The Drug Controllers General of India (DCGI) wants to ensure that Schedule H and H1 antimicrobial drugs are properly labelled and sold only on prescription as drugmakers and pharmacies continue to flout the rules.
Antimicrobials are used to prevent and treat infectious diseases in humans, animals and plants. They include antibiotics, antivirals, antifungals and antiparasitics.
Misuse or overuse of these medications can lead to the development of antimicrobial resistance, which is difficult to treat and can lead to further infections.
A major cause of antimicrobial resistance
In India, these drugs can be bought freely without a doctor's prescription because there is no enforcement of regulations. This is a major cause of antimicrobial resistance (AMR).
The regulator is also planning to introduce a new provision under the Drugs and Cosmetics Act and Rules, 1945 for the manufacture of blue strips for antimicrobial agents. These strips will be placed on the labels of medicines for identification.
The plan leaves enforcement to state drug regulators, who collect drug samples from pharmacies and manufacturers to monitor compliance.
“The government is very serious about the challenges posed by antimicrobial resistance caused by overuse of antibiotics. To curb AMR, the plan is to initiate uniform implementation of Schedule H & H1 drugs by state drug controllers through enforcement activities. Another plan is to bring in a new rule under Drugs and Cosmetics Act and Rules, for the production of blue colour strips for antimicrobials,” said a government official aware of 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 maintained for three years and are open for inspection. The Central Drugs Standard Control Organisation (CDSCO) has placed 24 antimicrobial agents under Schedule H1.
Another reason for the rise in AMR is that antimicrobials are also widely used in sectors such as food and beverage and other non-medical sectors, the official said.
The official also said that there may also be changes to the conditions for licensing the sale and production of antimicrobials, under the 1945 Medicines Regulations.
Questions sent to the spokesperson of the Ministry of Health remained unanswered.
