Forensic Pharmacy

Dr. Zirwa Asim

Forensic
• What comes to your mind when you read the
word forensic???
Forensic
• One of the first things that happens when a
person dies on television or in the movies is that
forensics is called.
• This leads to the common misconception that
“forensic” means death.
• While crime scene management and conducting
autopsies for medico legal purposes is certainly
within the broad field of forensics.
Forensic science
Forensic Fraud Death Forensic
toxicology examination investigation photography

Forensic Forensic
Forensic fingerprints
pathology medicine
meteorology

Document Forensic Forensic Forensic

examination psychology geology medicine

Forensic Forensic Record Forensic

psychology nursing evidence serology

Hand
Polygraph Forensic Forensic
writting
examination chemistry pharmacy
analysis
forensic
• The word forensic is derived from Latin term
Forencis, meaning a forum , a place for
interaction or deliberation.
• Jurisprudence means study of fundamental laws
and in case of pharmaceutical jurisprudence, it is
law relating to pharmacy.
Forensic Pharmacy
• Forensic Pharmacy or Pharmaceutical Jurisprudence is
that branch of pharmacy, which deals with various
legislations pertaining to, drugs and pharmaceuticals
and profession of pharmacy.
• This subject encompasses the knowledge of various
Acts, Rules, Statues, Schedules, Sections etc., pertaining
to procurement, manufacture and distribution of
different kinds of dosage forms.
• The knowledge of Forensic Pharmacy is essential to
understand the legal aspects pertaining to practice of
pharmacy.
History of Drug legislation
• During 1920-1930 there were number of reports of harmful
substitutes and adulterants being marketed in place of
genuine drugs and toxic effects of such drugs were published
in Indian press from time to time.
• No control over the manufacturing, sale and distribution of
drugs.
• Several deaths were reported due to spurious drugs. In place
of eye drops, croton oil was used.
• Chalk powder was frequently found to be used for
adulteration of drug formulations.
• There were toxicity reports due to overdose of mercury
compounds.
• In the absence of effective Acts and Rules related
to drugs and pharmaceuticals in the country,
there was a rat race for manufacturing of sub-
standard, spurious and adulterated
formulations.
• DEC Drugs enquiry Committee was constituted
in 1930.
• Drugs and cosmetic act was enacted in 1940.
AN OVERVIEWOF DRUG
LAWS
 Drug Laws
1. The Drugs Act,1976
2. The Rules framed under the Drugs Act , 1976
3. The Pharmacy Act,1967
4. Control of narcotics substances Act 1997
5. The poisons Act, 1919
6. The factories act, 1934
7. Shops and establishments ordinance
 THE DRUGS ACT 1976
An Act to regulate the
import,export,manufacture,storage,distribution and
sale of drugs.

S 1: Short title,extent and

commencement.

S 2: Application of other laws not

barred.

S 3: Definitions.

S 4: Regulations and prohibitions of

S 5: Regulation of manufacture of drugs.

S 6: Regulation of sale of drugs.

S 7: Registration of drugs.

S 8: Pakistan National Formulary.

S 9: Appellate Board

S 9-A: Appeals to the Provincial Appellate

Authority.
 Contd. . .
S 10: Expert committees.
S 11: Provincial Quality Control Board.
S 11-A: Conflict of interest.
S 12: Powers to fix maximum prices of drugs etc.
S 13: Directions to Provincial Governments.
S 14: Federal Drug Laboratories and Institutes etc.
S 15: Provincial Drug Testing Laboratory.
Contd. . .
S 16: Government Analysts.
S 17: Inspectors.
S 18: Powers of Inspectors.
S 19: Procedures for Inspectors.
S 20: Persons bound to disclose place where drugs
are manufactured or kept.
S 21: Disclosure of the name of the manufacturer.
Contd. . .
S 22: Reports of Government Analysts.
S 23: Import , manufacture and sale of drugs.
S 24: Control of advertisement.
S 25: Control of sampling.
S 26: Control of printing of labelling.
S 27: Penalties.
S 28: Penalty for subsequent offence.
Contd. . .
S 29: Forfeiture.
S 30: Cognizance of offences.
S 31: Drug Courts.
S 32: Pleas
S 33: Application of law relating to customs
and powers of officers of customs.
S 34: Offences by companies.
Contd. . .
S 35: Publications of offender’s name.

S 36: Powers to exempt.

S 37: Inspector to be public servants.

S 38: Indemnity.

