Part III 14.

Licensing authority: (1) the secretary, health department, shall be the licensing authority for the purposes of these rules. (2) The licensing authority may by order in writing authorize any person under its control to sign the license and to executrices such other powers, and in respect of such areas, as may be specified in the order. 15. Types of licenses to sell drugs: the licenses under these rules shall be of the following types namely:I license to sell drugs by way of retail sale: Ii license to sell drugs by way of wholesale: Iii license to sell narcotics, and other controlled drugs; and IV license for pharmacy 16 applications for license to sell drugs and fees thereof; Application for the grant or renewal of a license referred to in clause (me) and (IV) of rule 15 shall be made in form 8 to the licensing authority. (2) An application under sub- rule (1) shall be accompanied by a fee in head of account no. 1252 health other receipt. (A) two hundred rupees for the grant of license to sell either of the drugs specified in clauses (I) to (IV) of rules 15 and (B) one hundred rupees in case of renewal of such license subject to the condition that the provisions of these rules have been compiled with. (3) A fee of fifty rupees shall be paid for a change of qualified person and duplicate copy of the license referred to in clauses (I) to (iv) of rules 15 if the original defaced, damaged or lost and such copy of the license shall bear the words duplicate copy. (17) Forms of licenses to sell drugs; (1) a license to sell, store, and exhibit for sale or distribute drugs by way of retail sale shall be issued in form 9. (2) A license to sell, store, exhibit for sale or distribute drugs by way of whole sale shall be issued in form 10 (3) A license to sell, store, exhibit for sale or distribute narcotics, and other controlled drugs shall be issued in form 11.

(4) A license to sell drugs in pharmacy shall be in form 12. 18. Sale at more than one place; if drugs are sold, stored, exhibited for sale or distributed at more than one place, a separate license shall be required in respect of each place: 19. Duration of licenses: (1) a license issued under these rules shall unless suspended or cancelled earlier, remain in force for two years from the date if issue. And if an application for renewal of such license is not made within one month of its expire the license shall stand cancelled: Provided that if an application for renenewal of a license is made before the expiry of the lierne and the application is making with one month of the license, the line shall continue to be in force until orders are passed on the application. (2) (I) an application for a drugs sale license or renewal of a license shall be disposed of within 45 days of the reap of such application. (ii) No new drugs sale license shall vet issued without an inspection report from the inspector concerned. 20. Pre-condition for the issue of license: (1) the licensing authority shall not issue:(a) Licenses in form 9 and 12 unless(I) the premises have proper and adequate facilities for storage of drugs and for their protection from direct sunlight, dust or dirt including refrigeration facilities: (ii) The premises are clean and in hygienic and tidy condition; and (iii) In the case of a pharmacy, the requirements laid down in schedule F. (b) License in form 10 unless the applicant is an importer, manufacture, distributor or whole salver of drugs and fulfils the conditions laid down in sub clause(c) License in form 11 unless(i) (ii) The applicant posses a license in form 9 or form 10 form 12; and The applicant has never been convicted and sentence to pay Rs. 5000 or more as fine under section 27 (1) of the drugs act , 1976 for selling any spurious or unregistered drugs of for selling drugs without a drugs sale License.

Provided that for the purposes of clause 20 (a) (I) in remote areas where electricity families are not available, an ice box may be kept instead of a refrigerator.

