Draft labelling rules for prescription drugs unveiled

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New Delhi: Antibiotics and other prescription drugs must come in packages with warnings printed inside a red rectangular box, the health ministry has suggested in its latest labelling rules aimed at checking antimicrobial drug resistance in India.

Prescription drugs are those that require a medical prescription to be dispensed, unlike over-the-counter drugs.

The ministry had earlier proposed a conspicuous red vertical band running throughout the body of the package with the words “schedule drug” printed on it. However, the regulatory body on drugs and devices—the Central Drugs Standard Control Organisation (CDSCO)—put out a draft notification on its website on Monday with new labelling rules seeking comments and suggestions from stakeholders.

According to the draft, the new rules will apply to antibiotics, anti-diabetic drugs, corticosteroids, hormones, anti cancer drugs, narcotic analgesics, hypnotics, sedatives, painkillers, sedatives, tranquillizers, antiepileptics, antidepressants, anticoagulants and all other drugs that fall under Schedules G, H, H1 or X. Each schedule represents a different level of restriction.

The move reflects concern over widespread abuse of antibiotics that has contributed to the emergence of multi-drug-resistant bacteria in the country.

For Schedule H1 drugs, which cover key antibiotics and already carry the vertical red band, manufacturers will have to carry a message, “It is dangerous to take this preparation except in accordance with the medical advice. Not to be sold by retail without the prescription of a registered medical practitioner.”

Chinu Srinivasan from All India Drugs Action Network said, “This will probably be helpful to the drug inspectors. It will not make any difference for the run of the mill consumer. It will not end sale of over-the-counter drugs”.

Schedule G drugs are mainly hormone-based preparations and need to be taken under a doctor’s supervision.

As per the new draft rule, if drug substance in Schedule G is contained, the label should carry a caution “It is dangerous to take this preparation except under medical supervision” in legible black coloured font size in red rectangular box.

Medicines under the other schedules are not supposed to be sold over the counter and can be sold only through a prescription. Drugs under Schedule H can be sold only based on the prescription of a registered medical practitioner and only the amount specified in the prescription should be sold.

As per the new draft rules, the drugs under Schedule H be labelled with “symbol Rx and conspicuously displayed on the left top corner of the label and shall also be labelled with the following words in legible black coloured font size in completely red rectangular: ‘Not to be sold by the retail without the prescription of a registered medical practitioner’.”

The draft rule says that if a medicine contains a drug substance specified in Schedule H and comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) it should be labelled with symbol NRx which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labelled with the same words as prescribed for Schedule H drugs in legible black coloured font size and in red rectangular box.

For the Schedule X drugs, retailers have to maintain the copy of prescription for two years and the drugs should be labelled with the symbol ‘XRx’ and conspicuously displayed on the left top corner of the label. Schedule X includes narcotic and psychotropic substances-based drugs, reads the draft rules.

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