(1) No person shall manufacture any spirituous preparation except under and in accordance with the terms and conditions of a licence issued under the Medicinal and Toilet Preparations (Excise Duties) Rules, 1956.
(2) All preparations manufactured without licence under the Medicinal and Toilet Preparations (Excise Duties) Rules, 1956 and those that are found to be spurious shall be liable to confiscation. If any preparation manufactured by a manufacturer is found to be spurious, further manufacture by him shall be stopped and the entire stock of the preparation manufactured by him shall be seized and detained till the manufacturer gets each of the preparations so seized and detained classified by the Commissioner of Prohibition and Excise as laid down in Rule 5.
(3) No Manufacturing licensee under the Medicinal and Toilet Preparation (Excise Duties) Rules, 1956 shall manufacture any restricted preparation in quantities greater than hose permitted by the Commissioner of Prohibition and Excise. In fixing the quantity of restricted preparations that may be manufactured, the Commissioner of Prohibition and Excise shall take into account-
(a) the advice of Expert Committee regarding the total requirements of medicinal preparations containing liquor or intoxicating drug or in which alcohol is self-generated for the whole State during one year;
(b) the requirements for export out of the State; and
(c) the likely imports in to the State.
(4)Every manufacturer of restricted preparations shall maintain proper accounts in Form S.P.I. for each of the ingredients purchased or obtained which go into the manufacture of the preparation or preparations.
The bills of purchase of such ingredients shall also be preserved for a period of one year and produced for check or inspection whenever demanded by an officer not below the rank of a Deputy Tahsildar, Taluk Excise Officer, Drug Inspector or an Inspector of Police.
(5) (a) Every receptacle containing medicinal or toilet preparations manufactured, imported or stocked or kept for sale or sold must be conspicuously labelled with a printed lable showing clearly;
(i) the manufacturer‟s name and address;
(ii) the name of the preparation;
(iii) (1) the name of the pharmacopoeia according to which the preparation is manufactured; or
(2) the number and date of the order of the approval of the State Government in respect of patent and proprietary preparations;
or
(3) the number and date of the notification issued by the Commissioner of Prohibition and Excise in respect of a preparation approved as bona fide medicinal preparation by the Expert Committee; and
(4) the contents in milli -litres;
(b) The label shall also show the dosage to be administered, the alcoholic contents in proof strength, average percentage of alcohol it contains and the price;
Provided that this condition shall not be insisted on, unless the Commissioner of Prohibition and Excise in any particular case so directs, in the case of preparations manufactured by holders of L3 licence issued under the Medicinal and Toilet Preparations (Excise Duties) Rules, 1956 for dispensing to their patients at the premises of the manufactory.
7. Import –
(1) No restricted preparation shall be imported into the state except under cover of an import permit in Form S.P.II granted by the Commissioner of prohibition and Excise. Any person desiring to import any restricted preparation shall apply in Form SP III which shall be duly stamped to the Commissioner of Prohibition and Excise. The Commissioner of Prohibition and Excise after such enquiries as he deems necessary, may grant the applicant an import permit in Form S.P.II on payment of Rs. 5/- (Rupees Five only) for each item to be imported or may refuse to grant a permit for sufficient reasons to be recorded. The Commissioner of Prohibition and Excise shall, in exercising his powers under this Rule, have regard to the following considerations, namely:-
(a) Whether the preparations are required –
(i) for purposes of bona fide trade and commerce;
(ii) for meeting the bona fide requirements of the State; and
(b) whether the applicant has been convicted of any offence under the Act, Dangerous Drugs Act, 1930 (Central Act II of 1930), Opium Act, 1878 (Central Act II of 1878), or Medicinal and Toilet Preparations (Excise Duties) Act, 1955 (Central Act 16 of 1955) for any cognisable offence.
(2) Import made under the provision of the Spirituous Preparations (Inter State Trade and Commerce) Control Act, 1955 (Central Act 39 of 1955) and the Rules made there under shall be deemed to be an import duly made under this rule and the import licence issued under the provisions thereof shall be taken as import permit issued for the purposes of this rule.
