Company : Sol Infotech Pvt. Ltd. Website : www.courtkutchehry.com BOMBAY DRUGS (CONTROL) (GUJARAT) RULES, 1961 CONTENTS CHAPTER 1 :- PRELIMINARY 1. Short title 2. Definitions CHAPTER 2 :- WHOLE SALE LICENCE 3. Application for whole-salers licence 4. Grant of whole-salers licence 5. Sale of notified drugs 6. Maintenance of accounts by licensed whole-seller CHAPTER 3 :- RETAIL LICENCE 7. Application for retailers licence 8. Grant of retailers licence 9. Sources of supply of notified drugs 10. Sale of notified drugs 11. Maintenance of accounts by licensed retailers 12. Application for a permit 13. Grant of permit CHAPTER 4 :- TRANSPORT OF NOTIFIED DRUGS 14. Application for a transport pass 15. Grant of transport pass CHAPTER 5 :- GENERAL 16. Duration of Licence 17. Sale at more than one place 18. Preservation of records 19. Inspection of stocks, accounts etc 20. Regulation of business of licence 21. Issue of duplicate licence, permit, or pass 21A. Fees for transfer of a licence from one site to another 21B. Fees for transfer of a licence from one name to another 21C. Fees for admission in or withdrawal from the business of a partner 21D. Fees for an amendment of a licence, permit, or pass 21E. Rounding off of fees 22. Licensee or permit holder to abide by the provisions of the Act, etc 2 3 . Maximum quantity of notified drugs to be possessed for purpose of sample 24. Form of sale Memorandum BOMBAY DRUGS (CONTROL) (GUJARAT) RULES, 1961 BOMBAY DRUGS (CONTROL) (GUJARAT) RULES, 1961 CHAPTER 1 PRELIMINARY 1. Short title :- These Rules may be called the Bombay Drugs (Control) (Gujrat) Rules 1961. 2. Definitions :- In these rules unless the context otherwise requires- (1) "the Act" means the Bombay Drugs (Control) Act, 1959: (2) "form" means a form appended to these rules: (3) "licence" means a licence granted under these rules; (4) "licensee" means a person who has been granted a licence under these rules: (5) "pass" means a pass granted under these rules: (6) "permit" means a permit granted under these rules; (7) "section" means a section of the Act: (8) words and expressions used but not defined in these rules shall have the meaning respectively assigned to them in the Act. CHAPTER 2 WHOLE SALE LICENCE 3. Application for whole-salers licence :- Any person desiring to carry on the business of a whole-saler in notified drugs and to possess such drugs for the purpose of his business shall apply, in Form 'N.D.A.' 1, to the Collector for a licence In that behalf. 4. Grant of whole-salers licence :- On receipt of an application under Rule 3, the Collector may, after making such enquiries as he deems necessary to verily or ascertain the truth of any statements made in the application, and after satisfying himself that there is no objection to the grant of the licence applied for, grant the applicant a licence in Form 'N.D.W.L.' on payment of a fee of rupees fifty. 5. Sale of notified drugs :- A licensed whole-saler shall not sell a notified drug to any person in the State of Gujarat- (a) who is not a dealer: (b) who is not a medical practitioner: (c) who is not authorised by the Collector under section 14; in any quantity exceeding that fixed under section 10 by the State Government as the maximum quantity which may in any one transaction be sold by such whole-saler. 6. Maintenance of accounts by licensed whole-seller :- A licensed whole-saler shall maintain in Form N.D.I., a register of daily accounts of all notified drugs obtained, possessed and sold by him and he shall enter therein true and complete details of the particulars specified therein. He shall, before the 7th day of every month, furnish to the Superintendent of Prohibition and Excise or the District Inspector of Prohibition and Excise of the area, as the case may be, a monthly return in Form N.D.2, in respect of notified drugs, obtained, possessed and sold by him in the previous month. CHAPTER 3 RETAIL LICENCE 7. Application for retailers licence :- Any person desiring to carry on the business of a retailer in notified drugs, and to possess such drugs for the purpose of his business shall apply in Form 'N.D.A. 1' to the Collector for a licence in that behalf. 