Antimicrobial Resistance India: An expert committee constituted under India’s top drug regulator has recommended changes in the existing rules to stop advertisements of prescription-only and high-risk medicines. In a meeting held last month, the Drug Consultative Committee of the Central Drugs Standards Control Organization (CDSCO) had expressed serious concern over the increasing and largely uncontrolled promotion of drugs on digital platforms. These medicines include life-saving injectables, antibiotics, hormonal therapy, psychotropic medicines, cancer treatment and narcotics.

Which medicines are banned without approval?

According to an India Today report, current drug-license conditions already prohibit advertising of drugs listed in Schedules H, H1 and A CDSCO official said that this rule does not clearly cover licensees selling or distributing medicines and this lacuna is being taken advantage of by marketers.

Increasing advertisements on social media

The matter has become more serious on e-pharmacy platforms. State regulators have repeatedly complained that many platforms are promoting prescription-only drugs at steep discounts to lure customers. According to officials, such promotions have also increased rapidly on social media channels, worsening problems such as antibiotic misuse and self-medication, which are already serious public-health challenges.

Now sending such promotional messages without asking

Recently, there have been complaints of promotional text messages for new GLP-1 weight-loss drugs such as Monzaro and Vegovy, even though these drugs should only be given on prescription by a specialist doctor.

CDSCO approval mandatory

To curb the increasing misuse of antibiotics, CDSCO is considering making its approval mandatory for every new antibiotic, even those with active ingredients already approved, before its launch in India. This step is being taken at a time when concerns about antimicrobial resistance are increasing both in the country and the world. The expert panel has also suggested that all antimicrobial drugs be brought under the definition of new drug as per the New Drugs and Clinical Trials Rules, 2019. This means that every antibiotic, even if previously approved, may have to obtain CDSCO approval before manufacturing and marketing.

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Disclaimer: This information is based on research studies and expert opinion. Do not consider this as a substitute for medical advice. Before adopting any new activity or exercise, please consult your doctor or relevant specialist.

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