RULES

BALOCHISTAN DRUGS RULES, 1983 BALOCHISTAN DRUGS RULES, 1983 [Gaz. of Bal. Ext., 20th October, 1983] No. SO-II(H) 14-1/82.--In exercise of the powers conferred by section 44, Drugs Act, 1976 (XXXI of 1976), the Government of Baluchistan, is pleased to make the following rules, namely:‑ PART I Preliminary 1. Short title and commencement.--(1) These rules may be called the Baluchistan Drugs Rules, 1983. (2) They shall come into force at once. 2. Definitions.--In these rules unless there is anything repugnant in the subject or context:- (a) 'Act' means the Drugs Act, 1976 ()OM of 1976). (b) 'Board' means the Provincial Quality Control Board for Baluchistan; (c) 'Form' means form specified in Schedule A; (d) 'Government' means the Government of Baluchistan. (e) 'Licensing authority' means the authority specified in rule 14; 1[(ea) "Narcotics and other control drugs" means the drugs specified in Schedule B. (eb) "Pharmacy" means a shop, store or a place where drugs are compounded or prepared on prescription; it shall include a place, which bears the words pharmacy; pharmacists shall conform to requirement laid down in Schedule E. (ec) "Veterinary" means shop, store or place where veterinary drugs are sold by way of retail sale/wholesale.] (f) 'Registered medical practitioner' means a medical practitioner registered under the Pakistan Medical and Dental Control Ordinance, 1962 (XXXII of 1962). (g) 'Retail sale' means sale other than sale by way of whole sale dealing; (h) 'Schedule' means a Schedule to these rules; (i) 'Section' means section of the Act; (j) 'Whole sale' means sale to a person who buys for the purpose of selling again and includes sale to a registered medical practitioner, hospital dispensary or any institution; (k) 'Appellate Board' means the Provincial Appellate Board. ____________________________________ 1. In rule 2, after clause (e) the following new sub-clauses added by No. SO (ADMN)H/2- 4/2007/4662-716, dated 26.2.2007. [Gazette of Balochistan Extraordinary 26th February, 2007]. [PLD 2009 St. P. 235. PART II Provincial Quality Control Board Government Analyst and Provincial Drug Inspector 3. Provincial Quality Control Board.--(1) The Board shall consist of the following member, namely:‑ 2[(a) "Chairman" as Government appoints from time to time.] (b) an officer of the Provincial Drugs Administration who shall, as far as possible, be a pharmacy graduate. (c) one member from the pharmacy profession who shall be at least graduate in pharmacy to be nominated by Government having no financial interest in pharmaceutical trade and industry; (d) one pharmacologist to be nominated by Government having no financial interest in pharmaceutical trade and industry; and (e) Secretary, Provincial Quality Control Board, who shall be pharmacy graduate to be appointed by Government and registered in Register A by the Pharmacy Council with minimum B-Pharamcy degree. (2) The Board may co-opt a legal advisor or an Advocate, the Inspector, the Government Analyst concerned and where considered necessary, specialist in the field concerned for technical examination of a case. (3) The Board may also co-opt any other qualified expert having formal training and experience in the pharmaceutical field. (4) The members of the Board may elect from among themselves a Vice-Chairman who shall function as Chairman in the absence of the Chairman. (5) The nominated members of the Board shall hold office for three years and shall be eligible for re-nomination. ______________________________________________ 2. Clause (a) of sub-rule (1) of rule 3 shall be substituted by No. SO (ADMN)H/2-4/2007/4662-716, dated 26.2.2007. [Gazette of Balochistan Extraordinary 26th February, 2007]. [PLD 2009 St. P. 109]. (6) The quorum to constitute a meeting of the Board shall be three including its Chairman. (7) No act or proceeding of the Board shall be invalid merely on the ground of the existence of any Vacancy in, or any defect in the constitution of the Board. 4. Procedure of the Board.