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Labelling of packaging of drug
The labelling of packaging for drugs serves multiple objectives and holds significant importance in the pharmaceutical industry. It not only provides essential information to healthcare professionals and patients but also ensures compliance with regulatory requirements. In this section, we will explore the objectives, importance, and types of labelling used in drug packaging.
Labelling means, containers of all drugs and medicines are to be labelled according to drug and cosmetics act & rules 1945. It should be printed on inner and outermost container of any drugs.
The term labelling designates all labels and other written printed or graphic matter upon an immediate container of an article or upon, or in any package or wrapper in which it is enclosed except any outer shipping container.
Function of label
1. For information of the product.
2. Provide ingredients.
3. Purpose/use of the product.
4. Child safety
5. Other information like batch no, price & etc.
Labelling in India
All labels of a drug should confirm as per the specification under the drug & cosmetic rules 1945. That no person sells or distribute any drug unless it is labelled in accordance with the rules.
It also includes information’s:
1. Indications, effects, dosage form
2. Duration of administration
3. Warnings
4. Hazards
5. Contraindications
6. Side effects
7. Precautions & relevant information
Objectives of labelling
The primary objective of drug labelling is to convey critical information about the medication to healthcare professionals and patients. This includes details such as the name of the drug, dosing instructions, active ingredients, warnings, precautions, and storage conditions. Clear and accurate Labelling plays a crucial role in preventing medication errors, ensuring patient safety, and promoting proper usage.
FDA requires that drug labelling be balanced and not misleading the label must be scientifically accurate and provide clear instruction to health care practitioner for prescription drugs & consumer for over-the-counter drugs and supplements.
1. Brand identification
Labelling helps in the identification and principal place of business of the person by or for whom the prepackaged product was manufactured, processed, product or packaged for resale.
2. Description
Labels provide the information regarding the pharmaceuticals, it describes the composition, batch no, cost, mfg. date & expiry date.
3. Promotion
Finally labels helps in promoting the product through attractive and bright graphics replacing paper labels glued on bottles.
Importance of labelling
Drug packaging labels are subject to strict regulatory guidelines enforced by health authorities worldwide. These regulations aim to standardize labelling practices for consistency across countries and ensure that vital information is readily available for all stakeholders involved in the healthcare ecosystem.
The rate use of all medicine depends on the user, reading the labelling & packing carefully and accurately and being able to assemble and act on the information presented.
All labels must be clear, concise and must bear all necessary information regarding the safe use of a product.
Manufacture label
Dispensing label