CHAPTER 30

Pharmaceutical products

NOTES

1. This Chapter does not cover:

(a) 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);
(b) plasters specially calcined or finely ground for use in dentistry (heading 2520);
(c) aqueous distillates or aqueous solutions of essential oil, suitable for medicinal uses (heading 3301);
(d) preparations of headings 3303 to 3307, even if they have therapeutic or prophylactic properties;
(e) soap or other products of heading 3401 containing added medicaments;
(f) preparations with a basis of plaster for use in dentistry (heading 3407); or
(g) blood albumin not prepared for therapeutic or prophylactic uses (heading 3502).

2. For the purposes of heading 3002, the expression “modified immunological products” applies only to monoclonal antibodies (MABs), antibody fragments, antibody conjugates and antibody fragment conjugates.

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:

(1) unmixed products dissolved in water;
(2) all goods of Chapter 28 or 29; and
(3) simple vegetable extracts of heading 1302, 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 mixture of vegetable materials; and
(3) 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—

(a) sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) [OLD- suture materials ] and sterile tissue adhesives for surgical wound closure;

(b) sterile laminaria and sterile laminaria tents;

(c) sterile absorbable surgical or dental haemostatics sterile surgical or dental adhesion barriers, whether or not absorbable;

(d) opacifying preparations for X-ray examinations and diagnostic reagents designed to be administered to the patient, being unmixed products put up in measured doses or products consisting of two or more ingredients which have been mixed together for such uses;

(e) blood-grouping reagents;

(f) dental cements and other dental fillings; bone reconstruction cements;

(g) first-aid boxes and kits;

(h) chemical contraceptive preparations based on hormones, on other products of heading 2937 or on spermicides;

(i) gel preparations designed to be used in human or veterinary medicine as a lubricant for parts of the body for surgical operations or physical examinations or as a coupling agent between the body and medical instruments; and

(j) waste pharmaceuticals, that is, pharmaceutical products which are unfit for their original intended purpose due to, for example, expiry of shelf-life.

(k) appliances identifiable for ostomy use, that is, colostomy, ileostomy and urostomy pouches cut to shape and their adhesive wafers or faceplates.

(In Note 4, clause (a) the words "suture materials (including sterile absorbable surgicalor dental yarns)" - substituted, clause (c)- "sterile surgical or dental adhesion barriers, whether or not absorbable;" & clause (k) has been inserted vide Union Budget 2006-2007 -Finance Bill - With effect from the 01/01/2007)

5. This Chapter does not cover pharmaceutical products and medicaments containing alcohol, opium, Indian hemp or other narcotic drugs. For the purposes of this Note, "alcohol", "opium", "Indian hemp", "narcotic drugs" and "narcotics" have the meanings assigned to them in section 2 of the Medicinal and Toilet Preparations (Excise Duties) Act, 1955 (16 of 1955).

6. In relation to products of heading 3003 or 3004, conversion of powder into tablets or capsules, labelling or relabelling of containers intended for consumers or repacking [OLD- labelling or relabelling of containers intended for consumers and repacking ] from bulk packs to retail packs or the adoption of any other treatment to render the product marketable to the consumer, shall amount to manufacture.

(In note 5, the words "labelling or relabelling of containers intended for consumers or repacking" has been substituted vide NTF. NO. 11/2008-CE(N.T.), DT. 01/03/2008)

7. In relation to products of heading 3005, "brand name" means a brand name, whether registered or not, that is to say, a name or a mark, such as a symbol, monogram, label, signature or invented words or any writing which is used in relation to a product, for the purpose of indicating, or so as to indicate, a connection in the course of trade between the product and some person using such name or mark with or without any indication of the identity of that person.