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New labelling norms for scheduled drugs !

New labelling norms for scheduled drugs !

The Union health and family welfare ministry has come out with Drugs and Cosmetics (Ninth Amendment) Rules, 2019 notifying implementation of new labelling norms for Schedule G, H, H1 and X drugs from April 1, 2019.

As per the amended rules notified by the ministry on March 20, 2019, rule 97A shall be inserted in the Drugs and Cosmetics Rules, 1945, after rule 97 which reads “Notwithstanding anything contained in rules 96 and 97, the modified or additional requirements of labelling as may be specified in the notification of the government of India in the ministry of health and family welfare number G.S.R. 408(E), dated April 26, 2018, shall be on voluntary basis for a period commencing on the date of coming into force on this rule and ending on March 31, 2019, and thereafter shall be mandatory.” 

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.

The ministry had on December 7, 2018 issued a draft notification extending deadline of the implementation of labelling norms for Schedule G, H, H1 and X drugs to April 1, 2019.

Earlier on April 26, 2018, the ministry had come out with a draft notification vide gazette notification no G.S.R. 408(E) mandating the drug manufacturers to print box warning/caution in red colour on Schedule G, H, H1, X drugs with legible black coloured font with effect from November 1, 2018. 

As per the draft, for norms, under rule 96, in sub-rule (1), of clause (xi), the label of the inner most container will bear a caution or warning. 

The draft further says, the warning on drugs covered under Schedule G or Schedule H or Schedule H1 or Schedule X, specified in rule 97 will be in legible black coloured font size in a completely red rectangular box. These drugs will be narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemic, antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer.

Reference: Pharmabiz.com

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