By Dr. Arun Mitra
The Drug Technical Advisory Board’s (DTAB) sub-committee’s report and recommendations to ban 343 of the Fixed dose Drug Combinations (FDCs) have been welcomed by the medical professionals in general. Several organizations have been demanding ban on these combinations on the basis of evidence produced by several studies.
Treatment modalities of modern medicine are based on evidence arrived at after long laboratory and clinical trials. After production, the drug is put to trial on animals, generally the guinea pigs. It is only after there is sufficient evidence of their safety that they are put to human trials on volunteers with their consent under a lot of checks. There are set rules for commercial production of a medicine, including packing, storage and disposal. On every strip of medicine the basic information of its contents has to be provided. Literature about various benefits, side effects and contraindications is supposed to be enclosed in the medicine box.
Each drug has its own therapeutic effects and also side effects and there are specific contraindications for each medicine. This too is mentioned in the literature provided along with the medicine. Therefore, the drug has to be prescribed rationally to meet maximum benefit and minimum side effects.
Scientifically it is more appropriate that drug is formulated as a single compound. Combination products are acceptable only when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance. It is important that when the drugs are combined they should not have additional toxicity compared to if they are given separately. Dr C. S. Gautam and Dr Lekha Saha in an article published online on 21 Feb 2008 in British Journal of Clinical Pharmacology pointed out that in FDCs doses alterations in one drug is not possible without alteration of the other drug. Since many drugs may have different mode of action, there are increased chances of adverse drug effects and interactions compared with both the drugs given separately.
Betsy Louda, Associate Editor, Contract Pharma in the article published on 9 March 2018 of the publication pointed out that FDCs have increased in the last decades. This is because the cost of production in a combination is less than what is if the same drugs are manufactured separately. Because of less cost and there is improved compliance by the patients. However, the combinations are propagated by the manufacturers for more profit.
The All India Drug Action Network (AIDAN) which has been fighting against the FDCs at several forums had also filed a civil appeal in the Supreme Court saying that safety of the drug is compromised in combinations. Dr Anant Phadke of AIDAN points out that the FDCs under scrutiny account for approximately Rs. 2,500 crore in sales and represent only the tip of the iceberg. He says “In our estimation, the market of unsafe, problematic FDCs in India is at least one fourth of the total pharma market valued at Rs.1.3 trillion. The task that remains is combating the continued prevalence of a very large number of FDCs of doubtful scientific validity, which have somehow slipped through the net and been approved wrongly by the Central Government. Review of all such FDCs in the market is required in the interest of patient safety, only then can India’s pharma regulatory system hope to garner respect across the world”.
Every medicine should be taken on the prescription of a clinician under guidance and instructions about its dosage schedule. For different diseases the duration of use of a particular medicine varies. This too has to be told to the patient for effective compliance. This is important because efficacy of drugs varies in different situations. Even during the course of treatment the patient is subjected to relevant investigations to see if the drug is causing any harm and to arrive at logical decision about which drug is to be used in a particular situation.
All this is, therefore, a complex process involving lot of expertise at every step. It is advisable that no one should use medicines without consultation of a qualified doctor. Unfortunately in our country all these processes are not foolproof. The end users, the patients, also many a times do not consult the doctor and take medicines after consultation of a quack or buy medicines on their own or at the advice of chemists to cut the cost of treatment. This is a wrong practice, which the public must realize as any irrational use of drug could do more harm than good. (IPA Service)
References
1. AIDAN’s response to the DTAB sub-committee’s recommendations on FDCs Thursday, 26 July 2018
2. Chandler S Gautam and Lekha Saha
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2432494/
3. Betsy Louda, Associate Editor, Contract Pharma
https://www.contractpharma.com/issues/2018-03-01/view_features/fdcs-on-the-rise/11760
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