Labelling and Packaging of Drugs as per

Drugs and Cosmetic Act

Saloni AmbasanaPh.D. Scholar

PGT-SFCGujarat Ayurved University

INDIA

SIGNIFICANT LEGAL REQUIREMENTS FOR LABELLING DRUGS

Manufacturing date

Expiry date

For Schedule P & C drugs only.

Net contents by volume/ weight/ number

Potency, standard, grade, dose etc. expressed as millilitres, grains, units etc.

Precautions for handling, storage, sale/ usage etc.

Special requirements for specified drugs like physicians samples, veterinary drugs, drugs containing specific materials like spirit, colour etc.

Special provisions for dispensed drugs/ drugs for export.

Manufacturers name and addressLicense numberBatch number

Special provisions for dispensed drugs/ drugs for export.

Identity of the drug and its manufacturer, through its

official name, trade name, if any.

For Schedule W drugs only official names can be used

1.Drugs needing Cautionary Labelling.

2.Labelling requirements for other Drugs.

3.Labelling of Medicines for Export.

4.Labelling of Dispensed medicines.

Drugs ParticularsSchedule G “Caution: It is dangerous to take this preparation except under

medical supervision.”

Schedule H i. “Schedule H drug. Warning: To be sold on the prescription of a Registered Medical Practitioner only.”

ii.Symbol R prominently on left hand top corner of the label.iii.Symbol NR prominently on left hand top corner if drug is

covered under Narcotic Drugs & Psychotropic Substances Act.

Schedule X i. “Schedule X drug. Warning: To be sold on prescription of RMPs only.”

ii.Symbol XR in red on left hand top corner.

Schedule C i. Where a test for maximum toxicity is prescribed a statement that it has passed that test.

ii.Nature and percentage of antiseptic, if any.

Veterinary drugs i. ‘Not for human use. For animal treatment only.’ii.Head of any domestic animal.

DRUGS NEEDING CAUTIONARY LABELLING

Drugs ParticularsOphthalmic solutions/ suspensions/ ointments

i. Use within one month of opening. Not for injection.ii. Name and concentration of preservative.iii.Wordsa. If irritation persists or increases discontinue use and consult

physician. Keep container tightly closed.b. Do not touch dropper tip/ other dispensing tip to any surface

since this may contaminate. Before fixing dropper there is a possibility of touching it. Scrub hands with soap and rinse with water.

Ophthalmic ointments Warning: If irritation persists or increases discontinue use and consult physician.

LABELLING REQUIREMENTS FOR OTHER DRUGSPatent & Proprietary i. Names and quantities of active ingredients.

ii. If vitamins are present, the following words as the case may be –“For therapeutic use”“For prophylactic use”“For paediatric use” and age of child/ infant.

Medicines for external use/ medicines containing methylated spirit

“FOR EXTERNAL USE”In capitals

Mechanical contraceptives Particulars specified in Schedule R.

Disinfectants i. Grade and phenol coefficient.ii. Method of use

Alcoholic preparations % of Alcohol

Coloured preparations Name and percentage of colour.

LABELLING OF MEDCINIES FOR EXPORT

• No conditions.• Label should be in accordance with the provisions of labelling of the

country of export.

• However, must contain –1. Name2. Name and address of the manufacturer3. License no. and Batch no.4. Date of expiry

LABELLING OF DISPENSED MEDCINIES

• Medicines dispensed on prescription of RMPs are also exempted.

• But, following particulars to be included –a. Name and address of the supplierb. Name of the patient and quantityc. Serial no. in prescription recordd. Dose if its is for internal use and the words ‘FOR EXTERNAL USE

ONLY’ if it is for external application.

MANNER OF LABELLING • The particulars of the medicine should be labelled on the innermost container in which

medicine is kept in a conspicuous position.• And also one every subsequent container in which the container may be packed.

• If any transparent covering or wrapper or any covering is solely used for the purpose of packing for transport or delivery no need to label.

• Particulars may be printed on label which is attached/ painted/ otherwise indelibly marked on the container.

• The name of the drug should not be marked on any glass container except the ampoules.

• Proper name should be in red letters followed by trade name if any.

• The trade name should be in any letter other than red and in letters of similar size as proper name, except for veterinary, ear and eye drops and sterile products.

• When drug is packed in ampoule, it is necessary to label the ampoule itself with –i. Name and quantity of the drugii. Name of the manufacturer

• Other particulars may be labelled on the box or device in which the ampoules are kept.

• The letter I.P., B.P., or B.P.C., etc. to be entered to indicate that the drug compiles the standard said in the pharmacopoeias.

• Containers of H & G drugs, prior to manufacture in dosage forms, should be labelled in red letters against white background.