(2) The sale of drugs shall be supervised under license in forms 9, 10, 11 by a person who is registered under section 24 (1) (a) license in form 12 shall be supervised by a person who is registered under section 24 (1) (a) of these rules. 21. Conditions of licenses; (1) licenses in forms 9, 10, 11 and 12 shall be issued subject to the conditions stated therein and to the following general conditions, namely (a) The supply by way of retail sale of any drug is recorded suitably and such records, bills or counterfoils shall be preserved for a period of at least five years from the date of such sale: (b) Drugs specified in schedules B and D and preparations containing such drug shall not be sold by retail sale, except on and in accordance with the prescription of a practionar registered with Pakistan medical and dental council. A prescription shall be dispensed only once, unless or otherwise specifically directed by the prescriber to repeat it: Provided that no such prescription shall be required for sale of these drugs to a registered medical practioner, hospital dispensary or any other institution approved by an order of the licensing authority for such sale. (c) the sale of any drug specified in schedules B and D by way of retail sale shall be recorded at the time of supply in a register specially maintained for purpose and the serial number of the entry in the register shall be entered in the prescription and the following particulars shall be entered in the register namely:(I) S. No (ii) Date of sale Name of the prescriber Name of the patient/ purchaser. Name of the drug Name of the manufacturer Quantity Batch no Signature of the qualified person Provided that if the drug specified in schedule D is sold on a prescription on which the drug has been sold on a previous occasion. It shall be sufficient if the entry in the register includes S. No. the date of sale, the quantity sold and a sufficient reference to an entry in the register recording the dispensing of the drug on a previous occasion. (2) For the purpose of this rule, a prescription shall:(a) Be in writing and be signed by the person giving it with his usual signature and be dated by him. (c) Indicate the total quantities of drugs to be supplied and doses to be taken. (3) All invoices and bills of purchase of drugs shall be preserved for a period of at least five years.

(iii) (iv) (v) (vi) (vii) (viii) (ix)

(4) (A) (I) in case of sale of drugs by way of wholesale by manufactures or their authorized agents. They must invariably ensure that the purchaser holds a valid drug sale license or is registered medical practitioner and shall issue an invoice inspector of the area concerned. (ii) The registered medical practioner and doctors of veterinary medicine shall be exempted from the requirement of drug sale license for the storage of drugs. Provided that (i) The drugs are dispensed to their own patients (ii) The drugs are not sold across the counter and (iii) The record of the drugs specified in schedule B is maintained as prescribed under rule 21 (1) (c) (viii) of these rules (iv) (b) Similarly the wholesaler while selling drug to a retailer must also invariably ensure that the retailer holds a valid drug sale license as required as required under the act and these rules Aden shall issue an invoice and warranty at the time of sale of drugs. (c) The invoice and warranty must bear the full name and address of the purchaser and shall be signed by the warrantor clearly indicating his name and must be dated. (5) records shall be maintained of all purchases and sales of drugs by the way of wholesale, and such records shall be preserved for five years and shall include the following characters namely:(a) The date of purchase and sale (b) The name and address of the concern from which purchased and the concerns to whom sold. (c) The names of the drugs their batch number their dates of expiry where applicable and the quantities and (d) The name of the manufactures (6) Except as otherwise provided in these rules. All registers records maintained under these rules shall be preserved for a period of not less than five years from the date of last entry. (7) The license shall produce for inspection by an inspector on demand all registers and records maintained under these rules, and shall supply to the inspector such information as he may require. (8) Substances specified in schedule E and failing under the list of poisons and those specified in Schedule B shall be stored in the retail shop (a) In a part of the promises to which customers do not have access or (b) In an Alma rah or cupboard or drawer locked, and reserved solely for the storage of such drugs.

(9) Substances falling under the list of poisons in schedule E shall be stored in containers, impervious to the poison and sufficiently stout to prevent leakage arising from the ordinary risks of handling and transport. (10) A substance falling in the list of poison under schedule E when compounded and dispensed shall be labeled with poison 22. Cancellation and suspension of licenses (1) the licenses authority may on the report of a provincial inspector or the board after giving the license an opportunity to show cause bye an order in writing stating the reasons therefore cancel a license issued under these rules or suspend it for such periods as it thinks fit. If in its opinion the license has failed to comply with any of the conditions of the license or with any of the provisions of the act or these rules. (2) A license whose license has been cancelled or suspended may appeal t o appellate board with in sixty days of the date of such order