S 39: Finality of orders etc.

S 40: Publication of result of test or analysis.

Contd. . .
S 41: Cancellation or suspension of licenses.

S 42: Cancellation or suspension of registration

of registered drugs.

S 43: Power of Federal Government to make

rules.

S 44: Power of Provincial Government to make

rules.

S 45: Repeal and savings.

 Rules framed under The Drugs
Act 1976
1. Drugs (Licensing , Registering and Advertising)
Rules,1976.
2. Drugs (Appellate Board) Rules,1976.
3. Drugs (Research) Rules,1978.
4. Drugs (Federal Inspectors , Federal Drug Laboratory
and Federal Government Analysts) Rules,1976.
5. Drugs (Imports and Exports) Rules,1976.
Contd. . .

6. Drugs (Specifications) Rules,1976.

7. Drugs (Labelling and Packing) Rules,1986.
8. Punjab Drug Rules,2007.
 The Punjab Drug Rules,2007
1. Short title and commencement.
2. Definitions.
3. Provincial Quality Control Board.
4. District Board.
5. Procedure for the Board.
6. Qualifications etc. of Inspectors and Government
Analysts.
7. Duties of Inspectors.
Contd. . .
8. Prohibition of disclosure of information.
9. Form of order not to dispose off.
10. Form of Intimation for purpose of taking samples.
11. Duties of Government Analysts.
12. Procedure on receipt of samples from Inspectors.
13. Fee for test and analysis of drugs.
14. Licenses under the rules.
15. Application and fee for licenses.
16. Forms of license to sell drugs.
Contd. . .
17. Sale at more than one place.
18. Duration of licenses.
19. Conditions for issuance of licenses.
20. Conditions of licenses.
21. Cancellation or suspension of licenses.
22. Provincial Appellate Authority.
 SCHEDULE “A”
Form 1: Monthly report from Inspector.
Form 2: Monthly report from Drug Testing Laboratory.
Form 3: Order regarding person not to dispose off stock
in his possession.
Form 4: Intimation of purpose to person from whom
the sample(s) is taken.
Form 5: Receipt for stock of drugs and other material
articles seized.
Contd. . .
Form 6: Memorandum to Government Analyst.
Form 7: Report of test/analysis by Government
Analyst.
Form 8(A): Application for license to sell drugs by way
of Pharmacy.
Form 8(B): Application for license to sell drugs
(excluding the drugs specified in schedule “G”) by way
of medical store.
Contd. . .
Form 8(C): Application for license to sell drugs by way
of Distribution.
Form 9: License to sell drugs in Pharmacy.
Form 10: License to sell drugs in Medical Store.
Form 11: License to sell drugs by way of Distribution.
 SCHEDULE “B”
NARCOTICS,PSYCHOTROPIC,ANTI-
DEPRESSENTS and other controlled drugs.

SCHEDULE “C”
Fee for test analysis.
 SCHEDULE “D”
Drugs to be sold by a retailer strictly on the prescription
of registered medical practitioner.

SCHEDULE “E”
Drugs when dispensed to be labelled with
the word “poison”.
 SCHEDULE “F”
List of minimum requirement for a Pharmacy.

SCHEDULE “G”
Drugs not to be sold/stored by license on Form 10
(medical store).
 SCHEDULE “H”
Good Storage and Distribution Practices in line with the
WHO guidelines.
 The Pharmacy Act ,1967
1. Short title, extent and commencement
2. Definitions
3. Establishment of Pharmacy Councils
4. Composition of Central Council
5. Composition of the Provincial Council
6. Disqualification for membership
7. Publication of names
8. Term of office
9. Filling of casual vacancy
10.Vacancy, etc., not to invalidate the proceedings of a
Council
11. Election of Vice-President
12. Committees of a Council
13. Meetings of a Council
14. Annual report
15.Appointment of Secretary, officers and staff of the
Council
16. Finances
17. Functions of the Central Council
18. Approval of examinations
19. Approval of courses of study
20. Furnishing of information
21. Inspectors
22. Withdrawal of approval
23. Functions of a Provincial Council
24. Preparation and maintenance of Registers
25.Qualifications for registration as a pharmacist or as an
apprentice in pharmacy
26. Procedure for registration
27. Certificate of registration
28. Revocation of certificate
29. Examination for registration as pharmacists
30. Qualifications for admission to an examination
31. Prohibition of practice without registration
32. Cognizance of offences, etc
33. Indemnity
34. Power to make bye- laws