Labeling of Cautionary Note under Rule of 97 of Drug & Cosmetic Act – (No. DCGI/MISC/572012)

Rule 97 of Drug & Cosmetics Act 1945, provides for printing caution/ Warning in respect of drugs covered under Schedule H, Schedule G and substance covered under the purview of Narcotic & Psychotropic drugs Act, 1985 for the information of patients, doctors pharmacists and others so that there is no misuse of these drugs. It is observed that the caution does not appear in conspicuous manner on the innermost label of these drugs. This leads to unethical use of these medicines by the patients because of difficulty in reading/noticing the cautionary note provided on the label.

Hence all the manufacturers are requested to provide the caution / warning notice on the label in conspicuous manner to attract the attention.