ASSESSMENT OF COMPLIANCE OF DRUG LABELS IN INDIA WITH ‘THE DRUGS AND COSMETIC ACT AND RULES’ GUIDELINES

Ashok Kumar Sharma and Amol Khanapure*

ABSTRACT

Background: Information mentioned on innermost container of a drug is most important for the dispenser as well as consumer. The Drugs and Cosmetic Act and Rules mention guidelines for labelling of innermost container of drugs but it has been observed that the compliance to these is often low. Since there are only few studies available to assess the compliance with these guidelines, the present study was planned. Materials and Methods: A total of 100 dosage forms from various categories were randomly collected from drug selling / dispensing units or physicians and included in the study for assessment of compliance of their labels with the guidelines mentioned in „The Drugs and Cosmetic Act and Rules‟. Results: Proper name was more conspicuous than trade name in 14.82% non-generic preparations; while trade name was under and after proper name in 96.3% in these preparations. Pharmacopoeia name was present in 88% preparations; while correct statement of net contents was mentioned in 69% preparations. Red vertical line was observed in 97.40% preparations. Preparations containing Schedule G drug had compliance for „Caution‟ as 100%. Preparations containing Schedule H drug had compliance for symbol „Rx‟ as 77.65% and for warning as 98.82%. Preparations containing Schedule H1 drug had compliance for „Rx‟ in red and warning in red box as 100%. Other particulars with 100% compliance were content of active ingredients, name and address of the manufacturer, batch number, manufacturing licence number, date of manufacture and expiry, „Physician‟s sample- Not to be sold‟ on preparations which were Physician‟s sample and „FOR EXTERNAL USE ONLY‟ on preparations meant for external application. Conclusion: From the above findings, it may be concluded that majority of drug labels were not compliant with the guidelines given by The Drugs and Cosmetic Act and Rules. Strict adherence is necessary to ensure safe, effective and rational use of medicines.

Keywords: Drug labels, The Drugs and Cosmetic Act and Rules, Compliance.