cultural relationship between quality of drugs and prevailing regulatory environment

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 linesPPMA Summit 2016

03rd MayKarachi

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

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

Quality

SupportRegulations

EXPORT

With few exceptions

PharmaIndustry

Govt. Facilitation

Regulatory Authority

EXPORT

With few exceptions

USA

EU

Japan

Canada

WHO

Australia

Leading the pharmaceutical world through ICH

Common Guidance Formats Language

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

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

Drug Quality

From Moral Obligation toReal Challenges ?

A large number of manufacturing facilitieswith very few exceptions

Honest Question

Honest Question

Does our drug quality competes with minimum

global standards ?

Sincere Concern

Sincere Concern

What is the quality of drugs consumed by our citizens ?

Lets ask from our

Heart

Why notQuality Drugs for us

Who stopped us ?

Lets ask from our

Heart

See back mirror to move forward

See back mirror to move forward

How & who made DRAP incompetent?

If DRAP turns competent

What would happen If DRAP turns competent

Time to take decision for your loved one

Life cannot be weighed with costWe must not allow to play with life, if does

not have minimum standards of quality

Learn to live with

difference of opinion

Remove Ego, Manage Knowledge,

Manage Value, Respect Science, Protect Honesty

Thank you of invitation & listening

oarohama@gmail.com