BANNING OF DRUGS
WHY IN NEWS ?
- Recently the government has banned the manufacture, sale and distribution of 14 fixed dose combination (FDC) drugs, citing “no therapeutic justification”.
WHAT ARE FIXED DOSE COMBINATION (FDC) DRUGS ?
- An FDC is a cocktail of active ingredients used in a fixed ratio in a single pill or syrup.
- Such combinations can reduce the ‘pill burden’, improve adherence to therapy and bring down costs.
- Thousands of FDC drugs are available in India and have been sold for decades.
- Many FDCs are considered safe—for instance, in the treatment of tuberculosis or HIV.
- However, there are certain combinations that can be pharmacologically incompatible, have abuse potential and could lead to antibiotic resistance in the population.
- A drug that has both acidic and alkaline ingredients would be ineffective.
WHAT ARE IRRATIONAL FDCs ?
- FDCs using a combination for the first time are deemed “new” drugs and, hence, require prior approval from the Drugs Controller General of India (DCGI) before being licensed by the state licensing authorities (SLAs).
- However, many FDCs were licensed by SLAs without prior approval of DCGI, leading to an influx of drugs with little evidence on safety and efficacy.
- In 2016, after a panel found many of these FDCs “irrational”, the government banned 344 FDCs.
- However, this ban was stayed by the Delhi high court.
- The Centre then moved the Supreme Court against the stay order.
REASON BEHIND LATEST BAN :
- The ban on 14 FDCs (for instance, Nimesulide + Paracetamol dispersible tablets) licensed prior to 1988, was recommended by an expert committee constituted by the union government.
- Around 40-50 brands currently available in the market could be affected by the ban.
- These drugs are used for cough, fever, pain and common infections.
- Paediatricians have welcomed the move, calling many of these combinations harmful.
- But many want to ban Nimesulide for single dose use as well, citing risks to the liver.
- The ban was imposed based on the recommendations of Kokate committee.
- It was imposed over fears that these drugs cause anti-microbial resistance and might even cause organ-failure because of high toxicity.
- It was also aimed at curbing the misuse of medicines.
KEY BENEFITS OF FDCs:
- Greater efficacy compared with higher dose monotherapy.
- Reduced risk of adverse reactions relative to higher dose monotherapy.
- Lower overall costs.
- Improved medication concordance.
DRAWBACKS OF FDCs DRUGS :
- There are increased chances of adverse drug effects and drug interactions compared with both drugs given individually.
- The most pressing concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions.
- Irrational FDCs also impose unnecessary financial burden on consumers.
- Medical practitioners who patronize such combinations could be the centre of controversy when subjected to litigation in consumer forums.
- Other demerits includes inflexible fixed dose ratio, incompatible pharmacokinetics, increased toxicity, and physician and pharmacist ignorance of content.
RECENT CASES OF COUGH SYRUPS :
- One of the most pervasive use of FDCs is in cough syrups.
- More recently, last year the Centre moved to ban 19 codeine-based FDCs.
- Codeine is basically an antitussive (medication that suppresses cough), it is not an expectorant and is generally used for the treatment of dry cough.
- Such kinds of coughs are basically attributed to allergic manifestations or to patients who are working in dusty environments.
- Codeine-based formulations constitute roughly a Rs 1000 crore market.
- Many experts argue that the ingredients used in them often work against one another, nullifying the effect.
- The evidence that cough syrups reduce the natural course of cough is weak.
- The USFDA has warned against their use for children.
- However, expectorants which ease the release of mucus is okay to use.
- Even among adults, cough suppressants should not be used without prescriptions, for it can pose risks to those with lung problems.
BANNED FDCs :
- Some of the banned FDCs –
Nimesulide+ Paracetamol dispersible tablets
Chlorpheniramine + Codeine Phosphate + Menthol Syrup
WAY FORWARD :
- However it is not advisable to ban each and every FDC drug considering the huge market size. It will cause great shock to pharmaceutical industry.
- However, the rationality of FDCs in the future should be determined based on the ingredients in the combination should work by different mechanisms and pharmacokinetics.
- All manufacturing facilities should be licensed by a single national regulator so that it can be held accountable.
SYLLABUS: MAINS, GS-2, HEALTH