Misuse and overuse of antibiotics in India
24th Jan, 2019
The Union health ministry has banned 80 more Fixed-Dose Combination (FDC) drugs under the Drugs and Cosmetics Act, 1940 which include antibiotics painkillers, medicines used for treating fungal and bacterial infections, hypertension drugs like Telipril H and Loram H and anti-anxiety drug Resta (combination of Paracetamol+ Alprazolam). Total number of banned FDCs now stands at 405.
- The Union health ministry has banned 80 more Fixed-Dose Combination (FDC) drugs under the Drugs and Cosmetics Act, 1940 which include antibiotics painkillers, medicines used for treating fungal and bacterial infections, hypertension drugs like Telipril H and Loram H and anti-anxiety drug Resta (combination of Paracetamol+ Alprazolam). Total number of banned FDCs now stands at 405.
- These drugs were banned on the recommendation of the Drugs Technical Advisory Board (which was accepted by Supreme Court), which examined the rationality and safety of these FDCs and suggested prohibition of some of them.
What is a FDC drug?
- A FDC contains two or more drugs combined in a fixed ratio of doses, available as a single dose.
- Logic behind FDC is to improve adherence, simplify therapy and to maximize benefit for the patient courtesy the added effects of the multiple medicinal products (FDC) given together.
- FDCs are also of use in chronic conditions especially when multiple disorders often co-exist.
What makes FDC so popular?
- Instead of buying two, or more, separate medicines, a patient can buy just one FDC medicine to treat multiple illness symptoms, which typically reduces out of pocket expenditure (OOPE)
- Pharma companies prefer FDC because it is cheaper and quicker to combine existing active ingredients to make new products than to discover new medicines and manufacture them separately.
However, combined medicines can pose adverse effects on health system. Some of the drugs pose dangerous side-effects and unnecessary use of combination drugs makes the human body resistant to treatment.
Antibiotic resistance is one of the world's most pressing health problems:
- Antibiotics are medicines used to prevent and treat bacterial infections. Antibiotic resistance occurs when bacteria change in response to the use of these medicines.
- Bacteria, not humans or animals, become antibiotic-resistant. These bacteria may infect humans and animals, and the infections they cause are harder to treat than those caused by non-resistant bacteria.
- Any bacterium that survives an antibiotic treatment can multiply and pass on its resistant properties. Also, some bacteria can transfer their medication-resistant properties to other bacteria — as if passing along a cheat sheet to help each other survive.
- Antibiotic resistance leads to higher medical costs, prolonged hospital stays, and increased mortality.
Why antibiotics are meant to be sold only under a doctor’s prescription:
- Using antibiotics unnecessarily can expose one to unnecessary side effects.
- Each time instances of overuse/misuse of antibiotics occur, ground for creation of superbugs—bacteria that are able to survive the antibiotic—also emerge.
- Over time, the entire population of bacteria is made up only of these superbugs and the existing line of antibiotics would no longer work.
The overuse (taking antibiotics even when they're not the appropriate treatment) and misuse of antibiotics are key factors contributing to antibiotic resistance.
Action plan/ response taken against AMR
- A political declaration endorsed by Heads of State at the United Nations General Assembly in New York under the aegis of WHO in September 2016 signaled the world’s commitment to taking a broad, coordinated approach to address the root causes of antimicrobial resistance across multiple sectors, especially human health, animal health and agriculture.
By Government of India:
- The government gathered data trend in 2015 from tertiary care Centres. This data showcased high resistance to commonly used antibiotics for treatment of bacterial infections.
- Through various national, sub-national studies conducted in various institutions in India, it was observed that over/ mis-use of antimicrobial drugs are responsible for rising antimicrobial resistance in human, animal and food sectors. Other factors are inadequate sanitation and infection control practices in health care settings and also in the community.
- Government of India has launched the ‘National Programme on Containment of Antimicrobial Resistance (AMR)’ under the 12th Five Year Plan under which a surveillance lab network of ten labs has been established to monitor trends of AMR in the country.
- The Schedule H1 notification of the Government of India as an amendment to the Drugs and Cosmetics Rules of 1945, came into force from Mar 1, 2014 to control the misuse of 24 antibiotics (falling under third and fourth generation) through over-the-counter (OTC) dispensing of antibiotics in India.
- The packaging of these drugs will have mandatory Schedule H1 warning printed on the label in a box with red border and the Rx symbol in red. They can be sold by pharmaceutical chemists only on production of a valid prescription. Government drug inspectors can conduct surprise checks on these registers.
Critically evaluate linkages between FDC and rise of antimicrobial resistance in India. Suggest suitable strategies to mitigate the fallouts.