DRUGS SALES LICENSE

DRUGS SALES LICENSE

The Provincial Government is authorized under section 6 of Drugs Act 1976 to regulate the sale of drugs in the province. In exercise of the powers conferred under section 44 of this Act, the Government of the Punjab has notified Punjab Drug Rules, 1988.

The Secretary to the Government of the Punjab, Health Department is the Licensing Authority. However he has delegated his powers to Executive District Officer (Health) at District level for public convenience, speedy and timely disposal of Licenses.

PROCEDURE

The application for grant of new license is received in the office of Executive District Officer’s (Health) on prescribed form No.8, available free of cost.

The licenses are of four types

•License No.9. For retail sale.

•License No.10. For wholesale.

•License No.11. For sale of narcotics, and other controlled drugs.

(Persons convicted of Rs 5000/- or more for sale of drugs without license and / or under section 27(1) of the Drug Act 1976 are not eligible for the grant of License.

•License No 12. For establishment of Pharmacy. (Only issued to Graduate Pharmacist registered in Category-A).

The application for grant of license shall accompany with following documents:

™Original bank challan receipt for fee of Rs.600/- per license deposited in Head of Account No.1252-Health, other receipt.

™Original registration certificate of qualified person alongwith valid renewal certificates from Punjab Pharmacy Council or Punjab Medical Faculty in case of dispenser with 4 years experience.

™Attested copies of I.D Card of Proprietor and Qualified person.

™Four Photographs of Qualified person and proprietor (each).

™Affidavit of Proprietor and Qualified (specimen available from the office of Executive District Officer (Health).

™Documentary evidence of ownership or tenancy certificate of the premises.

™Location map of shop and go-down.

™Bank draft of Rs.50/- for verification of dispenser certificate (if applicable).

™Authority letter for distribution from the concerned Pharmaceutical Manufacturing Firm in case of license No.10.

™Purchase receipt of Refrigerator.

¾The applicant shall ensure the cleanliness, hygiene and adequate facility for storage/ protection of drugs from direct sunlight, dust or dirt

¾The applicant shall ensure the fulfilment of requirements for Drugs Sale License No.12 provided in schedule (F) of the Drug Rules, 1988.

¾The Drug Sale License is valid for one premises only. However the licensee can change his premises by submitting an application to Executive District Officer (Health), but no sale is allowed without the change of address on the Drug Sale License.

¾Qualified person can be changed on an application to Executive District Officer (Health) on payment of Government fee of Rs 50/-

¾Duplicate license can be obtained from the concerned Executive District Officer (Health) after depositing Government fee.

¾The licenses are valid for two years unless suspended/ cancelled earlier.

¾The application for renewal is submitted to Executive District Officer (Health) before expiry of license. However, one-month grace period is allowed

¾The Executive District Officer (Health) office shall dispose off application for grant/renewal Drug Sale Licenses within 45 days after receipt.

¾The Drug Sale licenses may be suspended or cancelled on any contravention of Drug Act 1976 and Rules framed there under, after issuance of show cause notice and personal hearing of the Licensee.

Punjab Drugs Rules, 1988

FORM 8 [See rule 16 (1)]

Application for a licence to sell stock and exhibit for sale and distribute drugs

I/We………………………………………of………………………………………………………………………

………

hereby apply far a lincence to self. 1.Drug by way of retail sale. 2.Drugs by way of wholesale. 3.Narcotic and other drugs. 4.Drugs in Pharmacy.

On the premises situated.

2.The sale of drugs will be under the personal supervision of

(Name)___________________	(Qualification) _______
(Name)___________________	(Qualification) _______

3.I/We am/are submitting herewith the following documents.

Evidence of being importer/indenter/manufacturers, agent/distributor, etc.

Testimonials of qualified person.

Treasury Challan(s) for Rs……………………..

Date…………………..

Delete whichever in not applicable

Signature

Name of Owner

and Permanent Home Address.

Punjab Drugs Rules, 1988

SCHEDULE’F’

[See Rule 2 (f) and 20 (a)(iii)]

LIST OF MINIMUM REQUIREMENTS FOR A PHARMACY

I.Entrance: The front of a pharmacy shall bear an inscription “pharmacy”.

