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1968 (5) TMI 56

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..... ccordance with the Ayurvedic and Unani systems of medicines at Delhi, Shahdara. The Inspector of Drugs, Agra Region, filed a complaint dated July 2, 1963 in the court of Magistrate, First Class, at. Mathura alleging inter alia that on September 20, 1962 when he was carrying out the inspection of the shop of M/s Frontier Gupta Medical Stores, Mathura, he came across a preparation called Antiphlogistic Plaster.manufactured by the aforesaid Corporation. On examining the label it was discovered that although the name of three drugs i.e. Glycerine, Kaolin and Boric, Acid which are to be found in Pharmacopoeias prescribed under the Act were mentioned as constituent,, of the plaster, the label did not bear manufacturing Licence Number and other particulars with which a drug was required to be labelled in accordance with Rule-96 of the Drug Rules 1945. According to the Inspector this drug fell within the mischief of s. 17 (e) of the Act and was to be deemed to be misbranded as it had not been labelled in the prescribed manner. Moreover the label of the plaster in question showed that it was a Unani preparation which was apparently a false and misleading claim. A sample was sent to the Gove .....

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..... erine, heavy Kaolin, light Kaolin and Boric Acid containing the formulae according to which these drugs were prepared were given. It was also alleged that Bindra's Antiphlogistic Plaster had been prepared in accordance with the Allopathic system of medicine since its composition resulted in a preparation known as Kaolin Poultice given at page 359 of the British Pharmaceutical Codex 1958. Glycerine, Boric Acid, Kaolin and oil of winter green Methyl Salicylate were the main components of Bindra's Antiphlogistic Plaster and those were medicines which were not exclusively used in accordance with either the Ayurvedic or the Unani system of medicine. In the further affidavit filed by the appellants it was maintained that Glycerine and Kaolin and Boric Acid were being used in the Unani system in the same way as many other things such as Honey, Rosewater, Boric or Sohaga, Sulphur i.e. Gandhak, Arsenic i.e., Sankhia, Alum i.e. Phtkari which were mentioned in the British Pharmaceutical Codes but it did not follow that they could not be used in a preparation made according to the Ayurvedic system. It was pointed out that the medicine known as Kaolin Poultice was entirely different fro .....

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..... ystem as also in the Ayurvedic or Unani systems. By way of illustration, in the Unani system fat was being used in preparation of certain medicines and instead of fat being used now Glycerine is being used. This, according to Mr. Bishan Narain, will not take the entire preparation of the Antiphlogistic Plaster as such outside the scope of the exception in the definition of drug in the Act. An attempt has, also been made to show, by reference to certain provisions of the Act, that the Government Analyst to whom the sample of the plaster was sent, was not qualified and indeed could not be qualified to express any opinion about medicines used or prepared for use in accordance with the Ayurvedic and Unani systems. The position taken up on behalf of the State is that in fact and substance all the drugs and medicines mentioned in the British Pharmaceutical Codex have been employed in the preparation of Bindra's Antiphlogistic Plaster. It is strenuously contended that by a simple device of calling it a Unani or Ayurvedic preparation in which admittedly Glycerine, Kaolin, Boric Acid etc. have been used, which find place in British Pharmaceutical Codex and are clearly drugs, the appe .....

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..... hat manufactured by a manufacturer licensed under this Chapter. Penalties were provided for the infringement of the provisions contained in the Chapter. There can be no difficulty now after the amendments made by Act XIII of 1964 in the matter of medicines and substances exclusively used or prepared for use in accordance with the Ayurvedic or Unani system of medicine provided they are processed and manufactured according to the formulae, described in the authoritative books as specified in the First Schedule. The difficulty, however, remains with regard to the true import of the exception in the definition of drug in the Act. In Chimmanlal Jagjivandas Sheth v. State of Maharashtra([1963] Sup. 1 S.C.R. 344.) the appellant had been prosecuted for an, offence under s. 18 of the Act inter alia for manufacturing drugs which were of sub-standard quality. Certain samples of absorbent cotton wool, roller bandages and guaze which he had manufactured were seized and he had not only stored them but he was also passing them off as though they were manufactured by a firm of repute at Secunderabad. The Government Analyst had reported that only the lint was of standard quality and the other .....

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..... e Ayurvedic or Unani system of medicine. The exception made in the case of latter class of medicines or substances was essentially meant to cover only such medicines or substances which were used in the Ayurvedic or Unani system or were prepared for use in accordance with those systems. In other words all medicines or substances had, under S. 16 of the Act, to comply with the standard set out in the Schedule, as it stood before the amendment made by Act XIII of 1964. In the Schedule classes of drugs and the standard which was to be complied with were set out with reference mostly to the standards maintained at the National Institute for Medical Research, London and the standards of identity, purity and strength specified in the (current edition for the time being of the British Pharmacopoeia) or the British Pharmaceutical Codex or any other prescribed Pharmacopoeia, or adopted by the Permanent Commission on Biological Standardisation of the (World Health Organisation). Only one category consisting of medicines and substances used or prepared for use exclusively in accordance with the Ayurvedic or Unani system of medicine was taken out of the definition of drug before the amendments .....

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