(3) The Joint Commissioner (Prohibition and Excise) or the Assistant Commissioner (Prohibition and Excise), Office of the Commissioner of Prohibition and Excise, Chennai-5, may also issue permits specified in subrule (1) if so directed by the Commissioner of Prohibition and Excise.
(4) The consignment of preparations imported under this rule shall not be opened and taken into stock by the importer unless it is verified by the Tahsildar or an Excise Officer authorized on his behalf.
(5) The Commissioner of Prohibition and Excise, may in his discretion grant a general import permit for a period not exceeding one year at a time in respect of restricted preparations, if he is satisfied that a large number of imports at frequent intervals have to be made form the sources outside the State on payment of an annual fee of Rs.150 (Rupees one hundred and fifty only). The application shall be in Form S.P.III and the permit shall be issued in Form S.P.IV.
(6) The loss of an import permit during the period of its currency shall forthwith be intimated by the holder of the permit to the authority who issued the import permit, explaining the circumstances in which, the loss had occurred. If the consignment has been received, the holder of the permit shall furnish the details of the products received and the suppliers from whom they are received. A fee of Rs.25 (Rupees twenty five only) shall be payable for every duplicate permit for which the applicant shall apply in Form S.P.III. The duplicate may be granted by the authority who issued the original permit after making such enquires as it deems fit The fee shall be remitted under the head of accounts “039, State Excise – (i) other receipts 04 miscellaneous.” The holder of the permit shall return the duplicate permit for cancellation, if and when the original import permit is traced out.
8. Exports –
(i) No restricted preparation shall be exported out of the State excepts under over of an export permit in Form S.P.V granted by the Collector having jurisdiction over the place from which the export is made.
Any person desiring to export any preparation out of the State shall apply in form S.P. VII which shall be duly stamped to the Collector along with the import permitor a no objection certificate from the Excise authorities of the state to which the expot is to be made. A fee of Rs.5. (Rupees five only) Shall be payable for each item to be exported.
(2) The Commissioner of Prohibition and Excise may in his discretion, grant a general export permit in Form SP VI for a period not exceeding one year at a time in respect of restricted preparations, if he is satisfied on an application made by a person in form S.P VIII and on payment of an annual fee of Rs. 150 (Rupees one hundred and fifty only) that a large member of exports at frequent intervals have to be made to places outside the State.
(3) Export made under the provision of the Spirituous Preparations (Inter State Trade and Commerce) Control Act, 1955 (Central Act 39 of 1955) and the rules made there under shall be deemed to be an export duly made under this rule and the licence issued under the provision ther of shall be taken as the export permit issued for the purposes of this rule.
9. Transport –
(1) the transport of all restricted preparation in excess or the quantity permitted to be possessed under rule 10 from one place to another within the state shall be covered by a transport permit in form S.P. IX issued by the licenisee from whom the preparation is transported. One copy of the permit shall be carried with the consignment, an another copy shall be sent to the Taluk Excise Officer of the Taluk from where the transport is made, the third copy shall be sent to the Taluk Excise Office of the Taluk to which the preparation is transported and the fourth copy shall be kept by the licensee as counterfoil.
(2) The movement of restricted preparations issued by hospitals and dispensaries of the strength of prescriptions issued by Medical practitioners shall, if it exceeds 3.75 milli - liters, be accompanied by such prescription or other proof and in case of issue by licensees upto the limit prescribed in Rule 10, by the bill of sale also.
