This presentation discusses the cultural relationship between drug quality and prevailing regulatory environments. It notes that drug quality has evolved from a moral obligation to real challenges, and asks whether the quality of drugs consumed by Pakistani citizens meets minimum global standards. The presentation expresses sincere concern over the quality of drugs used by citizens and asks why quality drugs are not available for Pakistanis. It questions how and who made the Drug Regulatory Authority of Pakistan incompetent, and suggests that if DRAP became competent, drug quality would improve. The presentation concludes by emphasizing the need to make decisions to protect one's loved ones and not allow lives to be put at risk by drugs that do not meet minimum quality standards.

1. Cultural Relationship between Quality of Drugs &
Prevailing Regulatory Environment
Obaid Ali, R. Ph., M. Phil., Ph. D.
Deputy Director at Drug Regulatory Authority of Pakistan
05 min presentation of 10 lines
PPMA
Summit 2016
03rd May
Karachi

2. Disclaimer
A current judgment & personal view
as a regulator based on experience
and knowledge received from US-
FDA, Health Canada, WHO etc. It
may not be considered as view and
obligation on DRAP

3. Evolution does not care whether you believe in it or not,
no more than gravity does

4. Quality
SupportRegulations
E
X
P
O
R
T
With few
exceptions

5. Pharma
Industry
Govt.
Facilitation
Regulatory
Authority
E
X
P
O
R
T
With few
exceptions

6. USA
EU
Japan
Canada
WHO
Australia
Leading the pharmaceutical
world through ICH

7. Common Guidance Formats Language

8. Common Guidance Formats Language
Lets thank and respect the one and only
Pakistani whose 45+ year worthy contribution
is unmatched so far on the global radar

9. Common Guidance Formats Language
Lets thank and respect the one and only
Pakistani whose 45+ year worthy contribution
is unmatched so far on the global radar

10. Drug
Quality
From Moral Obligation to
Real Challenges ?

11. A large number of manufacturing facilities
with very few exceptions

12. Honest
Question

13. Honest
Question
Does our drug quality
competes with minimum
global standards ?

14. Sincere Concern

15. Sincere Concern
What is the quality of drugs consumed by
our citizens ?

16. Lets ask
from our
Heart

17. Why not
Quality Drugs for us
Who stopped us ?
Lets ask
from our
Heart

18. See back mirror to move forward

19. See back mirror to move forward
How & who made DRAP
incompetent?

20. If DRAP turns competent

21. What would
happen If DRAP turns competent

22. Time to take decision for your loved one
Life cannot be weighed with cost
We must not allow to play with life, if does
not have minimum standards of quality

23. Learn to
live with
difference
of opinion
Remove Ego,
Manage Knowledge,
Manage Value,
Respect Science,
Protect Honesty

24. Thank you of
invitation & listening
oarohama@gmail.com