II. Premises: the premises of pharmacy shall be separated from room for private use. The premises shall be well built, dry, well lit and ventilated and of sufficient dimensions to allow the goods in stock, especially drugs and poisons to be kept in clearly visible and appropriate manner. The area of the section to be used at dispensing department shall not be less than 6 Sq. Meters for one person working therein with additional 2 Sq. meters for each additional person. The height of the premises shall be at least 2.5 Meters.

The floor of the Pharmacy shall be smooth and washable. The walls shall be plastered or tiled or oil painted, so as to maintain smooth, durable and washable surface devoid of holes, cracks and crevices.

A pharmacy shall provided with ample supply of good quality water.

The dispensing department shall be separated by barrier to prevent the entry of the public.

III. Furniture and Apparatus: the furniture and apparatus of Pharmacy shall be adopted to the sues for which they are intended and correspond to the size and requirements of the establishment.

Drugs and chemicals shall be kept in a room appropriate to their properties and in such special containers as will prevent any deterioration of the contents or of the content of containers kept near them. Drawers, glasses and other containers use for keeping medicaments shall be of suitable size and capable of being closed tightly to prevent the entry of dust.

Every container shall bear label of appropriate size, easily roadable, with names of medicaments as given in the pharmacopoeias.

A pharmacy shall be provided with a dispensing bench the top of which shall be covered with washable and impervious material like stainless steel laminated or plastics, etc.

A pharmacy shall be provided with a cupboard with lock and key for the storage of poisons and shall be clearly marked with the word “Poison” in red letters on a white background.

Containers of all concentrated solution shall bear special label of marked with the words” to be diluted”. A pharmacy shall be provided with the following minimum apparatus and books necessary for making of

official preparation and prescriptions. Apparatus

Balances dispensing sensitivity 30 mg. Balances counter, capacity 3 Kg. Sensitivity 1 g. Beakers lipped, assorted sizes.

Bottles, prescription, ungraduated assorted sizes. Coric extractors.

Evaporating dischos, porcelain. Filter paper.

Funhels, glass.

Litmus paper, blue and red.

Measure glasses, cylindrical, 10 ml, 25 ml. 100ml, and 500ml. Mortars and pestles glass.

Mortars and pestles, Wedgwood. Ointment slab, porcelain,

Pipetres graduated, 2ml, 5 ml and 10 ml. Ointment pot with Bakelite or suitable caps. Ring stand (retort) iron, complete with rings. Rubbers stamps and pad.

Scissors.

Spatulus.

Spirit lamps or gas burner. Glass, stirring rods. Thermometer, 0 to 200 c. Tripot stand.

Watch glasses. Water bath.

Water distillation still in case Eye drops and Eye lotions are prepared. Weights, metric, 1 mg to 100 mg.

Wire-gauze.

Pill finisher, boxwood. Pill Machine.

Pill boxes. Suppository mould.

Books: -

The United Sates Pharmacopoeia or the British Pharmacopoeia (Current Edition).

National Formulary of Pakistan (Current Edition).

The Drugs Act, 1976 and Rules made thereunder.

The Pharmacy Act, 1967.

The Dangerous Drugs act, 1930.

IV. General Provision: A pharmacy shall be conducted under the continuous personal supervision of a qualified person referred to in sub-rule (1), rule 20 whose name shall be displayed conspicuously in the premises.

The qualified person shall always put on clean white overalls.

The premises and fittings of the pharmacy shall be properly kept and every thing must be in good order and clean.

All records and registers shall be maintained in accordance with the laws in force.

Any containers taken from the poison cupboard shall be replaced therein immediately after use and the cupboard locked. The keys of the poison cupboard shall be kept in the personal custody of the responsible person.

Drugs when supplied shall have labels conforming to the provisions of the laws in force.

Note: The above requirements are subject to modifications or the direction of the licensing authority, if he is of the opinion that having regard to the nature of drugs dispensed, compounded or prepared by the licensee it is necessary to relax the above requirements, or to impose additional requirements in the circumstances of a particular case.