Syed Muhammad Muneeb AnjumLecturer, IPS, UVAS

What to cover……Legal DocumentationRegulation & Record KeepingPharmacy Layout & Design

LegislationSubcontinent

Drugs act 1940

Pharmacy Act 1967An act to establish Pharmacy Councils to

regulate the practice of Pharmacy

Drugs Act 1976

Punjab Drug Rules19882007

Overview of PDR 2007Chapter 2 (Rules 3-13)

Provincial Quality Control BoardDistrict board

Constitution and Procedure for boards

Government analyst Inspector

Requirements for the appointment of provincial drug inspectors and analysts

Duties of inspectors Duties & Procedure for Analyst

Overview of PDR 2007…PharmacyMedical Store

Chapter 3 (Rules 14-22)Sale of drugs

14- Licenses under the rules Licensing Authority

Secretary Health or his appointed Govt. officer15- Application and fee for license

New License– Form 8 (A) 3000 Pharmacy 2000 MS

Renewal of License – Form 8 (B) 2000 Pharmacy 1000 MS Change of qualified person Half Fee

Sale of drugs Head of Account No.

1252-Health-Other Receipt

16- Forms of licenses to sell drugs Pharmacy

Form 9 Medical Store

Form 1017- Sale at more than one place

One License One place18- Duration of Licenses

1- Expiry 31st December of every year Exception suspended

2- 60 days Lag time Cancelled after wards

Sale of drugs 3- 30 Days Same license remains enforced until

cancelled 4- Receipt (Compulsory) 5- 45 days Renewal time 6- Record Reasons for Non issue 7- Application Refusal 8- No Renewal without inspection report

19- Conditions for issuance of licenses 19 (1a)

Facility for storage of drugs Protection from direct sunlight, dust or dirt Refrigeration facility

19 (1b) Clean, hygienic and in tidy premises

Sale of drugs 19 (1c)

Pharmacy compounding fulfillment of the requirements contained in the Schedule F

19 (1d) Pharmacy

Covered > 140 square feet Minimum breadth of 8 feet in the front Height of 8 feet

Medical store (MS), Covered > 96 square feet Minimum breadth of 8 feet Height of 8 feet

19-(1e) Imprisonment > one year or more Fine > Thirty thousand rupees or more

under section 27(1) of the Act

Sale of drugs 19 (1f)

A person registered under section 24(1)(a) of the Pharmacy Act 1967 (XI of 1967) has agreed to personally supervise the sale of drugs for license in Form 9 (pharmacy)

A person who is registered under section 24(1)(a) & (b) of the said Act has agreed to supervise sale of drugs for license in Form 10 (medical store).

2- No license without inspection report of The Secretary of the Provincial Board or the Secretary of

the concerned District Board.20- Conditions of licenses

1- General Conditions and given in license to be followed

20 (1a) Pharmacy Display the word “Pharmacy” outside wall

of the pharmacy “White” writing on a “Green” coloured signboard Min. length of 5 feet and width of 2.5 feet

Sale of drugs Medical store (MS) Display the words “Medical

Store” White writing on a blue colored signboard Same minimum dimensions as required for a

pharmacy 20 (1b)

Person Registered under 24(1)(a) of the Pharmacy Act 1967 (XI of 1967) shall personally supervise the sale of drugs under license in Form 9 (pharmacy)

Person Registered under 24(1) of the said Act shall personally supervise sale of drugs under license in Form 10 (medical store)

20 (1c) Records, the bills or the counterfoils Min. three

years from the date of the sale

Sale of drugs

FormsSCHEDULE A

FORM 1 Monthly report from inspector

FORM 2 Drugs testing laboratory progress report

FORM 3 Order under section 18(1) of the Drugs Act,

1976 regarding person not to dispose of stock in his possession

FORM 4 Intimation of purpose to person from whom

the sample (s) is taken

FormsFORM 5

Receipt for stock of drug and other material articles seized under section 18(1) of the Drugs Act, 1976

FORM 6 Memorandum to government analyst

FORM 7 Report of Test/Analysis by Government Analyst,

PunjabFORM 8 (A)

Application for the license to sell, store and exhibit for sale & distribute drugs by way of pharmacy

FORM 8 (B) Application for the license to sell, store, exhibit

for sale & to distribute drugs excluding the drugs specified in Schedule “G” by way of Medical Store

FormsFORM (9)

License to sell drugs in a PharmacyFORM (10)

License to sell drugs in “Medical Store”

SCHEDULESSCHEDULE ‘B’

Narcotics psychotropic, anti depressant and other controlled drugs

SCHEDULE ‘C’Fee for testing

SCHEDULE ‘D’To be sold by a retailer strictly on the

prescription of registered medical practitioner Antibiotics Antihistamines

SCHEDULE ‘E’Poisonous substances

SCHEDULE ‘F’List of minimum requirements for a

pharmacySCHEDULE G

Drugs not to be sold/stored by licensee in form no.10