PACKAGING

• OPTHALMIC PREPARATIONS: -• Whether in liquid or ointment form must be packed in single and multiple dose

containers which are sterile + suitable substance to prevent growth of micro-organisms.

• The preparations must be packed in such containers and in such amounts as are likely to prevent contamination.

• Must be provided with cap droppers in sterile cellophane covers packed in polythene self dropping bottles or tubes.

• In packing not exceeding: -i. 100 unit doses – capsules/ tabletsii. 300 ml – liquid preparationsiii. 5 ml – injection

• But, for Hospitals or Dispensaries they can supply in packs other than specified.

• Packs meant for hospital cannot be supplied to retailers or registered medical practitioners.

LABELLING AND PACKAGING OF ASU DRUGS

1. Name of the drug as mentioned in literature (in 1st Schedule).

2. Net contents in terms of weight or volume in metric system.

3. No. of license under which the drug is manufactured preceded by the words Manufacturing License No. (Mfg. Lic. No. or M.L.)

4. “Batch” or “Lot No.” or any other distinguishing prefix.

5. Name and address of the manufacturer and address of the premises where manufactured.

6. Date of manufacture.

7. Words “Ayurvedic medicine”, “Siddha medicine” or “Unani medicine”, as the case may be.

8. The words “FOR EXTERNAL USE ONLY” if the medicine is meant for external application.

9. The words “Physician’s Sample. Not to be sold”, if drug is intended for free distribution to the members of the medical profession.

10.True list and quantities of all ingredients used in the manufacture and a reference to the method of preparation as detailed in the Standard text and Adikarana.The list of ingredients should be in normal course displayed on the label.But, in case it is too large to be accommodated, it should be printed and enclosed with packing and a reference to this effect made on the label.

11.Medicines containing any substance specified in Schedule E(1) should be labelled with the words.Caution: “To be taken under medical supervision” both in English in Hindi.

LABELLING FOR HOMEOPATHIC MEDICINES

1. Name of the medicine as specified in the homeopathic pharmacopoeias of U.S.A. or U.K. for drugs specified therein or a name descriptive of the true nature of a drug.Those with 2 or more ingredients their names, potency and proportion.

2. Potency in decimal, centesimal or millesimal systems.

3. Name and address of the manufacturer or in case a medicine is not sold in its original container the name and address of the seller.

4. % of alcohol. But, if the capacity of container is 30 ml no need.

5. “Homeopathic medicine”.

6. Manufacturing license no. preceded by the words “Mfg. No.” or “M.N.” and batch no. preceded by the words “Batch or Lot No. or Lot”.

7. Proprietary name, if any (no medicines containing a single ingredient can be labelled with such a name).

LABELLING AND PACKAGING FOR COSMETICS • Whether of Indian origin or imported from outside should be labelled as follows -

Class ParticularsIn general Name of the cosmetic and name and address of the manufacturer.

Manufacturing License No. preceded by the letter M and Batch no. preceded by the letter B if cosmetic is packed in containers having more than 10 gm.

Outer labels: -Net contents expressed as weights (solids and semi-solids) or volumes (liquids) or as numerical counts (if cosmetic is subdivided). If the cosmetic is not more than 60ml/ 30gm no need

Inner label: -Adequate directions for safe use; Warning or caution or special direction; names and quantities of ingredients that are hazardous.

Class ParticularsHair dyes containing dyes, colours and pigments

“Caution. This product contains ingredients which may cause skin irritation in certain cases and so a preliminary test accompanying directions should be made. This product should not be used for dyeing the eye-lashes or eye brows as such use may cause blindness.” (Equivalent labelling in local languages is also mandatory.)

Alcoholic fragrance solutions such as eau-de-cologne containing diethyl phthalate

The words - HARMFUL IF TAKEN INTERNALLY

Content of Diethyl phthalate in each ml.

Cosmetics for export Specific requirements if any.

Name and address of manufacturer and name of cosmetic or a code no. approved by the licensing authority.

Soaps containing hexachlorophene

Contains hexachlorophene; not to be used on babies.

Tooth pastes containing fluorides

Content of fluoride in ppm. (max. 1000 ppm)Date of expiry

• In case of Hair dye following instructions should be written in English as well as local language: -

“This preparation may cause serious inflammation of the skin in some cases and hence a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, clean a small area behind the ear or upon the inner surface of the forearm using either soap or water or alcohol. Apply a small quantity of the hair dye as prepared for use to the area gently with soap and water. If no irritation or inflammation is apparent it may be assumed that no hypersensitivity exists. The test should however be carried out before each and every application. The preparation should on no account be used for dyeing, eyebrows or eyelashes since severe inflammation of the eye or blindness may result.”

• Note: - If the cosmetic has only one label, all information of outer and inner one should be displayed on the label.

• Note: - No soap is permitted to contain more than 1 % hexachlorophene.