Government bans 156 fixed-dose combination drugs; doctors explain why

Earlier this month the Union Ministry of Health and Family Welfare announced a ban on 156 fixeddose combination drugs FDCs through a Gazette notification The notice prohibits the manufacture sale and distribution of these drugs in the countryAn FDC includes more than one active ingredient ie it contains two or more drugs in a single pill or capsule According to the notification an Expert Committee appointed by the Central Government and the Drug Technical Advisory Board DTAB found these 156 drugs to be lsquoirrationalrsquo and lsquono therapeutic justificationrsquo was found for the ingredients used in them It even stated that these may cause risk to human lifeIn the larger public interest it is necessary to prohibit the manufacture sale or distribution of these FDCs under Section 26A of Drugs and Cosmetics Act 1940rdquo the statement readThe banned drugs include antibiotics for cold fever etc antiallergy medicines painkillers and multivitamins Some banned FDCs are Mefenamic Acid Paracetamol Injection Cetirizine HCl Paracetamol Phenylephrine HCl Levocetirizine Phenylephrine HCl Paracetamol Paracetamol Chlorpheniramine Maleate Phenyl Propanolamine Camylofin Dihydrochloride 25 mg Paracetamol 300 mg Meclizine HCl Paracetamol Caffeine and Tramadol HCl Paracetamol Caffeine TaurineGiven this development we speak to Dr Aklesh Tandekar Head Consultant Critical Care Wockhardt Hospitals Mira Road and Dr Pradeep Kwatra Senior Consultant Internal Medicine Apollo Spectra Hospital Delhi to understand how FDCs work and why they have been bannedWhat are FDCs and how do they functionTandekar FDCs include a combination of medicines ie active ingredients These are taken together in one pillcapsuleinjection They are available in different combinations but fixed combinations This is generally done to avoid taking multiple medicines and to improve the adherence by the patientThese drugs work by different mechanisms They have different pathways And these pathways synchronise with each other so that they have enhanced effects For example I have pain For pain you have multiple receptors If you use different drugs together multiple receptors will receive the effect and together you will have enhanced action of this medicine and the patient will have better pain relief When these medicines work synergistically the amount of concentration of the drug required is reduced So the dosages of these medicines are also reducedFDCs do have some benefits The efficacy is improved Patients will have targeted and more definitive forms of benefits from these medicines The most important advantage is patient compliance If there is one medicine to consume the patient usually doesnrsquot skip it And then the patients response to the treatment is enhancedKwatra Fixed combination drugs FDCs are a type of medication that combines two or more active ingredients into a single pill or dosage They are specially designed to treat several symptoms or conditions like HIV AIDS diabetes tuberculosis and high blood pressure The primary goal of combination drugs is to treat a particular disease by taking one single tablet or capsule to make the patient more compliant and to reduce the pill burden and cost of medicationWhy has the government banned these 156 FDCsTandekar Several other reasons led to the banning of these medicines Some of these medicines may have adverse reactions and increased risk of side effects This is not the case with all FDCs but some have been banned These medicines are found to have safety or efficacy concerns These medicines may not be as effective as taking the drugs individually and there may be a chance of misuse by the patient Sometimes the patient can become dependent on the medicine That is very harmfulWe cannot always monitor the benefits or adverse effects of these medicines so pharmaceutical vigilance is compromised and there may be a riskbenefit imbalance The benefits may be less compared to the drawbacksSometimes there is no flexibility in terms of adjusting the dosage and some agents may even be in an excessive level In order to avoid these drawbacks the government has scrutinised a few medicines Also some of these medicines do not meet regulatory standards or guidelines so they have been banned from the marketKwatra The government has significantly banned the usage of FDCs because some combinations are not helpful for the patient We make the fixeddose combination to have a synergistic action But sometimes when we want to increase the dose in FDC it can lead to toxicity and dosage adjustment becomes difficult When these drugs interact with other medications it can significantly exacerbate onersquos symptomsAlso Read Is your sleep being sabotaged Herersquos why a digital detox is crucialWhat are the risks associated with FDCsTandekar Some combinations are particularly concerning There are medicines codeine which has been abused in combination and has a safety concern Some combinations have some lifethreatening complications related to the heart in the form of angina or sudden cardiac death Some agents may have effects on the kidneys or even cause liver failure Some patients may have hypersensitivity reactions Some of these medicines can have overdose risks also Sometimes these combinations mask symptoms If a patient is already on a beta blocker combination drug and if they get fever or tachycardia the symptoms may not be seen So the treatment or the diagnosis may be delayed in some of these patients Some of these combinations have side effects in the form of drowsiness dizziness and GI symptomsKwatra The risks associated with FDCs can vary from person to person depending on the amount of dosage consumed Dosage adjustment becomes difficult and some combinations are not fruitful The fixed combination of drugs with paracetamol or other painkillers can lead to unintentional overdose Paracetamol is widely used in various drugs capsules and pills So taking multiple FDCs can be concerning and lead to liver and kidney damage It can further lead to side effects like dizziness drowsiness gastrointestinal problems and body painAre there any alternatives to these medicinesKwatra Consult a doctor to ask your concerns related to FDCs for treating a particular condition Instead of recommending FDCs your doctor may prescribe single ingredient medications separately This significantly allows them to effectively control the dosage of each drugmedication Are medical practitioners generally aware of the effects of these drugsTandekar There has been significant awareness about these combination drugs among medical practitioners The clinical experience also matters Also this is the world of specialisation and super specialisation The primary care physicians specialists pharmacists have all developed their expertise and each one focuses on that particular specialty only Earlier general practitioners used to give medicines for different diseases also But we now have specialists for GI disease cardiovascular kidney issues etc Staying updated is the most crucial thingKwatra Qualified practitioners do know about the effects of these drugs FDCs are not preferred world over In India FDCs are used to reduce the drug cost and make the patient more compliantDisclaimer This content is for informational purposes only and should not be considered professional medical advice