UPDATES ON THE AMENDMENTS MADE ON THE DRUGS AND COSMETICS RULE 1945 (AMENDMENT RULES 2018) ON LABELING OF MEDICINES RULES 96 & 97
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ABOUT AUTHORS
Godiyal Shrikant*, Panwar Sonu, Singh Lucky
Regulatory Affairs Department, Tirupati Medicare Limited, Paonta Sahib, HP, India
ABSTRACT:
Context: To update the amendments made in Gazette Notification for changes in the Manner of Labeling of Medicine as specified in Rule 96 & 97, which shall be required to be displayed on the inner most container and every outer in which the medicines are packed on the basis of Pharmacological Category of the product under which it falls. The label of OTC medicines plays an important role in conveying valuable information to the patient for safe and effective use of OTC.
Objective: The study was conducted to evaluate the labelling of OTC drugs in India as per the guidelines of US FDA. Objective: To prepare label of the medicines as per the mandatory information to be displayed on the label of the container so that the text matter on the label is clear, readable as shall fulfill the necessary requirements of Drug & cosmetic Act.