8. Grant of retailers licence :- On receipt of an application under Rule 7, the Collector may, after making such enquiries as he deems necessary to verify or ascertain the truth of any statement made in the application, and after satisfying himself that there is no objection to the grant of the licence applied for, grant the applicant a licence in Form 'N.D.R.L.' on payment of a fee of rupees twenty five. 9. Sources of supply of notified drugs :- A licensed retailer shall not obtain notified drugs for the purpose of his business from any person in the State of Gujrat who is not a licensed whole- saler and except under a transport pass in Form N.D.T. 10. Sale of notified drugs :- A licensed retaller shall not sell a notified drug to any person in the State of Gujarat- (a) who is not a medical practitioner: (b) who is not authorized by the Collector under section 14: or (c) who is not holding a prescription issued by a medical practitioner: in any quantity exceeding that fixed under section 10 by the State Government, as the maximum quantity which may be sold in any one transaction by such retailer. 11. Maintenance of accounts by licensed retailers :- A licensed retailer shall maintain in Form N.D. 3, a register of daily accounts of all notified drugs obtained, possessed and sold by him and he shall enter therein true and complete details of the particulars specified therein. He shall before the 7th day of every month, furnish to the Superintendent of Prohibition or the District Inspector of Prohibition and Excise of the area, as the case may be, a monthly return in Form N.D. 2 in respect of notified drugs obtained, possessed and sold by him in the previous month. 12. Application for a permit :- Any person desiring to possess any notified drugs in excess of such quantity as has been at any one time dispensed or sold on prescription for a bonafide medicinal use to him or to a member of his household shall apply to the Collector In Form N.D.A.-2 for a permit in that behalf. 13. Grant of permit :- 0n receipt of an application under rule 12 the Collector may, after making such enquiries as he deems necessary to verify or ascertain the truth of any statements made in the application, and after satisfying himself that there is no objection to the grant of the permit applied for, grant the applicant a permit in Form N.D.P. on payment of a fee of Re. 1. CHAPTER 4 TRANSPORT OF NOTIFIED DRUGS 14. Application for a transport pass :- Where for the transport by any person of a notified drug, a transport pass is necessary, a person desiring to transport such notified drug shall make an application in Form N.D.A.-3 to an officer duly empowered by the State Government under Section 13 of the Act. 15. Grant of transport pass :- On receipt of the application under rule 14 the officer shall make such enquiries as he may deem necessary and if he is satisfied that there is no objection to grant the transport pass to the applicant, he may grant him a pass in from N.D.T. on payment of a fee of Re. 1. CHAPTER 5 GENERAL 16. Duration of Licence :- No licence or permit under these rules shall be granted for a period beyond 31st day of March next following the date of the commencement of the licence or the permit, as the case may be. 17. Sale at more than one place :- If notified drugs are intended to be sold by a dealer at more than one place, a separate licence shall be necessary in respect of each such place. 18. Preservation of records :- (1) Every dealer in notified drugs shall preserve the register of accounts of notified drugs and register of sale of notified drugs for not less than one year from the date of the last entry in the account book or the register of sale. He shall also preserve the delivery memoranda, invoices and cash memoranda relating to the sale or purchase of notified drugs or to the stock thereof, for a period of one year after the expiry of the year to which they relate. (2) Every medical practitioner and licensed retailer shall preserve for a period of one year after the expiry of the year in which a notified drug is supplied, every prescription under which the notified drug was supplied, or a copy thereof, if the prescription is returned to the person presenting it. Where copies of prescriptions are kept, the original shall, before being returned to the person presenting it, be endorsed, as to the drug dispensed or sold and the quantity thereof. 19. Inspection of stocks, accounts etc :- Every dealer or medical practitioner shall produce all books of accounts and documents relating to notified drugs together with the licence and the stocks of notified drugs that may be in his possession at that time for inspection on demand by the Director or the Collector or any officer duly authorised under section 31 and shall allow him to inspect and to take such copies or extracts as he thinks fit, of all such books of accounts and documents relating notified drugs which belong to or are under the control of such dealer or medical practitioner. 