
The Supreme Court on Friday declined to hear a petition challenging the continued distribution of the homoeopathic drug Arsenicum Album in Kerala, which was promoted as an immunity booster during the COVID-19 pandemic without proper clinical trials. A bench led by Chief Justice of India Surya Kant observed that the issue may not be appropriate for the current platform and suggested filing a separate petition.

Senior Advocate Anand Grover, representing the petitioner, argued that homoeopathic medicines are subject to clinical trials under the Drugs and Cosmetics Act and that no such trials were conducted for Arsenicum Album. He noted that while emergency considerations may have applied during COVID, the drug is still being administered to children in Kerala, which warrants scrutiny. The court, however, said an independent inquiry would be needed and declined to intervene.
The core question here is whether AYUSH drugs, which have a separate regulatory pathway under the Drugs and Cosmetics Act, require the same level of clinical trials as allopathic medicines before mass administration. The Drugs and Cosmetics Rules, 1945, through Schedule M-I, exempt homoeopathic drugs from certain clinical trial requirements if they are included in the Homoeopathic Pharmacopoeia of India. Arsenicum Album is listed in that pharmacopoeia, which may explain the government's legal basis for its use. However, the petitioner's argument centres on the drug being administered as a prophylactic during a public health emergency, which could fall under a different regulatory standard. The next step is whether a fresh petition is filed specifically challenging state-level protocols, which would require the court to examine if AYUSH guidelines were properly followed.
Source: barandbench.com
This story was synthesised by AI from the source linked above. Methodology and corrections.