-(1) The Inspectors and Analysts shall submit monthly returns in Form 1 and Form 2, respectively, to the Board and a summary on the overall situation of quality control in the area under the respective jurisdiction; and the Board shall maintain such information in a manner so as to minitor the s quality of all the drugs sold and to keep watch on the performance of all manufacturers. (2) The Board shall as far as possible, meet at least once in a month and review the situation of the quality control of drugs on thee whole, including consideration of any specific point arising during the period, on working of various firms, drug testing laboratories and Inspectors. (3) The Board shall examine carefully the case referred to it by any Inspector under the Act and provide an opportunity of hearing to the accused to explain his position before directing the Inspector to prosecute the accused. (4) Before referring any case to the Drug Court, the Board shall ascertain the names of the Directors, partners and employees of the company, corporation firm or institution who are prima facie responsible for the commission of the offence under the Act, or, the rules and allow an Inspector to institute prosecution' only against such person. (5) Where a drug is found to be substandard or adulterated, the Board before referring the case to the Drug Court, on the request of the accused, shall cause the sample of the Drug lying with the Board concerned under subsection (3) of section 19 to be sent for test or analysis to the Federal Drug Laboratory or any other Laboratory specified for the purpose by the Federal/Provincial Government, which shall make the test or analysis and report, in writing signed by or, under the authority of, the person for the time being incharge of the Federal Drug Laboratory, or, as the case may be, such other laboratory, the result thereon and such report shall be conclusive evidence of the facts stated therein. (6) On receipt of the test report from the drug laboratory, a copy of the test along with method of analysis (Protocol of test), shall be conveyed to the dealer. (7) The Board may, in case of minor offences, in its discretion, advice the accused to bring improvement or if considered necessary, issue a warning to the accused and take other action including recall of the batches. 5. Qualifications, etc. of Provincial Inspector and Provincial Government Analysts.--(1) No person shall be appointed as a Provincial Inspector unless he shall possess a decree in pharmacy from a Pakistan University or any other institution recognized for this purpose by the Pharmacy Council of Pakistan and " be registered in Register A with minimum B pharmacy Degree and has at least one year's experience in the manufacture, sale, testing or analysis of drugs or in the Drugs Control Administration or in a hospital or pharmacy. (2) No person shall be appointed as a Provincial Government Analyst unless he possesses a degree in pharmacy from Pakistan University or any other institution recognized for this purpose, by the Pharmacy Council of Pakistan and must be registered in Register 'A. and he has at least three years' experience in the testing or analysis of drugs or in the Drugs Control Administration: Provided that if a person of the requisite qualifications is not available, a person possessing degree in Medicine or Master's Degree in Pharmaceutical Chemistry, or pharmacology with three years' experience in testing of chugs and medicines in public health laboratories may be appointed: Provided further that the provisions of these rules shall not apply to the Inspectors and the Analysts who were appointed as such on a regular basis before the coming into force of these rules. (3) The Government may, by notification in the official Gazette, appoint a person possessing a degree in pharmacy, Medicine or a Master Degree in pharmaceutical Chemistry or Microbiology or pharmacology as an ex officio Inspector from amongst its officers working in the Drugs Administration, or, in any other recognized pharmacy or medical institution, who otherwise does not fulfil the qualifications laid down in sub-rule (1): Provided that the ex-officio Inspector shall be appointed for the purpose of: (i) conducting inspection of any premises wherein any drug is sold or is stocked or exhibited for sale or is distributed, and seeing the storage (ii) arrangements and all relevant record and registers; and (iii) taking samples of any drug which is being sold or is stocked or exhibited or sold or is being distributed. (4) The Government may, by notification in the official Gazette, for the exercise of such powers as may be specified in the notifications appoint as ex officio Analyst any person who holds a degree in Pharmacy or Medicine or a Master's Degree in Pharmaceutical Chemistry or Microbiology or Pharmacology and is engaged in testing laboratory or in a Chemical Examiner's Laboratory or is working in a Pharmaceutical or Medical Educational or Research Institution. 