Packing and Labelling of Drug Formulations

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Chapter: Forensic Pharmacy : The Drugs and Cosmetics Act (DCA) 1940 and Rules 1945

Different steps in the manufacturing of drugs are suitably monitored by way of provisions made under DCA and Rules.

Packing and Labelling of Drug Formulations

Different steps in the manufacturing of drugs are suitably monitored by way of provisions made under DCA and Rules. The stages involved from procurement of raw material to the sale of drug formulations at the retail counters are mandatorily controlled in accordance with the provisions of the Act. In addition to mandatory requirement, it is also the moral, ethical and social responsibility of the manufacturer to ensure that the consumer receives good quality of his/her products. Packing is a blend of art and science with regulatory flavour. It is not sufficient to provide artistic packaging of the formulations but, it should be sufficient enough to ensure the stability of product during transportation and storage, assuring high quality of the product.

The text of labelling on packing material varies with the type of product formulated. There are specific requirements of labelling for drugs of Schedules G, H and X; external applications, patent and proprietary medicines, opthalmic ointments, contraceptives, disinfectants and several other drug formulations.

Labelling should be attractive and readable. It should be in printed form on the outerside of the packing material, as well as, on the packing of drug formulation. Even single unit offormulation (ampoule or tablet) should have appropriate label on it. In case of single dose of tablet, it could be short name of the product embossed on it.

The following particulars should appear in the label of the drug formulation.

1.        Name (Patent or Proprietary and Generic name)

2.        Name and address of manufacturer

3.        Batch or lot number

4.        Date of manufacturing

5.        Expiry date, if any

6.        Information for storage, if any

7.        Precautionary information - i.e., care in handling the product, use, etc.

8.        General information including - Physicians sample - not to be sold, in case of, physicians.

In case of medicines made up ready for treatment, name and address of licensee by whom it is "Supplied should appear on the label.

In case of preparations included in B.P, B.P.C, I.P the abbreviations should be mentioned.

In a preparatron containing more than 3% alcohol, the percentage of alcohol should be mentioned on the label.

Particulars of Label

The label should be printed or written in indelible ink and should clearly appear on label of inner most container and every other covering of the container. The details of labelling include-

1. Name ofthe drug (Trade name/Generic name as applicable) should be printed clearly.

2. Net contents (weight, measure, volume or number of units of activity as applicable). Net content should be in metric system.

3. Contents of active ingredients:

(a) For solid oral dosage forms (tablet, capsule), content in each unit of formulation.

(b) Solid form for injectables, in terms of weight mg/gm of powder. In case antibiotic, it is in terms of units of activity.

(c) Liquid orals: contents of ingredients in single dose of5 ml or multiple. If dose is less, the contents of ingredients in 1 ml of preparation.

(d) Liquid parentral preparation: contents of ingredients in I ml or per dose in case of single dose preparation.

4. Name and address of the manufacturer on small container. Name and place of manufacture is sufficient on each ampoule

5. Manufacturing licence number abbreviated as Mfg. Lic. No.

6. Distinctive Batch No. should be written as Batch No. or B.No. or Batch, Lot No.

7. Date of manufacturing.

8. Expiry particulars, ifany.

9. Precautions related to handling, use or distribution.

10. Information on storage.

11. Any other general information or specific information pertaining to formulation. If the sample is for physician, the words "Physicians sample - not for sale" should be printed.

For Schedules F and F (I) and X drugs, only Code No. as approved by the Licensing Authority is required to be printed.

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