THIRU KUMARAPILLAI VAIDYAR Vs. DISTRICT COLLECTOR

JUDGEMENT

(1.) In Kanyakumari District, preparation of Asavas and Arishtas, which are supposed to be used by public for specific ailments and tonic, is in vogue for centuries. These are prepared from medicinal plants in accordance with the recognised pharmacopoeia Sahasrayogam. The alcoholic content, which is self-generated is less than 10% in volume and such preparations are unrestricted preparations within the meaning of Rule 60(1) read with Schedule of the Medicinal and Toilet Preparations (Excise Duties), Rules 1956. It is the claim of the petitioners that though licence had been issued by the Drug Controller to manufacture Asavas and Arishtas as indicated in the licence, the police officials unduly interfere in the manufacture, transport and sale of ayurvedic preparations. It is stated that the respondents are illegally seizing the stock, destroying the articles found in the manufacturing unit, seizing the transport vehicles by illegally invoking the Tamil Nadu Prohibition Act and the Rules made thereunder. It is contended that unnecessary interference by the police in the right of the petitioners to manufacture, transport or sell such ayurvedic medicines is violative of Article 19(1)(g) of the Constitution of India. It is further asserted that the District Collector, who has jurisdiction to issue L2 licence under the Medicinal and Toilet Preparations (Excise Duties), Rules 1956, had arbitrarily rejected many of the applications. Under these circumstances, the petitioners have prayed for issuance of writ of mandamus forbearing the respondents and their subordinates from interfering with the manufacture possession, transport and sale to retailers and other authorised agents made under the authority of the petitioners Drug Licence issued by the Drug Controller, Chennai arbitrarily applying the provisions of the Tamil Nadu Spirituous Preparation Control Rules, 1984 that are applicable to the restricted preparations on the unrestricted preparations of the petitioners.

(2.) Before considering the various contentions raised by the various petitioners, it would be appropriate to notice the relevant statutory provisions. The first statute to be considered is the Drugs and Cosmetics Act. As per Section 3(a) of this Act, Ayurvedic, Siddha or Unani drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, specified in the First Schedule. Chapter IV of the Act relates to manufacture, sale and distribution of drugs and cosmetics. Section 17, 17A,17B relate to misbranded drugs adulterated drugs and spurious drugs respectively. Section 18 provides that no person shall manufacture for sale or for distribution or sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic, except under, and in accordance with the conditions of, a licence issued for such purpose under the Chapter. Under Section 18B persons holding licence under Section 18(c) are required to maintain records, registers as may be prescribed. Section 33 of the Act empowers the Central Government to make Rules. Section 33(2))e) relates to the forms of licences for the manufacture for sale or for distribution of drugs. Chapter IVA contains the provisions relating to ayurvedic, siddha and unani drugs. Sections 33E, 33EE and 33EEA contain provisions relating to misbranded drugs, adulterated drugs and spurious drugs for the purpose of Chapter IVA. Section 33EEB provides that no person shall manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordasnce with such standards, if any, as may be prescribed in relation to that drug. Section 33EEC relates to prohibition of manufacture and sale of certain ayurvedic, siddha and unani drugs and being relevant, is extracted hereunder :- 33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drugs From such date as the State Government may, by notification in the Official Gazette, specify in this behalf, no person, either by himself or by any other person on his behalf, shall- (a) manufacture for sale or for distribution- (i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drug; (ii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true list of all the ingredients contained in it; and (iii) any Ayurvedic, Siddha or Unani drug in contravention of any of the provisions of this Chapter or any rule made thereunder; (b) sell, stock or exhibit or offer for sale or distribute any Ayuvedic, Siddha or Unani drug which has been manufactured in contravention of any of the provisions of this Act, or any rule made thereunder; (c) manufacture for sale or for distribution, any Ayurvedic, Siddha or Unani drug, except under, and in accordance with the conditions of a licence issued for such purpose under this Chapter by the prescribed authority; PROVIDED that nothing in this section shall apply to Vaidyas and Hakims who manufacture Ayurvedic, Siddha or Unani drug for the use of their own patients: PROVIDED FURTHER that nothing in this section shall apply to the manufacture, subject to the prescribed conditions, of small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination, test or analysis. Section 33-I contains the provisions for infliction of penalty on any person who manufactures for sale or for distribution, any ayurvedic drug which is deemed to be adulterated under Section 33EE or without a valid licence as required under Section 33EEC(c) and similarly under Section 33-I (b) a person who manufactures for sale spurious drugs as described in 33EE or 33EEA is also punishable. Section 33K relates to confiscation of the stock of the ayurvedic, siddha and unani drugs in respect of which contravention has been made. Chapter V contains Miscellaneous provisions. Section 34AA authorises imposition of penalty for vexatious search or seizure. Section 37 provides no suit, prosecution or other legal proceedings shall lie against any person for anything which is in good faith done or intended to be done under this Act. Schedule I of the said Act contains the name of various approved books as per Section 3(a) of the Act. Entry No.28 refers to Sahasrayoga.