10. Possession –
(1) No person shall, possess any restricted preparation except under and in accordance with the terms and conditions of a licence or permit issued under these Rules and in excess of the quantity entered in such licence of permit;
Provided that –
(a) the medical practitioners specified in column (1) of the Table below may possess at any one time for their professional use and for issue to their patients for bona fide treatment, mitigation or prevention of disease, preparations up to the limits specified against each in column (2) thereof, but not for sale on other physician‟s prescriptions;
(b) any person may, for his personal consumption, for bona fide treatment, mitigation or prevention of disease, possess with out a licence, but on a prescription issued by a registered medical practitioner mentioned in the Table below any preparation not exceeding the quantity specified in the prescription;
(c) any person may, for his personal consumption, for bona fide treatment, mitigation or prevention of disease, possess without a licence or prescription –
(i) any preparations manufactured under the Ayurvedic, Unani or Sidda system of medicine not exceeding three litres of each provided the total quantity of all such preparations does not exceed four and a half litres;
(ii) any Allopathic preparation in the nature of a tonic not exceeding four and a half litres;
(iii) tincture iodine or tincture benzoine or such other tinctures as may be notified by the Commissioner of prohibition and Excise;
(iv)mixture issued by hospitals or dispensaries on proper prescription in quantities no exceeding 375 millilitres; and (D) any person may possess toilet preparations not exceeding two litres for his personal use.
THE TABLE Class of Medical Practitioners Quantity of preparations allowed to be possessed at any one time.
(1) (2)
(1) Registered Medical Practitioner 5,000 milliliters to each preparation/ (in case of allopathic Preparation) 2) Registered Homeopathic medical 375 milliliters of each homeopathic practitioner. preparation.
3) Registered Medical Practitioner a) Five litres of each of any Asava in the Indigenous system of or Arishta Medicines. b) Preparations containing drug not exceeding 40 grams of drug content: and c) 150 milli-litres of any ayurvedic preparation containing added alcohol.
4) Medical Practitioner in charge of 10,000 milli-litres of each an Institution (other than preparation.
Government Local Fund, Municipality, Corporation or Charitable Institution) such as hospital or maternity home
Explanation – If the Quantity prescribed above is not sufficient for any medical practitioner mentioned in item (4) of the Table above, the Commissioner of prohibition and Excise may allow such quantity as may be considered necessary in each case.
(2) All medical practitioners mentioned in the Table in sub-rule (1) shall maintain a register in Form S.P. X in respect of restricted preparation
11. Licences for Sale –
(1) Licences for the sale of spirituous preparations shall be of the following descriptions, namely:- a) Wholesale licence –
(1) Wholesale licence in Form S.P XI shall be issued by the Collector-
(i) for sale of allopathic medicinal preparations to those holding licences in Forms 20-B and 21-B under the Drugs and Cosmetics Rules 1945;
(ii) for sale of any homoeopathic medicinal preparation or any preparation coming under the indigenous system of medicine to a registered medical practitioner or to those holding licence in Form L-1 or L-2 under the Medical and Toilet Preparations (Exercise Duties) Rules 1956, or a licence under the Drugs and Cosmetic Act,1940 (Central Act XXIII of 1940); and
(iii) for sale of other preparations to those possessing such qualifications as may be specified by the Commissioner of Prohibition and Excise.
(2) No Wholesale licence shall be issued except on payment of a fee of Rs. 100 (Rupees one hundred only) for a year or part thereof
(b) Retail sale licence –
(1) Retail sale licence in Form S.P. XIII shall be issued – i) for sale of allopathic medicinal preparations , to those holding liceces in Forms 20 and 21 under the Drugs and Cosmetic Rules 1945.
ii) for sale of any homoeopathic medicinal preparation or any preparation coming under the indigenous system of medicine, to a registered medical practitioner to those recognized by the State Government or the Government of India as competent authorities for dispensing these preparations to the public or to the holder of a licence under the Drugs and Cosmoties Act.1940 (Central Act XXIII of 1940); and iii) for sale of other preparations to those possessing such qualifications as may be specified by the Commissioner of prohibition and Excise.
2) No retail sale licence shall be issued except on payment of a fee of Rs. 25 (Rupees twenty five only) for a year or part there of in case of a licence for sale of allopathic medical preparations
Explanation – Sale by one wholesale licence to another for purpose of resale , sale to medical officers for supply to their patients and sale to hospitals, dispensaries, maternity homes and other institutions shall be deemed to be wholesale sales and all other sales to the retail sales.
2) No registered dealer shall possess for sale any restricted preparation in the state in excess of the quantity specified in the licence in Form S.P.XIV
Explanation (1) The Collector shall specify in the licence in Form S.P XIV, the quantity of each of he restricted preparation that may be possessed at any one time by a registered dealer.
