put up for retail sale	5%	I	63
3005	Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes	5%	I	64
3006	Animal or Human Blood Vaccines	5%	I	174
3301	Following goods namely:-(a) Menthol and menthol crystals, (b) Peppermint (Mentha Oil), (c) Fractionated/de-terpenated mentha oil (DTMO), (d) De-mentholised oil (DMO), (e) Spearmint oil, (0 Mentha piperita oil	12%	II	74<sup>1</sup>
3302	Following goods namely:—(a) Menthol and menthol crystals, (b) Peppermint (Mentha Oil), (c) Fractionated/de-terpenated mentha oil (DTMO), (d) De-mentholised oil (DMO), (e) Spearmint oil, (f) Mentha piperita oil	5%	I	74
29	Following goods namely:-(a) Menthol and menthol crystals, (b) Peppermint (Mentha Oil), (c) Fractionated/de-terpenated mentha oil (DTMO), (d) De-mentholised oil (DMO), (e) Spearmint oil, (0 Mentha piperita oil	12%	II	74<sup>1</sup>
3003	Following goods namely:-(a) Menthol and menthol crystals, (b) Peppermint (Mentha Oil), (c) Fractionated/de-terpenated mentha oil (DTMO), (d) De-mentholised oil (DMO), (e) Spearmint oil, (0 Mentha piperita oil	12%	II	74<sup>1</sup>
30	Medicaments (including those used in Ayurvedic, Unani, Siddha, Homeopathic or Bio-chemic systems), manufactured exclusively in accordance with the formulae described in the authoritative books specified in the First Schedule to the Drugs and Cosmetics Act, 1940 (23 of 1940) or Homeopathic Pharmacopoeia of India or the United States of America or the United Kingdom or the German Homeopathic Pharmacopoeia, as the case may be, and sold under the name as specified in such books or pharmacopoeia	5%	I	181A<sup>1</sup>
30	Diagnostic kits for detection of all types of hepatitis	5%	I	175
30	Desferrioxamine injection or deferiprone	5%	I	176
30	Cyclosporin	5%	I	177
30	Medicaments (including veterinary medicaments) used in biochemic systems and not bearing a brand name	5%	I	178
30	Oral re-hydration salts	5%	I	179
30	Drugs or medicines including their salts and esters and diagnostic test kits. specified in List I appended to this Schedule	5%	I	180
30	[OR ANY CHAPTER] Drugs or medicines including their salts and esters and diagnostic test kits, specified in List 1 appended to this Schedule	5%	I	180<sup>2</sup>
30	Formulations manufactured from the bulk drugs specified in List 2 appended to this Schedule	5%	I	181
30	Nicotine polacrilex gum	18%	III	41
30	Following goods namely:—(a) Menthol and menthol crystals, (b) Peppermint (Mentha Oil), (c) Fractionated/de-terpenated mentha oil (DTMO), (d) De-mentholised oil (DMO), (e) Spearmint oil, (f) Mentha piperita oil	5%	I	74
3002	Animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; toxins, cultures of micro-organisms (excluding yeasts) and similar products	5%	I	61
3006	Pharmaceutical goods specified in Note 4 to this Chapter [i.e. Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yams) and sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental haemostatics; sterile surgical or denatal adhesion barriers, whether or not absorbable; Waste pharmaceuticals] [other than contraceptives]	5%	I	65
3002	Human blood and its components	0%	-	106
3006	All types of contraceptives	0%	-	107

Other Exemptions

Description	Notification
Exemption from Registration - Small Taxpayers having turnover below threshold limit	Notification No. 10/2019-C.T., dated 7-3-2019
Composition Levy Scheme for Small Taxpayers having Turnover Up to Rs. 1.5 Crore — Old Scheme	Notification No. 8/2017-C.T., dated 27-6-2017
Composition Levy Scheme for Small Taxpayers having Turnover up to Rs. 1.5 Crore — New Scheme	Notification No. 14/2019-C.T., dated 7-3-2019
Scheme to Pay GST @6% - For Taxpayers having turnover less than Rs. 50 Lakhs and Not Eligible for Composition Scheme.	Notification No. 2/2019-C.T. (Rate), dated 7-3-2019
Exemption to Specified Goods supplied to Specified Recipients for Petroleum Exploration etc.	Notification No. 3/2017-Central Tax (Rate), dated 28-6-2017]
Exemption to Goods Supplied to CSD by way of Refund	Notification No. 6/2017-Central Tax (Rate), New Delhi, dated 28-6-2017.
Exemption to goods supplied by CSD	Notification No. 7/2017-Central Tax (Rate), New Delhi, dated 28-6-2017
United Nation, International Organisation and Foreign Diplomatic Mission Notified as Entitled for refund of GST Paid on supplies received.	Notification No. 16/2017-Central Tax (Rate), dated 28-6-2017
Reduced GST on Supply of Goods to Exporter	Notification No. 40/2017-CT. (Rate), dated 23-10-2017
Concessional GST on Supply of Scientific and technical equipment to research institutions	Notification No. 45/2017-C.T. (Rate), dated 14-11-2017