6. Duties of Inspectors.--Subject to the instructions of the licensing authority, it shall be the duty of an Inspector:- (a) to inspect not less than twice a year all establishments of drugs licensed for sale and once a year all establishment licensed for manufacture of drugs within the area assigned to him, and to keep record of such inspections; (b) to satisfy himself that the conditions of the licences are being observed; (c) to take and. send for test or analysis, if necessary, samples of any drug which he has reason to suspect is being manufactured or sold or stocked or exhibited for sale in contravention of any of the provisions of the Act or these rules; (d) to investigate any complaint in writing which may he made to him and furnish the report in respect of to the licensing authority; (e) to institute prosecution in respect of contravention of the Act and these rules; (f) to maintain record of all inspections made and action taken by him in the performance of his duties, including the taking of sample and the seizure of stocks and submit reports of such record, as may he required by the licensing authority; and (g) to make such enquiries and inspections as may be necessary to stop manufacture and sale of drugs in contravention of the Act, and these rules. 7. Prohibition of disclosure of information.--Except for the purpose of official business or when required by a Court of law, an Inspector or an Analyst shall not disclose to any person any information acquired by him in the course of his official d ties. 8. Form of order not to dispose of stock.--An order in writing by an Inspector under clause sub-section (1) of section 18 requiring a person not to dispose of any stock in his, possessions shall be in Form 3. 9. Form of intention for purpose of taking samples.--(1) Where a Provincial Inspector takes a sample of drug under clause (c) of sub-section (1) of section 18 of the purpose of test or analysis, he shall intimate such purpose in writing in Form 4 to the person from whom he takes it and where he seizes stock or a drug or other material under clause (f) of section 18 the receipt for such drug and material shall be in Form 5. (2) The Provincial Inspector shall send a portion of the sample or the container to the Government analyst for test or analysis under clause (i) of sub section (3) of section 19 through a memorandum in Form 6. (3) In case the sample is delivered to the Government Analyst by an indirect means such as post, a coyp of the memorandum, a specimen impression of the seal, or mark used to seal the packet, shall be sent to the analyst separately by registered Post or by hand. 10. Duties of Government Analyst.--(1) A Government Analyst shall cause t0 he analyzed or tested such samples of drugs as may be sent to him under the Act and shall furnish reports of the result of test along with protocol of test and analysis accordance with the Act and these rules. (2) A Government Analyst shall cause to be tested and analyzed such sample as may be sent to him in writing from a Government Department or any other Public institution and shall furnish the report of the result of test and protocol of test (method of analysis) to the Department or the public institution concerned. (3) A Government Analyst shall forward monthly reports giving results of samples tested and analysed during the period under report with a view to their publication at the discretion of the Federal Government and furnish such other information as may be required by that Government. 11. Procedure on receipt of samples from Inspector.--On receipt of a package from an Inspector containing a sample for test and analysis the Government Analyst shall compare the seals on the packed with the specimen impression received separately and shall note the condition of the seal on the package and after the test or analysis has been completed, he shall forthwith supply to the Inspector a report of the result of the test and analysis with protocols in Form 7. 12. Fee for test and analysis of drugs.--(1) The fee for test and analysis of drugs in respect of samples sent by persons other than an Inspector or a Government institution, shall be determined by the Analyst or the person Incharge of the Government laboratory in accordance with the fees specified in the Schedule 'C'. 13. Payment of cost of samples.--As provided under section 18(a) of the Drugs Act, the payment of the cost of samples taken by the Inspector of Drugs, may be arranged out of the Government funds, on the availability of funds. PART III Sale of Drugs 14. Licensing authority.