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Labeling and packaging of Drugs as per Drugs and Cosmetic Act

Labeling & Packaging

All the general and specific labeling and packaging specified to all classes of drugs and cosmetics should be as per the provisions made under the act.

Labeling in India

All labels of a drug should conform as per the specifications under the Drugs and Cosmetics Rules 1945.

Ø That no person sell or distribute any drug unless it is labeled in accordance with the Rules (Rule 95 of D&C Act).

Labeling – is the norm in this context that provide comprehensive and concise statement of a drug’s Quality Safety and Efficacy.

– it includes information regarding indications, effects, dosage form, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions and other relevant information.

Importance of labeling

The safe use of all medicines depends on users reading the labeling and packaging carefully and accurately and being able to assimilate and act on the information presented.

All labels must be clear and concise and must bear all necessary information regarding the safe use of a product.

Prescription Drug Labeling

These cannot be used safely by consumers without the diagnosis and supervision of a physician.
These have unavoidably adverse effects, but the benefits of using such drugs outweigh the accompanying risks.
It is the expert judgment of a practitioner to decide the use of a drugs for a particular patient.
Thus, the manufacturer of a prescription drug is required to provide adequate labeling for practitioners to be able to administer or dispense the drug safely and for the purposes for which it is intended.

Components of Labeling

The prescription drug labeling consists of following components:-

Ø Container/ Carton Label

Ø Package Insert

Regulatory Requirements for Label :-

Rule 96 of the Drug and Cosmetic Rules (manner of labelling) mandates the minimum information which needs to be put on the label of all medicines.

Misbranded drug if it is not labelled in the prescribed manner as in drug and cosmetic rules(chapter 3 section 9(b) of D&C act).
The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering which the container is packed, namely :-

1. Name of the drug:-

For drug included in the schedule F /F(1), the name given therein.
For drugs included in the Indian Pharmacopoeia or the official pharmacopoeia and official compendia of drug standards prescribed in the rule 124, the name or synonym specified in the respective followed by letters ‘I.P.’
It 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.
for drugs included in the National Formulary of India, the name or synonym specified therein followed by the letters ‘N.F.I.’

2. Net Quantity of contents

3. The content of active ingredients

4. Name and Address of manufacturer

5. Batch or lot number(Batch No.)

6. Manufacturing license number (“Mfg. Lic. No.”)

7. Import License No. (if applicable):- the no. of license under which the drug is imported, preceded by words “Import Lic. No.”

8. Manufacturing date, Expiry date and Storage conditions

9. Other Specific Requirements

Physician Sample – ‘Not to be sold’.
Alcohol content

Package Inserts

The Package insert is considered “adequate direction for use”.
It is also directed to healthcare professional and help him in making correct decision regarding the prescribing of drug to a particular patient.
In India, it is governed by the ‘Drugs and Cosmetics Act(1940) and Rules(1945)’ .Schedule D 11 (section 6) of the rules including the heading to which information to be provided in the Package Inserts.
It is divided into two parts:

– Therapeutic indications

– Pharmaceutical information

Drug Labeling Regulation in India

Rule 97 requires specific caution statements to be present on label for the different drug schedules.

Prescription drugs in India are those that fall under two schedules of the Drug and Cosmetics Rules, 1945 :

– Schedule H

– Schedule X

But drugs falling under Schedule G require the following mandatory text on the label: “Caution: It is dangerous to take this preparation except under medical supervision”.

For Allopathy

For Ayurvedic, Siddha, Unani, Homoepathy and Cosmetics

Frequently Asked Questions (FAQs)

What are the key components of drug labeling as per the Drugs and Cosmetics Act?
- The key components include drug name, dosage strength, route of administration, batch number, manufacturing date, expiry date, storage conditions, warnings, and manufacturer’s details.
Why is proper drug packaging important?
- Proper drug packaging protects medications from environmental factors, ensuring their stability and efficacy.
How do regulatory authorities enforce drug labeling requirements?
- Regulatory authorities monitor and inspect pharmaceutical companies to ensure compliance with labeling standards, and non-compliance can lead to penalties.
What role does Good Manufacturing Practices (GMP) play in drug labeling and packaging?
- GMP ensures that drugs are consistently produced and controlled according to quality standards, including labeling and packaging.
What are some future trends in drug labeling and packaging?
- Future trends include increased use of technology, sustainable packaging materials, and innovations like QR codes for easy access to medication information.