1) The document discusses the cultural relationship between the quality of drugs and the prevailing regulatory environment in Pakistan. It notes that while over 500 pharmaceutical manufacturing facilities are located in Pakistan, the quality of drugs has yet to meet modern world standards. 2) It emphasizes that to compete globally, Pakistani drug manufacturers must apply harmonized quality standards such as those outlined in ICH guidelines and obtain membership in organizations like PIC/S. Demonstrating consistent quality and safety of generic drugs through rigorous testing and inspections is important. 3) Developing a "culture of quality" through collaborative efforts between industry, regulators and government, with transparent communication, is key to improving drug standards and reducing the gap with international levels of quality

1. Pakistan Pharma
Summit 2016
Hotel Pearl Continental, Karachi
O b a i d A l i
R. Ph., M. Phil, Ph. D.
Cultural Relationship between Quality of
Drugs & Prevailing Regulatory
Environment
DISCLAIMER
It is the current judgment and 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

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Cultural Relationship between
Quality of Drugs & Prevailing Regulatory Environment
Advancement in sciences and technology in
the global pharmaceutical industry continues to
impact millions of people by providing them,
often for the first time, with medication
necessary to prevent early death, serious illness
or irreversible disabilities. Over 500 industries
with multiple dosage form pharmaceutical
manufacturing facilities located in Pakistan
(irrespective of global, regional or national players) have yet to demonstrate quality up to the standards of
modern world. On the other hand, Government of Pakistan has not engaged so far in any efforts of global
harmonization related to common regulatory operations committed to guarantee the quality, safety and
efficacy of drugs. Unlikely with emerging countries, none of the product is in queue of microscopic
examination of the developed world, however, encouraging signals to compete the world are visible and
appearing from few of the industries that have a long way to go. Clear understanding of potential safety,
efficacy, quality and integrity issues with the local manufacturing of drugs is the key to formulate
progressive framework for success. It is high time to understand potential threats associated with the
quality of drugs and opportunities of the global business in the spirit of science, trust and norms of
civilization. It is correct to emphasize that gravity and passing time does not care of anyone.
Pakistani pharmaceutical industry is manufacturing generic drugs and they are by and large not asked to
have data of animal (pre-
clinical) and human
(clinical) trials to see its safety
and effectiveness.
However, generic drugs
are expected to deliver the
same amount of drug at the
same pattern of time as
established by the innovator.
To prove the formulation as
a trusted generic, a sufficient amount of data supporting its comparability to innovator drugs with regard
Application of harmonized norms such as
Quality Documents & Common Technical
Document (CTD) of International
Conference on Harmonization (ICH) in its
true spirit are mandatory to enter the trade
of modern world
Sincere efforts of DRAP to obtain membership of
Pharmaceutical Inspectorate Cooperation Scheme
(PIC/S), participation in both regional and global
harmonization particularly, International Coalition of
Medicines Regulatory Authorities (ICMRA) &
International Generic Drug Regulators Pilot (IGDRP)
is indispensible to walk together with the world

3. 3 /3 P a g e O b a i d A l i - 3 r d M a y 2 0 1 6
to its dosage form, strength, route of administration, quality, performance characteristics and intended use
is required to be presented before the Regulatory Authority for review and assessment. Based upon
independent and multiple assessment/reviews reports followed by summary of approvals, the product
comes into bright as low cost alternative and substitute (in most of the cases) of the innovator drug. The
role of generic drugs in healthcare system is a great gift from generic players that played, is playing and
will continue to play a marvelous role to save the lives of poor mankind.
Chemistry, Manufacturing and Controls (CMC) of Drug Substance and Drug Product are inevitable to
develop a reliable drug formulation. Consistency among each unit within batch and batch after batch,
control of microbial or non-viable contamination, control of
drug cross-contamination and potential of drug or label or batch
mix up at any stage of manufacturing process of commercial
batches are evaluated through inspection of Quality System and
its integrity. Post-marketing surveillance on quality and
vigilance on safety through structured studies and initiatives
demonstrate commitment of the manufacturer to the patient and
Regulatory Agency. Before discussing the export and trade, it
will not be unjustified to invite attention on inherent moral
obligations of manufacturers associated with the safety of consumer and quality of drugs. Sincere
mapping of manufacturing facilities and practice to examine the strength and sustainability of control
strategies in place is required to unfold the real and clear picture and have an insight of the iceberg. To
start journey from doable to desirable efforts for quality of drugs, their moral obligations and real
challenges need to be mapped with all sincerity. We must be very clear that changing world will not wait
for our belief or initiation of action but will leave us far behind otherwise. To reduce the expanding gulf
by evolving standards of science, a progressive and smart strategy along collaborative working among
Industry, Regulatory and Government with controlled and transparent communication is the key to take
off.
Note: All comments and questions are welcome at oarohama@gmal.com.
Sustainable quality of
drugs with high integrity of
data need to be
demonstrated through
Culture of Quality (CoQ)
by the manufacturer