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Regular-article-logo Tuesday, 15 April 2025

Red line on medicines

Plan to check misuse of prescription drugs

G.S. MUDUR Published 23.10.16, 12:00 AM
Red vertical band on a drug packet 

New Delhi, Oct. 22: The Union health ministry plans to make a 5mm-thick red vertical band mandatory on packets of prescription-only drugs to sensitise people to be cautious while buying these medicines that are widely sold without prescriptions.

A proposed notification says the labels on the innermost containers of such drugs and all other packaging shall "bear a conspicuous red vertical band on the left side running throughout the body of the label" with the words "schedule drug" overprinted on the band.

Senior health officials and drug regulators say the new rule will apply to antibiotics, anti-cancer drugs, anti-diabetic drugs, corticosteroids, hormones, narcotic painkillers, sedatives, tranquillisers and all other drugs that fall under Schedules G, H, H1 or X.

Each schedule represents a different level of restriction. Schedule G drugs are mainly hormone-based preparations and need to be taken under a doctor's supervision. Medicines under the other schedules are not supposed to be sold without prescriptions. Retail chemists are expected to preserve prescriptions for schedule X drugs - narcotic and psychotropic medicines - for two years after the sale. Schedule H1 drugs, which cover key antibiotics, already carry the vertical red band.

"We want to extend the red band to all schedule drugs so people become aware that these are special drugs that need to be taken with great care - neither overused nor underused," a health ministry official said.

The ministry had published its proposed notification on August 12, allowing 45 days for responses from the public or industry. Sections of doctors concerned about the prescription-less sales of schedule drugs say the ministry has not received objections during the stipulated period.

The health ministry official said a final notification was due soon. The move comes amid concerns that a widespread abuse of antibiotics has contributed to the emergence of multi-drug-resistant bacteria that are hard to treat with most available antibiotics.

In 2013, the health ministry had notified new rules for third and fourth-generation antibiotics that required the names of the buyers and the amounts they bought to be recorded in retail pharmacy registers for three years. But officials concede the rules are poorly implemented.

"The red band will be a message to the public and pharmacists," said Vadlamudi V.S.V. Rao, president of the Indian Pharmaceutical Association.

Rao is a member of the technical advisory board that advises the Central Drugs Standard Control Organisation, a regulatory agency.

Health officials hope the band will serve as a symbol of caution to people who approach retail chemists for medication.

Experts say that retail chemists have been known to give antibiotics to patients for various symptoms.

Researchers tracking antibiotic resistance patterns in India see the red band as only a small step that could complement more challenging measures that need to be taken to curb the misuse of schedule drugs, particularly antibiotics.

Senior doctors say it is not just patients and pharmacists who abuse schedule drugs. Health-care institutions need to establish antibiotic policies - a system to regularly monitor the type of bacteria circulating in the health-care institution - that will minimise trial and error when treating patients and curb resistance.

Clinical microbiologists point out that only a small fraction of India's hospitals and nursing homes actually implement antibiotic policies.

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