Issue

Context:

• 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.

About

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.

Background

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.

Analysis

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.

• Antibiotics treat bacterial infections but not viral infections. For example, an antibiotic is an appropriate treatment for strep throat, which is caused by the bacterium Streptococcus pyogenes. But it's not the right treatment for most sore throats, which are caused by viruses.
• Common viral infections that don't benefit from antibiotic treatment include Cold, Flu (influenza), Bronchitis, most coughs, some ear infections, some sinus infections, stomach flu.
• When infections can no longer be treated by first-line antibiotics, more expensive medicines must be used. A longer duration of illness and treatment, often in hospitals, increases health care costs as well as the economic burden on families and societies.
• There is a need to change the way antibiotics are prescribed and used. Even if new medicines are developed, without behavior change, antibiotic resistance will remain a major threat. Behavior changes must also include actions to reduce the spread of infections through vaccination, hand washing, and good food hygiene.
  
  

  Findings about Antimicrobial Resistance (AMR in India): Rising incomes, over-the-counter sale, a poorly regulated private hospital sector, high rates of hospital infection, inexpensive antibiotics and frequent infectious disease outbreaks are driving consumption in India. Use of third-generation antibiotics such as Cepahlosporins and Linezolids used to treat multidrug-resistant bacteria has increased dramatically in India since 2000 Cepahlosporins belong to a class of antibiotics called fluoroquinolones that can be administered orally. When resistance to these drugs increases, patients have to stay in hospital longer for antibiotics to be given intravenously or intramuscularly, which pushes up cost and puts them at risk of other hospital infections.Organ transplantations, chemotherapy and surgeries such as caesarean sections become much more dangerous without effective antibiotics for the prevention and treatment of infections.

  Appropriate use of antibiotics

  Generic

  • Practice good hygiene, to avoid bacterial infections that need antibiotic treatment.
  • Take recommended vaccinations. Some recommended vaccines protect against bacterial infections, such as diphtheria and whooping cough (pertussis)
  • Reducing risk of getting a foodborne bacterial infection. Avoiding drinking raw milk, washing hands, and cooking foods to a safe internal temperature.
  • Using antibiotics only as prescribed by the doctor. Taking the prescribed daily dosage, and completing the entire course of treatment.
  • Not to take leftover antibiotics for a later illness. They may not be the correct antibiotic and would not be a full course of treatment
  • Non Substitution: Not to use antibiotics prescribed for another person.
  • Preparing food hygienically, following the WHO Five Keys to Safer Food (keep clean, separate raw and cooked, cook thoroughly, keep food at safe temperatures, use safe water and raw materials) and choose foods that have been produced without the use of antibiotics for growth promotion or disease prevention in healthy animals

  Pointer specific to the agricultural sector:

  • Administering antibiotics to animals only under veterinary supervision.
  • Not using antibiotics for growth promotion or to prevent diseases in healthy animals.
  • Vaccinate animals to reduce the need for antibiotics and use alternatives to antibiotics when available.
  • Improve biosecurity on farms and prevent infections through improved hygiene and animal welfare.

Action plan/ response taken against AMR

By WHO:

• 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.

Learning Aid

Practice Question:

Critically evaluate linkages between FDC and rise of antimicrobial resistance in India. Suggest suitable strategies to mitigate the fallouts.