Bangladesh Pharmaceutical Market-

Quality & Regulatory Prospective

A.T.M. MASUD
General Manager, R&D
DBL Pharmaceuticals Ltd
28 March 2019
Hotel Innotel, Banani, Dhaka
 Emerging Asian Tiger
When people talk about the ‘Asian Tigers’ they’re typically referring to Hong Kong,
Singapore, South Korea & Taiwan. The 4 countries experienced rapid growth
between the 1960’s and 1990’s.

But now there is another country that should come to mind: BANGLADESH
The Bangladesh economy has been one of the top performers in Asia over the past
decade, averaging annual growth of more than 6%. Much like Hong Kong, Singapore,
South Korea & Taiwan during the industrialization of their economies. Most of the
growth that Bangladesh has experienced has come from Garment exports, the
second one is Pharmaceutical sector.

 Jonathan Garber, BUSINESS INSIDER (USA based global business magazine).

Time to Roar…

 World Economic Forum, World Bank, Asian Development Bank,

United Nation, WHO, WTO and other world Financial institutions
ranked Bangladesh as emerging country which follows salient
development growth and other Socio-Economic advancements
remarkably. Bangladesh based on an effective methodology
using a good number of sustainable development indicators, the
largest Least Development Country (LDC) in terms of population
and economic size, looks likely to leave the LDC category by the
year 2024. Our Golden Bengal will then put it’s proud footstep
into the club of Developing countries.
Bangladesh covers the Most
Yes so. This slide takes you there
Milestones of
Pharmaceutical Industry
Government Policy
 National Drug Policy 1982
 National Drug Policy 2005
 National Drug Policy 2016
National Drug Policy of 1982
Focusing on the Future

 To provide administrative and legislative support for

ensuring quality of essential drugs
 lowest competitive price
 To eliminate non-essential medicine
 To promote production of local drug and raw materials
 To develop proper drug monitoring and information system
to prevent wasteful misuse
 Drug Policy-2016
Approaching the best
 Allopathic, Ayurvedic, Unani, Herbal, Homeopathic and
Biochemic drugs under one umbrella.
 Upgrade Directorate of Drug Administration (DGDA) to a
National Regulatory Agency (NRA).
 Establish National Control Laboratory (NCL) and its
branches.
 Manufacturers TO follow DGDA GMP Checklist and perform
Internal Audit.
 Initiative to set up an world class API park.
Outcome of Drug Policy

Local Market share

Effect of Drug Policy
Forecasting of Promising
Export
 Key driving force

Updated knowledge Highly skilled human

and brainstorming resource
innovations

State of the art manufacturing facility following

Stringent GMP, GLP and most importantly QbD
in product development
API Park
 To achieve capability to produce
world class quality API’s.
 To increase the contribution of

API sector in national GDP.

 To decrease import dependency

from 97% to 80% by 2032.

 To facilitate employment

of 500,000 people by 2032.

Government Initiative for
API park
 Tax holiday until 2032.
 VAT exemption.
 20% cash incentives on export (at present we
are exporting our API’s to 9 countries only).
 Up to 12 years tenure for Term loan facility.
 Up to 40% export retention.
 Back to back letters of credit facility.
 What is Quality
of a pharmaceutical product?
It delivers the properties described on the label and is not contaminated
- Dr. Woodcock

• Fitness for intended use

• Freedom from defects
• Meeting or exceeding customer expectations
• Customer's definition of quality is the only one
that matters
For a Drug Product, Typically the
Patient Cannot “See” Quality!

The Patient Expects Quality!!

 Quality: A New Paradigm
 Quality must be built in design, quality cannot be tested into
products.
 Better utilization of modern science throughout product lifecycle
 QRM is a key enabler throughout product lifecycle.
 Robust PQS, with appropriate knowledge management, assures
quality throughout product life cycle.
 An integrated approach to development, manufacturing and
quality for both industry and regulators.
ICH Quality Guidelines
 Q1 Stability
 Q2 Analytical Validation
 Q3 Impurities
 Q4 Pharmacopoeias
 Q5 Quality of Biotech Products
 Q6 Specifications
 Q7 Good Manufacturing Practice
 Q8 Pharmaceutical Development
 Q9 Quality Risk Management
 Q10 Pharmaceutical Quality System
 Q11 Development and Manufacture of Drug Substances
 Q12 Lifecycle Management
 Q13 Continuous Manufacturing of Drug Substances and Drug Products
 Q14 Analytical Procedure Development
REACHING THE POTENTIAL: CHALLENGES

 Regulatory driven Quality improvement

 Setting up more state of the art CMO’s.

 Development of Bioequivalence Lab and Clinical Research Facility

 Human Resource Development

 Ensuring Quality of Medicine

 Development in Backward Linkage and World class API park.

Regulatory Prospective
 Intellectual property rights granted by the WTO for the least
developed countries until 2033

 2 Bangladeshi companies obtained FDA accreditation in June

2015. Other companies are ON THE WAY..
Contract Research Organization (CRO)

DGDA has approved 7 CRO’s for Clinical trial

1. Khwaza Yunus Ali Medical College & Hospital.
2. Clinical Research Organization Ltd.
3. International Centre for Diarrhoeal Disease Research,
  Bangladesh (icddr,b)
4. Filaria and General Hospital.
5. Beximco Bioequivalence Center.
6. Projahnmo Research Foundation.
7. Eminence Associates for Social Development.
for your part in my journey