India’s apex drug regulator to crack the whip on manufacturers and pharmacies for not following antimicrobial drugs rule

The Drug Controllers General of India (DCGI) plans to ensure that Schedule H & H1 antimicrobial drugs are properly labelled and are sold only under prescription, as drug makers and pharmacies continue to flout rules.

Antimicrobials, which are used to prevent and treat infectious diseases in humans, animals and plants, include antibiotics, antivirals, antifungals and antiparasitics. 

Wrong or over-use of these medicines can lead to the emergence of anti-microbial resistance, which is hard to treat and cause further infections.  

A leading cause of anti-microbial resistance

In India, these drugs can be freely purchased over the counter without a doctor’s prescription in the absence of enforcement of regulation – a leading cause of anti-microbial resistance (AMR).

The regulator also plans to introduce a new provision under the Drugs and Cosmetics Act and Rules, 1945 for manufacturing blue colour strips for antimicrobials which go on the labels of the medicines for identification.

The plan leaves the matter of enforcement to state drug controllers, which collect drug samples from pharmacies and manufacturers to verify if the rules are being implemented or not.

“The government is very serious about challenges posed by antimicrobial resistance caused by the overuse of antibiotics. To curb AMR, the plan is to initiate uniform implementation of Schedule H & H1 drugs by state drugs controllers through enforcement activities. Another plan is to insert a new Rule under Drugs and Cosmetics Act and Rules, for manufacturing Blue colour strips for antimicrobials,” a government official aware of the matter said.

The supply of a drug specified in Schedule H1 are recorded in a separate register at the time of supply and such records are maintained for three years and open for inspection. The Central Drugs Standard Control Organization (CDSCO) has placed 24 antimicrobials under schedule H1.

Another reason for increasing AMR is that antimicrobials are also widely used in industries such as food, beverages and other non-medicinal sectors, the official said.

The official also said that certain amendment may also take plan in the conditioning of license for the sale and manufacturing of antimicrobials as per drugs rule, 1945. 

Queries sent to the health ministry spokesperson remained unanswered.