Taking a major step to prevent misuse of antibiotics or anti-microbial drugs in India, the central government has laid down some new rules for doctors and all medical associations. The move is intended to prevent misuse or drug abuse
The new guidelines regarding antibiotics have made it mandatory for doctors as well as all medical associations to write exact indications on their prescriptions while prescribing these drugs. The government has also asked all pharmacist associations in India to dispense antibiotics only on the prescription of a qualified doctor. In a letter on January 1, 2024, Director General of Health Services Dr Atul Goel stated that this move has been made to stop the misuse and overuse of anti-microbials, which are the key drivers in the development of drug-resistant pathogens.
Dr Goel wrote to all doctors of medical colleges and medical associations in the country urging them to adhere to the guidelines. “It is important that doctors mention the exact indication on their prescriptions while prescribing anti-microbials. It is an appeal to all doctors in medical colleges to mandatorily mention the exact indication, reason, or justification while prescribing antimicrobials,” Goel said.
The letter said that Under Drugs and Cosmetics Rules, 1945, antibiotics are included in the list of drugs specified under Schedule H and H1 which are required to be sold by retail on the prescription of a registered medical practitioner only.
To monitor the indiscriminate use of certain antibiotics and prevent the emerging threat of resistance to anti-microbial agents, the Union government, in 2014, issued the Schedule H and H1 notification. The notification was an amendment to the Drugs and Cosmetics Rules, 1945, the law regulating the import, production, sale, prescription, and use of medicines.
Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. The manufacture and sales of all drugs are covered under the Drugs and Cosmetics Act and Rules. It is revised at times based on the advice of the Drugs Technical Advisory Board, part of the Central Drugs Standard Control Organization in the Ministry of Health and Family Welfare.
The Schedule H1 drug includes 3rd and 4th generation antibiotics, anti-tuberculosis drugs and certain habit-forming drugs like psychotropic drugs. These drugs are required to be sold in the country with the following conditions:
- The drug supplied under the Schedule H1 specification should be recorded in a separate register at the time of supply, mentioning the name and address of the prescriber, name of the patient, and the name of the drug along with the quantity supplied. This register has to be maintained confidentially up to three years and should be open for inspection.
- The schedule H1 drugs should be labelled with the symbol Rx in red, clearly displayed on the left top corner of the drug label. The label should also bear the following words in a box with a red border.
“Schedule H1 Drug-Warning: It is dangerous to take this preparation except in accordance with the medical advice. Not to be sold by retail without the prescription of a Registered Medical Practitioner.”
The letter said that anti-microbial resistance (AMR) is one of the top global public health threats facing humanity. It also said that misuse and overuse of anti-microbials is one of the main drivers in development of drug resistant pathogens. With few new antibiotics in the research and development pipeline, prudent antibiotic use is the only option to delay the development of resistance.
This comes on the heels of a recent survey by the National Centre for Disease Control which showed that 71.9% of the patients coming to tertiary care hospitals were prescribed antibiotics. And, more than half of these prescriptions were not to treat an infection, but administered as prophylaxis (preventive) before procedures and surgeries. It was further stated that AMR is one of the top global public health and development threats. It is estimated that bacterial AMR was directly responsible for 1.27 million global deaths in 2019 and 4,95 million deaths were associated with drug resistant infections.
An antibiotic is a type of anti-microbial substance active against bacteria. It is the most important type of anti-bacterial agent for fighting bacterial infections, and antibiotic medications are widely used in the treatment and prevention of such infections—they may either kill or inhibit the growth of bacteria. A limited number of antibiotics also possess antiprotozoal activity.
Antibiotics are not effective against viruses, such as the ones which cause common cold or influenza, drugs which inhibit growth of viruses are termed antiviral drugs or antivirals rather than antibiotics. They are also not effective against fungi; drugs which inhibit growth of fungi are called anti-fungal drugs.
Sometimes, the term antibiotic—literally “opposing life”, from the Greek root anti, “against” and bios, “life”—is broadly used to refer to any substance used against microbes, but in the usual medical usage, antibiotics (such as penicillin) are those produced naturally (by one micro-organism fighting another), whereas non-antibiotic anti-bacterials (such as sulfonamides and antiseptics) are fully synthetic. However, both classes have the same goal of killing or preventing the growth of micro-organisms, and both are included in antimicrobial chemotherapy.
“Antibacterials” include bactericides, bacteriostatics, anti-bacterial soaps, and chemical disinfectants, whereas antibiotics are an important class of anti-bacterials used more specifically in medicine, sometimes in livestock feed.
Antibiotics have been used since ancient times. Many civilizations used topical application of mouldy bread, with many references to its beneficial effects arising from ancient Egypt, Nubia, China, Serbia, Greece, and Rome. The first person to directly document the use of moulds to treat infections was John Parkinson (1567-1650). However, the effectiveness and easy access to antibiotics have also led to their overuse and some bacteria have evolved resistance to them. The World Health Organization has classified anti-microbial resistance as a widespread “serious threat”. Global deaths attributable to anti-microbial resistance numbered 1.27 million in 2019.
Antibiotics are used to treat or prevent bacterial infections, and sometimes protozoan infections. (Metronidazole is effective against a number of parasitic diseases). When an infection is suspected of being responsible for an illness, but the responsible pathogen has not been identified, an empiric therapy is adopted. This involves the administration of a broad-spectrum antibiotic based on the signs and symptoms presented and is initiated pending laboratory results that can take several days.
Antibiotics may be given as a preventive measure and this is usually limited to at-risk populations, such as those with a weakened immune system (particularly in HIV cases to prevent pneumonia), those taking immunosuppressive drugs, cancer patients, and those having surgery. Their use in surgical procedures is to help prevent infection of incisions. They have an important role in dental antibiotic prophylaxis where their use may prevent bacteremia and consequent infective endocarditis. Antibiotics are also used to prevent infection in cases of neutropenia, particularly cancer-related. The use of antibiotics for secondary prevention of coronary heart disease is not supported by current scientific evidence, and may actually increase cardiovascular mortality, all-cause mortality and the occurrence of stroke.
AMR puts many of the gains of modern medicine at risk. It makes infections harder to treat and makes other medical procedures and treatments—such as surgery, caesarean sections and cancer chemotherapy—much riskier. The misuse and overuse of antimicrobials in humans, animals and plants are the main drivers in the development of drug-resistant pathogens. AMR affects countries in all regions and at all income levels. Its drivers and consequences are exacerbated by poverty and inequality, and low-and middle-income countries are most affected. In addition, drug-resistant infections impact the health of animals and plants, reduce productivity in farms, and threaten food security.
—By Adarsh Kumar and India Legal Bureau