DCGI issues direction to make labelling of cautionary note on drugs more stringent
The Drug Controller General of India (DCGI) has asked the State drug controllers to take steps to ensure that the drug manufacturers display the caution/warning in a prominent way in compliance with the Rule 97 of the Drugs and Cosmetic (D&C) Rules and thus reduce the misuse of the drugs.
The direction comes in the wake of several instances of the manufactures overlooking the rules in this regard while printing cautionary note on drugs under Schedule H and Schedule G.
“Rule 97 of the Drugs and Cosmetic Rules, 1945 provides for printing of caution/warning in respect of drugs covered Schedule H, Schedule G or substances coming under the purview of Narcotic Drugs and Psychotropic Drugs Act, 1985 for the information of patients, doctors, pharmacists and others so that there is no misuse of these drugs,” the letter by the DCGI said.
“It is however observed that in many cases the caution does not appear in a conspicuous manner on the inner most labels of these drugs and is overlooked by the consumers as well as other persons handling the drug. This leads to unethical use of these medicines by the patients because of difficulty in reading and noticing the cautionary note provided on the label,” the DCGI said.
He has asked the State drug controllers to direct the manufacturers under their respective jurisdiction to go by the rules while labelling medicines with cautionary warnings and provide caution in a conspicuous manner to attract attention.
“This would help in safeguarding and enhancing public health by assuring proper use of medicines in accordance to the cautions printed on the label,” the letter said.