Explanation (2) Registered dealers are those who have registered with the Collector by obtaining licence in Form S.P. XIV for this purpose
(3) All medicinal preparations containing alcohol or intoxicating drugs can be possessed or sold by registered dealers.
(4) All application for grant or renewal of a licence in Form S.P.XI or in Form S.P. XIV shall be made in Form S.P. XV which shall be duly stamped, to the Collector. On receipt of such application and after making the enquiry, if the Collector considers that the applicant is eligible for the licensee, he shall issue the licence. If on any account, the Collector considers it not necessary to renew a licence, he shall do so only after giving as opportunity to the licensee to represent his case. The Collector shall, in exercising his powers under the rule, have regard to the following considerations namely.:-
(a) whether the applicant has taken out the prescribed licence under the Drugs and Cosmetics Act, 1940 ( Central Act XXIII of 1940) or under the Medicinal and Toilet Preparations (Excise Duties) Rules 1956 or whether he is qualified to hold the licence;
(b) that the financial position of the applicant is sound;
(c) that there is actual need for such a licence at the locality: and
(d) that the applicant has not been convicted of any offence under the Act, Medicinal and Toilet Preparations (Excise Duties) Act, 1955 (Central Act 16 of 1955) Drugs and Cosmetics Act, 1940 (Central Act XXIII of 1940) or the Dangerous Drugs Act,1930 (Central Act II of 1930) or the Opium Act 1878 (Central Act II of 1878).
(e) The licences issues under these rules shall be biennial at the option of the licensee subject to the collection of appropriate renewal fee for two years. Applications for renewal either annual or biennial shall be made before the 31 st March of the year. If the application for renewal has been submitted before the expiry of the licence, then the licence shall be deemed to be in operation till orders are passed renewing or rejecting the renewal of the licence.
(f) In the case of applications for renewal made on or after the 1 st day of March and before the 31 st day of March, an additional fee of Rs.10 (Rupees ten only) Shall be levied. The application received after the 31 st day of March of the year to which the licence relates shall be treated as fresh application for a licence and dealt with accordingly.
(5) The Collector may, if he considers it necessary, consult the Director of Indian Medicines, the Drugs Controller or the Director of Medical services and Family Welfare, as the case may be, before sanctioning the issue of the licence.
(6) Any licence issued under this rule, shall be valid only in respect of preparations coming under any one of the following systems of medicine, namely, Allopathic, Ayurvedic, Siddha, Unani or Homeopathic as may be specified in the licence.
(7) The licence granted or renewed under this rule shall be valid for the financial year beginning on and from the 1 st day of April or from the date of issue of the licence ending on the 31 st day of March immediately following unless a shorter period is specified in the licence.
(8) (a) The holders of licences in Form S.P. XI and in Form S.P. XIV shall remit the security deposit at the rates specified below for the due observance of the terms and conditions of the licence:-
(1) For L1 manufactories Rs.1,000 (Rupees one thousand holding the licence in only) Form S.P. XI and S.P XIV
(2) For L2 manufactories Rs. 500 (Rupees five hundred Only) holding the licences in Form S.P. XI and S.P. XI and S.P.XIV
(3) For other dealers. Rs.250 (Rupees two hundred and fifty only)
(b) In case of non observance of the terms of licence, the security amount so deposited shall be forfeited to the Government without prejudice to the cancellation of the licensee provided that no forfeiture of deposit shall be made unless the licence has had reasonable opportunity of showing cause against such forfeiture. The forfeiture of the security deposit and the cancellation of the licence shall not be held to prevent the licensee from being proceeded against in a court of law under the provisions of the Act and the rules framed there under or any law for the time being in force.
9) The possession of a licence under the Drugs and Cosmetics Act, 1940 (Central Act XXIII of 1940) shall not be insisted upon for registration as a dealer under these rules for import and sale of cosmetics, if the cosmetics are of Indian origin and have been manufactured by licensed manufacturers.
(10) permanent numbers shall be assigned to the licence in Forms S.P.XI and S.P. XIV issued under rule 11.