Departmental Clarifications / Case Law

GST rate on Human Blood plasma:

Plasma is the clear, straw coloured liquid portion of blood that remains after red blood cells, white blood cells, platelets and other cellular components have been removed. As per the explanatory notes to the Harmonized System of Nomenclature (HSN), plasma would fall under the description antiscra and other blood fractions, whether or not modified or obtained by means of biotechnological processes and would fall under HS code 3002. Normal human plasma is specifically mentioned at S. No. 186 of List-1 under S. No. 180 of Schedule-1 of the notification No. 112017-Central Tax (Rate), dated 28th June, 2017, and attracts 5% GST. Other items falling under HS Code 3002 (including plasma products) would attract 12% GST under S. No. 61 of Schedule-11 of the said notification, not specifically covered in the said List I. Thus, a harmonious reading of the two entries would mean that normal human plasma would attract 5% GST rate under List I (S. No. 186), whereas plasma products would attract 12% GST rate, if otherwise not specifically covered under the said List. Circular No. 52/26/2018-GST, dated 9-8-2018

Dietary & Health Supplement

Cannot be classified as Medicaments under CTH 3004 in absence of a drug license - appropriately classifiable under 2106 ibid and taxable under Sl. No. 23 of Schedule III of Notification No. 112017-C.T. (Rate). In Re: Eskag Pharma Pvt. Ltd. 2019 (23) G.S.T.L. 395 (A.A.R. - GST).

Glucomannan (Propol A)-Vegetable extracts

Fact that it swells in cold water, is not by itself sufficient to determine its classification as mucilage - Classifiable under sub-heading 1302.19 of the Customs Tariff Act, 1975 and not under Heading 30.03. Commissioner v Cadila Chemicals Ltd., 2002 (139) ELT 362 (Tri. -Mumbai)

Inca Inchi Oil

The Revenue has not even got the product tested by the Drugs Control authorities to come to the conclusion that the product has therapeutic or prophylactic properties or have been prepared or made so as to have these properties. On the contrary, we find that the product description on the packaging itself, clearly indicates that the product does not have any medicinal use and is not intended to diagnose, treat, cure or prevent any disease. Product classifiable as 'Extra virgin vegetable oil' under CTH 1515 90 91 and not as P or P medicines under CM 3004- Supreme Enterprises v Commissioner- 2015 (316) ELT 274 (Tri.- Mumbai).

HIV detection kits and Hepatitis C detection kits containing antigens obtained from micro-organism cultures, immobilised on a porous immuno-filtration membrane and which work on antigen-antibody reaction (neutralisation) would be covered by Heading 30.02 and not under 38.22, J. Mitra & Co. Ltd. v Commissioner. 2013 (288) ELT 229 (Tri.-Del.).

Nickel-Chrome casting alloy for dental use

The product in question does not meet the description under Chapter Heading 30064000 which relates to dental cement and other dental filling. This product is neither dental cement nor other dental filling as description itself says that the product is nickel chrome casting alloy. It is used for the purpose of making crowns, partial bridges etc. which are not in the h' ature of filling. We also see that the product cannot be considered as article of nickel or nickel alloy as called of nickel is less than 99% and the cobalt is totally missing which is essential constituent for alloy to be ailed nickel alloy. However, Rule 3(a) of Rules of Interpretation provides that the heading which provides the most specific description shall be preferred to headings providing more general description. Since in this case the item is essentially alloy. Chapter Heading 75089090 is to be considered as more specific. Even otherwise Rule 3(c) states that if the goods cannot be classified by reference to (a) or (b) they shall be classified under the heading which occurs last in numerical order among those which equally merit consideration. Since in the present case Heading 75089090 is last in numerical order, goods will be classifiable under Chapter Heading 75089090 which covers other article of Nickel and Nickel Alloy. - Varsh Dental Products Pet. Ltd. v Commissioner 2008 (231) ELT 539 (Tri. - Mumbai).

Sterilisation pouches

Sterilisation pouches are different from aseptic packaging paper. Sterilisation pouches fall under heading 3005 and attract 12% GST. CB.L & C Circular F. No. 332/2/2017-TRU, dated 7-12-2017