Rebuttal to: A series of homeopathic remedies-related severe DILI from South India.

This has reference to the publication questioning the safety of homeopathic medicines and their relation to DILI (Hom-DILI).1 The safety of homeopathic medicines has been given due consideration by the World Health Organization.2 The Government of India has laid down standards for the manufacturing of drugs.3 A recent meta-analysis found no differences in the frequency of adverse reactions between homeopathic and placebo treatments.4 Even NHS, a source quoted by the authors in the paper, reports Homeopathy to be safe.5 As such, in the nine cases of drug-induced hepatotoxicity, it needs to be identified if: The drugs were indeed homeopathic drugs. The drugs were prepared by licensed GMP-certified manufacturers. The drugs were being used as per the prescription of a qualified homeopathic practitioner. The practitioner was prescribing the drugs as per the principles of classic homeopathy. If the ultradiluted form of each drug resulted in similar DILI as its crude or mother tincture form. In the absence of a detailed assessment, it is hasty on the part of the authors to blame the entire system and ultradiluted homeopathic drugs to be responsible for hepatoxicity. The Government of India has launched a program on pharmacovigilance of complementary/alternative drugs, under which ADRs observed by a practitioner are to be reported to the nearest pharmacovigilance center using a reporting form for ASU&H Drugs (National Pharmacovigilance Program for ASU&H Drugs; https://www.ayushsuraksha.com/suspected-adverse-reactions). The authors have not detailed whether they have complied to these guidelines of the Indian government, as no data are presented for causality assessment done subsequently by the concerned regulatory authorities. The authors refer to the term “classic homeopathy” in their conclusion, without fully knowing that such type of homeopathy neither advocates the use of formulations nor mother tinctures—both the type of drugs that have mostly come out to be the reasons behind Hom-DILI in the paper. The therapeutic system cannot be blamed for some malpractice by a manufacturer, a practitioner, or noncompliance of a patient to the prescribed schedule, all of which are extrinsic factors, and can occur in any medical system. Also, a comparative assessment of final outcomes based on the drug history of all 243 patients would have made for a more factual and scientific evaluation of drugs responsible for DILI while also probing the factors behind it in an unbiased manner.