--(1) The Secretary to the Government in the Health Department shall be the licensing authority for the purpose of these rules. The licensing authority may, by order in writing, authorize any person under its control to sign the licences and to exercise such other powers, and in respect of such areas, as may be specified in the order. 15. Types of licences to sell drugs.--The licences under these rules shall be of the following types, namely:-- (i) licence to sell drugs by way of retail sale; (ii) licence to sell drugs by way of wholesale; 3[(iii) License to sell narcotics and other control drugs; (iv) License to sell in Pharmacy/Veterinary.] 16. Application for licence to sell drugs and fees thereof--(1) Application for the grant or renewal of any licence referred to in clauses 4[(i), (ii), (iii) and (iv)] of rule 15 shall be made in Form 8 to the licensing authority and shall be accompanied by a fee of:---- _____________________________________________________ 3. In rule 15, after sub-clause (ii), the following new sub-clauses (iii) & (iv) shall be added by No. SO (ADMN)H/2-4/2'007/4662-716, dated 26.2.2007. [Gazette of Balochistan Extraordinary 26th February, 2007]. [PLD 2009 St. P. 109]. 4. In rule 16 in sub rule (1) the bracket and figure (i) to (ii) appearing after the word "clauses" shall be substituted by the bracket and figure (i), (ii), (iii), (iv) by No. SO (ADMN)H/2-4/2007/4662-716, dated 26.2.2007. [Gazette of Balochistan Extraordinary 26th February, 2007]. [PLD 2009 St. P. 1091]. 5[(a) "A fee of Rs. 5000 for grant of a retail sale license and Rs. 10000 for grant of a whole sale License." (b) "A fee of Rs. 2500 for renewal of a retail sale license and a fee of Rs. 3000 for renewal of a whole sale license.] (2) The licence may be renewed, if the provisions of these rules have been complied with and the requirements specified in Form 8 are fulfilled. (3) 6[A fee of three thousand rupees] shall be paid for any change of proprietary or qualified person or a duplicate copy of the licence, if the original is defected, damages or lost, and such copy of the licence shall bear the words "duplicate copy". 17. Forms of licences to sell drugs.--(1) A licence to sell, stock, exhibit for sale or distribute drugs by way of retail sale, shall be issued in Form 9. (2) A licence to sell, stock, exhibit for sale or distribut drugs by way of wholesale shall be issued in Form 10. 7[(3) A license to sell, store, exhibit Narcotics and other controlled drugs for sale or distribute as specified in Schedule B, shall be in Form. II. (4) A license to sell drugs in pharmacy/veterinary, shall be in Form-12.] 18. Sale at more than one place.--If drugs are sold, stocked, exhibited for sale or distributed at more than one place or godown, the licence shall notify alongwith application for grant of licence, the premises which shall be used by him as godown and the Provincial Rule making authorities shall be empowered to visit and Inspect such godowns. 19. Duration of licences.--(1) A licence issued under these rules shall, unless sooner suspended or cancelled, remain in force for two years from the date of issue and if an application for renewal of licence is not made within one month of the expiry of the licence, the licence shall be stand cancelled: Provided that if application for renewal of a licence is made before the expiry of the period of validity of the licence, or where it is not done so, for reason beyond the control of the licencee and the application is made within one month of the expiry of licence, the licence shall continue to be in force until orders are passed on the application: Provided further that sections 5 and 12 of the Limitation Act, 1908 shall be applicable in the matter of renewal of licence. _________________________________________________ 5. For sub-clauses (a)&(b) shall be substituted by No. SO (ADMN)H/2-4/2007/4662-716, dated 26.2.2007 [Gazette of Balochistan Extraordinary 26th February, 2007]. [PLD 2009 St. P. 109]. 6. In sub-rule (3) for the words "A fee of fifty rupees" substituted by No.' SO (ADMN)H/2- 4/2007/4662-716, dated 26.2.2007. [Gazette of Balochistan Extraordinary 26th February, 2007].[PLD 2009 St. P. 109.] 