Demonstrate the labelling of homoeopathic medicine according to Part IX of the Drugs & Cosmetic Act 1940

Part IX of the Drugs and Cosmetics Rules, 1945, under the Drugs and Cosmetics Act, 1940, specifically deals with the regulation and labelling of homeopathic medicines in India. Here are the key provisions and guidelines for labelling homeopathic medicines according to these regulations:

Key Provisions for Labelling Homeopathic Medicines -

1. Principal Display Panel

Name of the Medicine: The label must prominently display the name of the homeopathic medicine.
Potency: The potency of the homeopathic medicine must be indicated clearly, using standard notations like 6X, 30C, etc.

2. Manufacturer’s Details

Name and Address: The name and complete address of the manufacturer must be clearly stated on the label.
License Number: The manufacturing license number issued by the relevant authority must be displayed.

3. Batch Information

Batch Number: Each label must include the batch number of the product.
Manufacturing Date: The date of manufacture must be indicated on the label.
Expiry Date: The expiry date or best-before date must be clearly mentioned.

4. Composition

Ingredients: The label should list all the active ingredients used in the preparation of the medicine, along with their potencies.
Alcohol Content: If the medicine contains alcohol, the percentage of alcohol by volume must be stated.

5. Usage Instructions

Dosage and Directions: Clear instructions on the dosage and method of administration must be provided.
Indications: The therapeutic indications for which the medicine is recommended can be included, provided they are supported by homeopathic pharmacopoeias or literature.

6. Storage Conditions

Storage Instructions: The label must include instructions on how to store the medicine, such as “Store in a cool, dry place” or “Protect from light.”

7. Warnings and Precautions

Safety Information: Any necessary warnings, such as “Keep out of reach of children,” should be clearly stated.
Contraindications and Side Effects: If applicable, information on contraindications and potential side effects should be included.

Example of a Compliant Label for a Homeopathic Medicine -

Here's a hypothetical example of a compliant label for a homeopathic medicine:

—————————————————

# Front Label

Aconitum Napellus 30C

Manufactured by:
Homoeo Pharma Pvt. Ltd.
123, Health Street, Wellness City, India

License No: MH-12345

Batch No: AC123456
Manufacturing Date: 05/2024
Expiry Date: 05/2027

—————————————————

# Back Label

Composition:
Each 5 ml contains:
– Aconitum Napellus 30C

Alcohol Content: 15% v/v

Dosage and Directions for Use:
– Adults: 5 drops in a teaspoon of water, 3 times a day or as directed by the physician.
– Children: 2 drops in a teaspoon of water, 3 times a day or as directed by the physician.

Indications:
– For the relief of acute inflammation and feverish conditions.

Storage Conditions:
– Store in a cool, dry place.
– Protect from light.

Warnings and Precautions:
– Keep out of reach of children.
– If symptoms persist, consult a healthcare provider.

—————————————————

Compliance with Labelling Provisions -

Visibility and Legibility: The information on the label must be clearly printed and easily readable.
Accuracy: Ensure that all information provided is accurate and up-to-date, reflecting the true composition and manufacturing details of the medicine.
Regulatory Approval: Labels should comply with all regulatory guidelines as specified under the Drugs and Cosmetics Act and Rules, and any specific requirements from the licensing authority.