(3.) The Medicinal and Toilet Preparations (Excise Duties) Act, 1955 provides for levy and collection of duties of excise on medicinal and toilet preparations containing alcohol, opium, Indian hemp or other narcotic drug. Section 2 contains the definition clauses. Under Section 2(a) alcohol means ethyl alcohol of any strength and purity having chemical composition C2H5OH. In exercise of power conferred under section 19 of the Act, the Medicinal and Toilet Preparations (Excise Duties) Rules, 1956 have been framed. As per Rule 2(xx) unrestricted preparation means any medicinal preparation containing alcohol but other than a restricted preparation or a spurious preparation. Clause (xix) defines restricted preparation to mean every medicinal preparation specified in the schedule and includes every preparation declared by the Central Government as restricted preparation under these rules. Chapter IV of the Rules relate to manufacture. Rule 52 provides manufacture, storage and sale shall be carried on in the licensed premises only. Rule 64 lays down the type of preparation, such as Asavas, Aristas, in which alcoholic contents is self-generated. Rule 65 provides that a standard pharmacopoeia has been evolved by the Central Government. Pharmacopoeias in various states are recognised as standard Ayurvedic pharmacopoeias. Rule 66 envisages that no duty shall be levied on Ayurvedic preparations containing self-generated alcohol in which the alcoholic content does not exceed 2 per cent. proof spirit and where the percentage of proof spirit is in excess of 2 per cent. duty would be leviable. The proviso being relevant, is extracted hereunder : Provided that Ayurvedic practitioner registered under any law for the time being in force in any State where there is no such registration of Ayurvedic practitioners, such practitioners, as are proved to satisfaction of the Excise Commissioner to be of good standing, shall be allowed to manufacture and dispense Ayurvedic preparations, excepting those prepared by distillation or by addition of alcohol as such during the process of manufacture or to the finished product, free of duty subject to the following conditions: (a) Practitioners shall take out licence on payment of fee of Re.1 in the manner hereinafter stated; (b) such preparations shall be used only for the patients of the practitioners and shall not be for sale to the general public; (c) the practitioner shall allow drawing of samples by Excise Officer to ensure that the preparations contain only self-generated alcohol; and (d) daily account shall be maintained of all the preparations manufactured and dispensed giving particulars of names and addresses of the patients of the practitioners. Chapter VI relates to licensing. Rule 82 prescribes the procedure for obtaining licence and Rule 83 prescribes the form of application for a licence. Rule 94 prescribes that no licence for the manufacture of medicinal and toilet preparations or renewal of such licence shall be granted to an applicant unless he holds the requisite licence under the Drugs and Cosmetics Act, 1940 for the manufacture of the said medicinal preparations. Rule 95 prescribes the requirements to be considered by the licensing authority. Chapter IX relates to entry, search seizure and investigation.