PMA Discussion ... (Pakistan Medical Association, Karachi)

1. Drug Quality ?
Obaid Ali
BSc, BPharm, MPhil, PhD
Pakistan Medical Association, Karachi May 14th 2018

3. Back & side mirror reality
Dashboard Story
Windscreen Reality

4. Drug Quality cannot be
seen by naked eye or
tested by laboratory
It has to be built in

5. Roohi B. Obaid, DDC, DRAP, Jan 2015
Typically Consumer Can not
see Quality

6. The drug which is
tested is not used &
The drug which is
used, is not tested

7. Innovator drugs Generic drugs

9. Drug developed Clinical data Marketed

10. Drug developed Clinical data Marketed
Generic developed Clinical relevance Marketed

11. Generic
Development
Bio-studies
Plant Inspection
CMC
Label, Claim & Use

12. Generic
Development
CMC
Drug Substance
Drug Product
Quality Attributes
Shelf life

13. Generic
Development
Bio-studies
BA / BE Studies
Clinical end point
Dissolution studies

14. Generic
Development
Plant Inspection
Consistency Mix up Contamination Traceability

15. Generic
Development
Label, Claim & Use
Same
Look alike
Sound alike
Off label use promotion
Etc.

16. We know
Positioning
of Pakistan’s Regulatory Authority
Pakistan’s pharmaceutical products

17. Some Relative Facts
>135 manufacturing facilities approved for GMP by US-FDA
Approx. 8 billion USD export/imagine contribution in
healthcare system
Manufacturing from new to generic drug

18. Some Relative Facts
US-FDA has multiple offices
Expending billions of USD
More than 100 inspectors for inspections

19. Some Relative Facts

20. Safe, efficacious & have correct
identity
Deliver the same performance as
claimed
Perform consistently over shelf
life
Made in a manner that ensure
quality
Will be available when needed
Patient and
Doctor
assume that
Drugs are

21. Thank
You