Public Health Law Session of Health Policy & Management (MSc Students) at Aga Khan University & Hospital, Karachi

1. Public Health Law Session
Aga Khan University & Hospital
PHARMACEUTICAL INDUSTRY
Legislation & Regulation
Essential Medicines & Technology
Obaid Ali, R.Ph., M.Phil., Ph.D.
Civil Service Officer at Drug Regulatory Authority of Pakistan

2. Because
Drugs are public good and not simply just another commodity:
first for their high social value, and then because consumers and
prescribers are unable to assess their quality, safety and efficacy.
Quality cannot be observed by every one and/or by naked eye.
Quality cannot be tested in a laboratory but has to be built in to
the product

4. NewTools
Approaches
Standards
E
Q
P
S
R
E
G
U
L
A
T
O
R
Y
S
C
I
E
N
C
E

5. Science driven by scientific
methods
Difficult to capture art of
pharmacy or medicine
Uncertainty and Complexity
in real world practices and
realities
Hard
Boundaries
Flexibility
Judgment
space

6. Space and Boundary for today’s discussion

7. Outline of key legislations regarding pharmaceuticals in Pakistan
Drugs
Act
1976
DRAP
Act
2012

8. Regulatory bodies & processes regarding Pharmaceuticals,
Technologies and Devices
Regulatory Bodies/
Regulatory Processes
• Federal Government
through Drug
Regulatory Authority of
Pakistan
• Provincial Government
through Health
Department of their
province
Federal Government
• License to manufacture
drug
• Registration/Market
Authorization of Drug
• Pricing of Drugs
• Advertisement of Drugs
• Import & Export of
Drugs
Provincial Government
• Sale of drugs
• Storage, distribution
and transportation of
drugs

9. Pharmaceutical regulation-Post18th Amendment
Resolution of provinces to authorize formation of centralized DRAP
Promulgation of DRAPAct 2012
Adoption of Drugs Act, 1976 under DRAP Act, 2012
Re-notification of all rules framed under Drugs Act, 1976
Additional Rules e.g. medical devices, Natural Health Products
Constitutional threats-provinces can withdraw their authorization any time

10. Drug Act
1976
Drug Regulatory
Authority Act 2012
Rules &
Regulations
Punjab
KPKPunjab
Balochi
stan

11. Manufacturing Registering Licensing Advertising Pricing Sale
Drugs Biologics

12. Laws and regulations – national and international regarding price of
pharmaceuticals with special emphasis of essential medicines
Prices are controlled in Pakistan
under law

13. WTO rules and debates about access to critical medicines in developing countries
at affordable price – example HIV/AIDS medicines
Data
protection
Patent
Intellectual
property
rights
Data
exclusivity
Compulsory
licensing

14. Patent
period
Patent
expired

15. Trust on Safety, Efficacy & Quality
is not simple but so complex

16. Look Back Ground Stage Move forward
1 2 3

17. Look Back Ground Stage Move forward
1 2 3

19. Thalidomide
Tragedy
Diethylene
Glycol
Contamination
Heparin
Catastrophe
Pyrimetamine Mixup
Medication
Errors
Cutter Incidence

20. Kellse

21. Look Back Ground Stage Move forward
1 2 3

22. Pre Market
Manufacturing &
Supply
Post Market
Translational
Science

23. Pre Market
Clinical
Trial
Safety
Quality
Efficacy
Label
Claim

24. Pre Market
Safety
Brain
Heart
Lungs
Liver
Kidney
Blood

25. Smart Strategy
No new drug will be
approved unless it has
passed the scrutiny
and experience of
developed world
Pre Market

26. Pre Market
Safety
USA
Europe
CanadaJapan
Australia

27. Pre Market
Efficacy
From where the challenge
begin specially with
generics

28. Pre Market

29. Same Label Claim
Chemistry, Manufacturing & Controls
Bio-Studies
GMP Compliance

31. Pre Market
Bioavailability is the only
surrogate marker of clinical
studies

32. Pre Market
Dissolution is
the mathmetical
marker of
bioavailability
studies

33. 1 2
3 4
Solubility
Permeability

34. Highly Soluble
Highly Permeable
Highly Soluble
Less Permeable
Less Soluble
Highly Permeable
Less Soluble
Less Permeable

35. Pre Market
Quality
Identity
PurityStrength

36. Quality Safety Efficacy Identity Purity Strength

37. Pre Market
Quality
Contamination
Mix-up
Consistency
Label
claim

38. Manufacturing & Supply

39. Lab Scale
Pilot Scale
Scale up
Commercial scale

40. Consistency Contamination
Mix-up

41. Post Market
Surveillance
& Vigilance
Quality
Risk &
Alerts
Safety
Medication
errors
Signal
detection

42. Look Back Ground Stage Move forward
1 2 3

43. Data integrity, risk
mitigation and
management
Reasonable balance
between safety and
innovation
Knowledge sharing
and mutual
recognitions
Smart, progressive
model to reduce
regulatory burden
Fast access to drugs
for the patient
Drug shortage,
Culture of quality
and Cost of quality
Off-shore working
and contract
services
Move Forward

44. Regulatory world is
touching sky and
getting so complex
Requires interpretation
and somehow leniency
to promote evolution of
science such as off-label
use by physicians
Learn
De-learn
Re-learn

45. DISCLAIMER
Not the view of DRAP
Current judgment
No obligation on DRAP
Regulatory experience
It has nothing to do with
any specific commercial
product
It is just a knowledge
sharing exercise nothing
more than that

46. Thank You
Questions are Welcome
oarohama@gmail.com