The Drug Controller General of India (DCGI) plans to ensure that antimicrobial drugs in Schedules H and H1 are properly labelled and sold only on prescription, while drugmakers and pharmacies continue to flout the rules.
Antimicrobials, which are used to prevent and treat infectious diseases in humans, animals and plants, include antibiotics, antivirals, antifungals and antiparasitics.
Incorrect or excessive use of these medications can lead to the development of antimicrobial resistance, which is difficult to treat and causes more infections.
One of the main causes of antimicrobial resistance
In India, these drugs can be freely purchased without a prescription in the absence of any regulation, a major cause of antimicrobial resistance (AMR).
The regulator is also planning to introduce a new provision under the Drugs and Cosmetics Regulations Act, 1945 for manufacturing blue coloured strips for antimicrobials to be placed on drug labels for identification.
The plan leaves the question of enforcement to state drug regulators, who collect drug samples from pharmacies and manufacturers to check whether the rules are being implemented or not.
“The government is taking the challenges posed by antimicrobial resistance caused by overuse of antibiotics very seriously. To curb antimicrobial resistance, the plan is to initiate uniform implementation of drugs in schedules H and H1 by state drug controllers through enforcement activities. Another plan is to insert a new rule in the Drugs and Cosmetics Act and Regulation for manufacturing of blue coloured strips for antimicrobials,” said a government official privy to the matter.
The supply of a drug specified in Schedule H1 is recorded in a separate register at the time of supply and such records are retained for three years and are open to inspection. The Central Drugs Standard Control Organisation (CDSCO) has included 24 antimicrobials in Schedule H1.
Another reason for the rise in AMR is that antimicrobials are also widely used in industries such as food, beverage and other non-medical sectors, the official said.
The official also said that certain modifications could also be implemented in the licensing conditions for the sale and manufacture of antimicrobials under the Drugs Regulations, 1945.
Queries sent to the spokesperson of the Ministry of Health went unanswered.
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