7. After sub-rule (2) the following new sub-rules (3) & (4) by No. SO (ADMN)II/2-4/2007/4662-716, dated 26.2.2007. [Gazette of Balochistan Extraordinary 26th February, 2007]. [PLD 2009 St. P. 109], (2) An application for grant of renewal shall he disposed of within three months of the receipt of such application. (3) The authority to whom the licensing authority has delegated powers to issue or renew Drugs Sale licences, shall submit monthly report to the licensing authority on the following subjects:‑ (a) Name and address of the applicant who submitted application for issue/renewal of licence. (b) Date of receipt of application. (c) Number of application disposed of:‑ (i) Granted Number Date (ii) Renewed Number Date (iii) Suspended Number Date (iv) Cancelled Number Date (v) Reasons for suspension cancellation of licence. (vi) Reasons for delay in disposal of application within the specified period of 3 months. 8[(4) The license issued under sub-rules (3) and (4) of rule 17 shall be subject to sub-rule (1) of Rule 19 of these rules.' 20. Pre-conditions for the issue of licence.--(1) The licensing authority 4 shall not issue- (a) licences in Form 9 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, where necessary, for preserving the properties of the drugs; (ii) the premises are clean and in hygienic and tidy condition. (b) licences in Form 10 unless the applicant is an indentor, importer, manufacturer or distributor of a manufacturer and fulfils the conditions laid down in sub-clauses (i) and (ii) of clause (a); (c) The applicant has never been convicted of any offence under the Act; 9[(d) License in Form-II, unless the applicant possesses a license in Form-9 or Form-10 or Foram-12 and fulfils the conditions laid down in sub-clauses (i) and (ii) of clauses (a) and (c) of sub-rule (1) of Rule 20.] (2) The sale of drugs shall be supervised:- ______________________________________________ 8. After sub-rule (3) the following new sub-rule (4) added by No. SO (ADMN)11/2-4/2007/4662-7169 dated 26.2.2007. (Gazette of Balochistan Extraordinary 26th February, 20071. 1P1.1) 2009 St. P. 109]. 9. After sub-clause (c) of sub-rule (1), the following new sub-clause (d) shall be added by No. SO (ADMN)11/2-4/2007/4662-716, dated 26.2.2007.[Gazette of Balochistan Extraordinary 26th February. 2007]. [PLD 2009 St. P. 109]. (a) under licence in Forms 9 and 10 by a person who is registered under clause (a) or clause (b) of sub-section (1) of section 24 of the Pharmacy Act, 1907 (XI of 1967): Provided that the persons of the following categories may also be approved as qualified persons for the grant of licence, in Forms 9 and 10‑ (i) a person who was approved as qualified person for the grant of Drugs (sale) licence under the West Pakistan Drugs Rules, 1958; or (ii) a person who was on the 19th day of June, 1972, qualified for registration under clause (h) of sub-section and registered in Register B by Provincial Pharmacy Council; or (iii) a person who has, before the commencement of these rules, passed the examination of compounders or dispensers and has completed two years period of apprenticeship under clause (c) of the aforesaid sub section. 21. Conditions of licences.--(1) Licences in Forms 10[9, 10, 11 and 12] shall he 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 shall he recorded, suitable such records, bills, or counterfoils, shall be preserved for a period of at least three years from the date of such sale; (b) the drugs specified in Schedule 11[13 `17,1 shall not be sold by retail sale except on and in accordance with the prescription of a registered medical practitioner: Provided that no such prescription shall be required for sale of these drugs to a registered medical practitioner, 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 the Schedule "E' by way of retail sale, shall he recorded at the time of sale in a register specially maintained for the purpose and at 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) Serial Number. (ii) Date of Sale. (iii) Name of the prescriber. (iv) Name of the patient/purchaser. (v) Name of the drug. (vi) Name of the manufacturer. (vii) Quantity. (viii) Batch No. . (ix) Signature of the qualified person: __________________________________________________ 10. In rule 20, the sub-rule (1) subs. for the word the figures "9 and 10" by No. SO (ADMN)11/2- 4/2007/4662-716, dated 26.2.2007. [Gazette of Balochistan Extraordinary 26th February, 2007] [PLD 2009 St. P. 109]. 