Compliance Requirements under the Rules

1. Labelling of Drugs as per prescribed in Drug Rules (Rule 95)

Subject to the other provisions of these rules, no person shall sell or distribute any drug (including a patent or proprietary medicine) unless it is labelled in accordance with these rules.

2. Proper Contents on Packaging and Labelling (Rule 96)

Drug labels must show the generic name in larger font than the brand, net content in metric units, active ingredients per dose, manufacturer’s name/address, batch number, licence number, manufacturing & expiry dates, “Physician’s sample” tag (if applicable), and alcohol content if 3% or more.

1. 1. Proper drug name must be printed in larger font than brand name on every container and label.
   2. Label must clearly state net content in metric system—weight, volume, or number of units.
   3. Active ingredients must be labelled per dosage unit—ml, mg, %, etc., as per drug form.
   4. Name and address of the manufacturing premises must be on every container label.
   5. Each container must carry a distinctive batch number for traceability of production.
   6. Drug containers must mention the manufacturing licence number with proper prefix.
   7. Drugs must have labelled manufacture and expiry dates as per Schedule P or 60-month rule.
   8. Samples for medical professionals must be labelled “Physician’s sample—Not to be sold.
   9. If alcohol content is 3% or more, it must be declared on the label as volume percentage.

3. Drugs under Sch G, H, H1, X must have red-boxed warning labels in black font (Rule 96 (1) (xi))

The label of inner most container of the following categories of drugs and every other covering in which the container is packed shall bear a caution or warning depending on whether the drug is covered under Sch G/H/H1/X, as specified in rule 97, in legible black coloured font size in a completely red rectangular box without disturbing other conditions printed on the label under these rules Narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycaemic, antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer drugs and all other drugs falling under Sch G, H, H 1 and X whether covered or not in the above list: Provided that if any of the drug referred above category is not covered under any of the Schedule, namely, Sch G,H,H1 and X, the label of inner most container of drugs and every other covering in which the container is packed shall bear caution or warning applicable for that drugs covered under Sch H as specified in rule 97

4. Imported Drugs Labelling (Rule 96 (1) (xii))

Drugs and their preparations including combinations with other drugs imported into the country shall also bear on the label, the licence number under which the drug is imported, preceded by the words “Import Licence” and the name and address of the importer

5. Labelling of Marketer’s Details (Rule 96 (1) (xiii))

Name of the marketer of the drug and its address, in case the drug is marketed by a marketer: Provided that if the drug is contained in an ampoule or a similar small container, it shall be enough if only the name of the marketer is shown

6. Label of Mechanical Contraceptive (Rule 96 (2))

The particulars to be printed or written on the label of a mechanical contraceptive shall be as specified in Schedule R. The following particulars, in addition-

(a) the date of manufacture;

(b) the date up to which the contraceptive is expected to retain its properties;

(c) the storage conditions necessary for preserving the properties of the contraceptive up to the date indicated in sub-clause (b):

7. Labelling of Vaccines, Sutures, etc (Rule 96 (3))

Vaccines, sutures, and similar items must display required information either on the container or the outer wrapper. These must be indelibly marked or affixed to packaging. Transparent or transport-only coverings are exempt.

8. Etching on Containers (Rule 96 (4))

Where by any provision of these rules any particulars are required to be displayed on a label on the container such particulars may, instead of being displayed on a label, be etched, painted or otherwise indelibly marked on the container: Provided that, except where otherwise provided in these rules, the name of the drug or any distinctive letters intended to refer to the drug shall not be etched, painted or otherwise indelibly marked on any glass container other than ampoules.

9. QR Code for APIs (Rule 96 (5))

Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing.

(i) Unique product identification code,

(ii) Name of the API,

(iii) Brand name (if any),

(iv) Name and address of the manufacturer,

(v) Batch no.,

(vi) Batch size,

(vii) Date of manufacturing,

(viii) Date of expiry or retesting,

(ix) Serial shipping container code,

(x) Manufacturing licence no. or import licence no.

(xi) Special storage conditions required (if any).

10. QR/Barcode on Schedule H2 Drugs (Rule 96 (6))

Manufacturers of drug formulation products as specified in Sch H2 shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication.

The stored data or information referred to in sub-rule (6) shall include the following particulars, namely:—

(i) unique product identification code;

(ii) proper and generic name of the drug;

(iii) brand name;

(iv) name and address of the manufacturer;

(v) batch number;

(vi) date of manufacturing;

(vii) date of expiry; and

(viii) manufacturing licence number.

11. Labelling of medicine under Schedule G (Rule 97 (a))

If it contains a drug substance specified in Schedule G, be labelled with following words in legible black coloured font size in completely red rectangular box: SCHEDULE G PRESCRIPTION DRUG – CAUTION It is dangerous to take this preparation except under medical supervision.

12. Labelling of medicine under Schedule H (other than covered under narcotics) (Rule 97 (b))

If it contains a drug substance specified in Schedule H, be labelled with symbol Rx and with the following words in legible black coloured font size in completely red box SCHEDULE H PRESCRIPTION DRUG – CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner

13. Labelling of medicine under Schedule H (under narcotics) (Rule 97 (c))

If it contains a drug substance specified in Schedule H and comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 be labelled with symbol NRx, which shall be in red and conspicuously displayed on the left top comer of the label and shall also be labelled with the following words in legible black coloured font size in completely red rectangular box: SCHEDULE H PRESCRIPTION DRUG – WARNING To be sold by retail on the prescription of a Registered Medical Practitioner only.

