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(d) It is not in dispute that the drug in question, i.e., 'OMNIGEL', is not a pharmacopoeial drug. It is a combination of a few other drugs, viz., Linseed Oil, Diclofenac Diethylamine, Methyl Salicylate & Menthol Gel.

(e) It is the contention of the learned Government Advocate that though the drug in question is a patent drug, it consists of certain Pharmacopoeial drugs and therefore, Rule 46(3) of Rules would be applicable and tests have been conducted in terms of the said rule. The question as to whether the patent drug consists of pharmacopoeial drugs, is a disputed question of fact and has to be adjudicated only in the trial. https://www.mhc.tn.gov.in/judis ( Uploaded on: 14/05/2025 04:16:46 pm ) Crl.O.P.Nos.19643 & 19832 of 2022 Further, it is also seen that Sub rule 4 of Rule 46 also provides for the procedure for testing patent or proprietary medicines and that the procedure prescribed in Standard Books or Journals can be followed. The lab reports suggest that a particular method has been adopted to test the samples. For instance, one of the ingredients, viz., Diclofenac Diethylamine, was tested by 'British Pharmacopoeial (BP)' method. The other ingredients, viz., Methyl Salicylate and Menthol Gel were tested by 'Gas Chromatography' method.