The document discusses the importance of drug labeling and packaging. Correct and clear labeling is important for patient safety and proper drug dispensing. Packaging helps maintain drug quality by providing protection from physical damage, biological degradation, light, water and other substances. Regulations require that all labels and packaging conform to specifications and are designed to maintain stability and integrity of products.
The document discusses the importance of drug labeling and packaging. Correct and clear labeling is important for patient safety and proper drug dispensing. Packaging helps maintain drug quality by providing protection from physical damage, biological degradation, light, water and other substances. Regulations require that all labels and packaging conform to specifications and are designed to maintain stability and integrity of products.
The document discusses the importance of drug labeling and packaging. Correct and clear labeling is important for patient safety and proper drug dispensing. Packaging helps maintain drug quality by providing protection from physical damage, biological degradation, light, water and other substances. Regulations require that all labels and packaging conform to specifications and are designed to maintain stability and integrity of products.
Labelling:- Label means a display of written, printed or graphic
matter upon immediate container or the wrapper of a drug package. And drug labelling is referred to as prescription labelling, is written, printed or graphic matter upon any of its container, or accompanying such a drug.
Packaging:- Packaging of drugs can be defined as the
economical means of providing presentation, protection, compliance, information, integrity and stability of the product.
Labelling and Packaging of Drugs (rules & regulations):-
All lebels of a drug should conform as per the specificarions under the Drug and Rosmetics Rules 1945.
Packaging of drugs should be done as specified in Drugs and
Cosmetic Act 1940. Importance of Labelling:- Correct drug labelling is central for ensuring proper drug dispensing and thus for patient safety. Labelling errors may result in adverse health outcomes.tical
Importance of Packaging:- Packaging is essential to maintain
the quality of the drug. Packaging protects the drug not only from physical damage but also from biological degradation. Sensitive drugs need adequate protection from light, water and sometimes also proximity to other sensitive substances. SUMMARY/REPORT
Both lebelling and packaging plays important role in
pharmaceutical industry. Correct drug labelling is also very important for ensuring proper drug dispensing and thus for patient safety. The primary purpose of labeling of medicines is the clear unambiguous identification of the medicine and the conditions for its safe use. It is also an informative tool for stakeholders such as health-care professionals, patients and pharmacists. A drug label is required for marketing of any drug and it is a useful tool for pharmacoeconomic studies. The safe use of all medicines depends on accurate information on the label and users reading the label carefully and being able to assimilate and act on the information presented. A regulatory compliant drug label is mandatory for marketing of a drug, which should be in accordance with requirements given by regulators in respective country. Regulatory body of every country has a set of requirements for labeling of drugs. The criteria for drug labeling in India are listed in Drug and Cosmetic Rules (D and CRs) 1945 under Sections 96 and 97. Keeping those requirements under consideration, labels are designed by the manufacturers. On the other hand Proper packaging is essential to maintain the quality of the drug. The particular type of packaging used in pharmaceutical industries depends on the nature of the product they are intended for. The advantages of any packaging solution used should fit closely to the needs of the product it is carrying. Packaging of pharmaceuticals can be devided into three parts, (a) Primary packaging, (b) Secondary packaging (c) Tertiary packaging. Some of the common packages are:- blister packs, bottles, strip packs, sealed tubes, film wrapper, sachets, etc. Nowdays good packaging helps the manufacturer to attract customers. REFERENCE
I. Dr. Kuchekar B S, Textbook of Pharmaceutical
Jurisprudence, Nirali Prakashan, 16th edition, Page No:- 5.29-5.41 II. Sameer Rastogi, Singh Anita, Kumawat Kumar Mukesh, Pharmaceutical Jurisprudence, Nirali Prakashan, 9th edition, Page No:- 6.21-6.36 III. Dr. Kumar M, Garg Rajneesh, A textbook of Pharmaceutical Jurisprudence, SIA Publishers & Distributors pvt. Ltd., 13th edition, Page No:- 156-159 IV. Dr. Maniyar G. Mithun, Chakorkar S. Snehal, Chandak R. Priyanka, Pharmaceutical Jurisprudence, Technical Publications, 4th edition, Page No:- 242-248