20. Regulation of business of licence :- (1) No person shall be recognised as a partner of the licensee for the purposes of his licence, unless the partnership has been declared to the Collector before the licence is granted and the names of the partners have been entered jointly in the licence, or if the partnership is entered into after the granting of the licence unless the Collector agrees on application made to him to after the licence and to add the name or names of the partner or partners In the licence. (2) The licensee shall carry on his business under the licence either personally or by an agent or servant duly authorised by him in this behalf, by a written nokarnama signed by himself and countersigned by a Prohibition and Excise Officer not lower in rank than a Sub-Inspector. For every such nokamama issued by the licensee and countersigned by the Prohibition and Excise Officer, the licensee shall pay a fee of rupee one: Provided that any such nokamama signed by the licensee shall be valid until counter-signature is refused. If for any reason the Collector shall order the withdrawal of any nokamama issued by the licensee, the nokamama shall be forthwith withdrawn. No nokamama shall be issued to any person who is a minor and no such nokamama, if issued, shall be valid. 21. Issue of duplicate licence, permit, or pass :- (1) If at any time a licence, permit or pass is lost by the licensee or the permit holder or is destroyed or is so torn or defaced in any way as to cease it to be reasonably legible, the licensee or the permit holder shall forthwith intimate the fact in writing to the Collector. (2) Upon in the receipt of such intimation, the Collector may after verifying the truth of the statements made in the intimation issue a duplicate licence or permit to the licensee or the permit holder. (3) When a duplicate licence or permit or pass is issued under sub- rule (2) it shall be clearly stamped 'Duplicate' in red and shall be marked with the date of Its issue. (4) In the case of a licence, permit or pass which is torn or defaced, the duplicate shall not be issued unless the licence or permit is returned by the licensee or the permit holder as the case may be, to the Collector. (5) The fee for a duplicate licence or permit or pass under this rule shall be Re. 1. 21A. Fees for transfer of a licence from one site to another :- The fee for the privileged of having the transfer of a licence from one site to another shall be ten percent of the fee charged for such licence: Provided that such fee shall in no case be less than rupee one. 21B. Fees for transfer of a licence from one name to another :- T he fee payable by any licensee, for the privilege of having a transfer of his licence from one name to another shall be the same as the fee charged for the grant of the licence. 21C. Fees for admission in or withdrawal from the business of a partner :- The fee payable by any licensee, for the privilege of allowing the admission of a partner or partners in, or the withdrawal of a partner or partners from, the business under his licence shall be 50% of the fee charged for the grant of the licence: provided that such fee shall in no case be less than rupee one. 21D. Fees for an amendment of a licence, permit, or pass :- The fee for the privilege of having an amendment made in the particulars entered in any licence, permit or pass granted under the Act on payment of a fee shall be rupee one per amendment. 21E. Rounding off of fees :- While recovering fees under rules 21- A to 21-D, any amount less than fifty paise shall be remitted and fifty paise or more shall be rounded to the extent of whole rupee. 22. Licensee or permit holder to abide by the provisions of the Act, etc :- The licensee or the permit holder shall abide by the conditions of the licence or the permit as the case may be, the provisions of the Bombay Drugs (Control) Act, 1959 and the rules and orders made thereunder and shall give an undertaking to that effect. 23. Maximum quantity of notified drugs to be possessed for purpose of sample :- The quantity of any notified drug that may be possessed by any person for the purposes of sample under section 16 shall not exceed four ounces. 24. Form of sale Memorandum :- The Sale memorandum which a dealer is required to give under sub-section (1) of section 17 shall be in Form N.D. 4.