14. Labelling of medicine under Schedule X (Rule 97 (d))

If it contains a drug substance specified in Schedule X, be labelled with symbol XRx, which shall be in red and conspicuously displayed on the left top comer of the label and shall also be labelled with the following words in legible black coloured font size in completely red rectangular box: SCHEDULE X PRESCRIPTION DRUG – WARNING To be sold by retail on the prescription of a Registered Medical Practitioner only

15. Labelling of medicine under Schedule H1 (other than covered under narcotics) (Rule 97 (e))

If it contains a drug substance specified in Schedule H1, be labelled with symbol Rx, which shall be in red and conspicuously displayed on the left top comer of the label and shall also be labelled with the following words in legible black coloured font size in completely red rectangular box: SCHEDULE HI PRESCRIPTION DRUG – CAUTION

• • It is dangerous to take this preparation except in accordance with the medical advice.
  • Not to be sold by retail without the prescription of a Registered Medical Practitioner.

16. Labelling of medicine under Schedule H1 (under narcotics) (Rule 97 (e))

If it contains a drug substance specified in Schedule H1 and comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 be labelled with symbol NRx, which shall be in red and conspicuously displayed on the left top comer of the label and shall also be labelled with the following words in legible black coloured font size in completely red rectangular box: SCHEDULE H1 PRESCRIPTION DRUG – CAUTION

• • It is dangerous to take this preparation except in accordance with the medical advice.
  • Not to be sold by retail without the prescription of a Registered Medical Practitioner.

17. Labelling of Non-Sterile Surgical Ligature and Suture (Rule 102)

Every container of and wrapper enclosing surgical ligature or suture other than a ligature or suture offered or intended to be offered for sale as sterile, shall bear a label on which are printed or written in a conspicuous manner in indelible red ink the words “Non-sterile surgical ligature (suture)—not to be used for operations upon the human body unless efficiently sterilized”

18. Labelling of Patent or Proprietary medicine (Rule 103)

1. 1. The name and address of the manufacturer shall be printed on the label of the container of a patent or proprietary medicine.
   2. The true formula or list of the ingredients shall be printed or written in indelible ink on the outer label of every package containing patent or proprietary medicine.
   3. The name and address of the manufacturer shall be printed on the label of the container of a patent or proprietary medicine.
   4. The true formula or list of the ingredients shall be printed or written in indelible ink on the outer label of every package containing patent or proprietary medicine.

19. Use of letters I.F., etc (Rule 104)

Letters T.P., and recognised abbreviations of pharmacopoeias and official compendia of drug standards prescribed under these rules shall be entered on the label of the drug only for the purpose of indicating that the drug is in accordance with standards set out in the Indian Pharmacopoeia or in any such pharmacopoeia or official compendium of drug standards recognised

20. Prohibition against altering inscriptions on containers, labels or wrappers of drug (Rule 104A)

No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any drug: Provided that nothing in this rule shall apply to any alteration, any inscription or mark made on the container, label or wrapper of any drug at the instance or direction or with the permission of the licensing authority

21. Packing of drugs other than Schedule X (Rule 105)

Drugs meant for retail sale must be packed in sizes as per Schedule PI. If a drug is not listed there, the following apply: Tablets or capsules under 10 units must be in full numbers; above 10 must be in multiples of 5 or 7. Liquid oral preparations should be in 30 ml (paediatric), 60 ml, 100 ml, 200 ml, or 450 ml packs. Paediatric oral drops must be packed in 5 ml, 10 ml, or 15 ml; eye/ear/nasal drops in 3 ml, 5 ml, or 10 ml; eye ointments in 3 gm, 5 gm, or 10 gm. These rules don’t apply to: unlisted dosage forms, imported drugs, veterinary or export formulations, vitamins/tonics/cough syrups/antacids/laxatives in liquid oral form, unit doses (including applicaps), hospital/RMP/nursing home supplies, physician’s samples, and large volume IV fluids. New drug pack sizes not listed will require specific approval. Oxytocin injections must be in single-unit blister packs; Diclofenac injections for human use must be in single-unit dose packs.

22. Packing of drugs under Schedule X (Rule 105A)

Drugs listed in Schedule X must be sold in limited pack sizes:

1. 1. Tablets/Capsules: max 100 units
   2. Oral liquids: max 300 ml
   3. Injections: max 5 ml

However, this limit does not apply to drugs packed specifically for hospitals or dispensaries, if- packs are supplied directly by the manufacturer or distributor to the hospital/dispensary, and these hospital packs are not given to retail shops or individual doctors.

23. Drugs must not claim to cure certain diseases or cause miscarriage (Rule 106)

No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure, one or more of the diseases or ailments specified in Schedule J. No drug may purport or claim to procure or assist to procure, or may convey to the intending user thereof any idea that it may procure or assist to procure, miscarriage in women.