11. In rule 20 in sub-clause (b) for the word "E" substituted by No. SO (ADMN)I1/2-4/2007/1662-716, dated 26.2.2007. [Gazette of Balochistan Extraordinary 26th February, 2007]. [PLD 2009 St. P 109]. Provided that if the drug specified in Schedule `E' 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 Sr. No. the date of the sale, the quantity sold, and a sufficient reference to any entry in the register recording the dispensing of the drug on a pre 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; (b) specify the name and address of the person for whose treatment it is given; and (c) indicate the total quantities of drugs to be supplied and doses to be taken. (3) All invoices and bills of purchasers of drugs shall be preserved for a period of at least three years. (4) Records shall be maintained of all purchases and sales of drugs by way of wholesale and such records shall be preserved for three years except where an expiry date is specified in which case the records shall be preserved for three years from the date of expiry and shall include the following particulars, namely:- (a) the date of purchase and sale; (b) the name and address of the concern from which purchase and the concerns applicable, and the quantities; and (c) the name of the manufacturer. (5) Except as otherwise provided in these rules all registers and records maintained under these rules, shall be preserved for a period of not less than three years from the date of the last entry. (6) The licensee 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. (7) The licensee shall maintain the Inspection Book provided by the licensing authority at the time of issuance or renewal of the licence on which any member of the Board or an Inspector shall record proceeding of each of his visit, his impression and the defects or irregularities noticed, if any, by him and such Inspection Book shall be signed by him as well as the licensee or the qualified person. (8) Substances falling under Schedules `E' and 12[13] and shall be stored in the retail shop:-- (a) in a part of the premises to which customers do not have access; or (b) in an almirah or cupboard or drawer reserved solely for the storage of such drugs. (9) Substances falling under the list of poisons mentioned in Schedule 13[E] shall be stored in containers imperious 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 poisons when compounded and dispensed shall be labelled with the word 'Poison'. 22. Cancellation and suspension of licences.-14[***] The licensing authority may, on the report of an Inspector or on its own motion, after giving the licensee an opportunity to show cause by an order in writing stating the reasons therefor, cancel a licence issued under these rules or suspend it for such period as it thinks fit, either wholly or in respect of some of the drugs to which it relates, if in its opinion the licensee has failed to comply with any of the conditions of the licence or with any of the provisions of the Act or these rules wl)F-r1 the offence is of serious nature. 15[(2) **************] 16[23. Provincial Appellate Authority: (1) Any person aggrieved by an order of the Licensing Authority may prefer an appeal to the Provincial Appellate Authority within sixty days of the date of such order. (2) The Additional Chief Secretary, Balochistan shall be the Provincial Appellate Authority for the purpose of hearing appeals against the order of Licensing Authority and for this purpose he may coordinate any person having experience in the relevant field. (3) The Provincial Appellate Authority shall, after giving the appellant an opportunity of being heard pass such order as it thinks fit and such order shall be final. Note.-For Schedule A to D please see Gazette of Baluchistan Extraordinary, 20th October, 1983 (No. 338). ___________________________________________________________ 12. Subs. for the words "F" by No. SO (ADMN)H/2-4/2007/4662-716, dated 26.2.2007. [Gazette of Balochistan Extraordinary 26th February, 2007]. [PLD 2009 St. P. 109]. 13. Subs. for the words "F" by No. SO (ADMN)11/2-4/2007/4662-716, dated 26.2.2007. [Gazette of Balochistan Extraordinary 26th February, 2007]. [PLD 2009 St. P. 109]. 14. In sub rule (1) the bracket and figure (1) omitted by Notifi. No. SD (Admn.) 2-4/10429-10504, dt. 30.5.2005. [PLD 2009 Supp. II P. 64 [Gazette of of Balochistan, Extraordinary, 30th May, 2005]. 15. Sub-rule deleted by Notifi. No. SD (Admn.) 2-4/10429-10504, dt. 30.5.2005. [PLD 2009 Supp. II P. 64 [Gazette of of Balochistan, Extraordinary, 30th May, 2005]. 16. After rule 22 the folloiwng new rule 23 added by Notifi. No. SD (Admn.) 2-4/10429-10504, dt. 30.5.2005. [PLD 2009 Supp. II P. 64 [Gazette of of Balochistan, Extraordinary, 30th May, 2005]. ***