The Challenges Of The Emerging Markets - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

The Challenges Of The Emerging Markets


Pharmaceutical Technology Europe
Volume 23, Issue 8


Bikash Chatterjee
The challenge with any of the emerging markets such as the BRIC (Brazil, Russia, India and China) nations and the newly named Next 11 (Mexico, Nigeria, Egypt, Turkey, Iran, Pakistan, Bangladesh, Indonesia, Vietnam, South Korea and the Philippines) is in adjusting to the western regulatory concepts of quality and compliance. Most country-specific regulatory guidance in the emerging markets is more focused on basic quality principles, such as sanitation and cleanliness, than the sophisticated framework of the FDA and EMA. Another point to consider is the varying role of the government in establishing these operations. Nigeria, for example, has a desperate shortage of IV bag manufacturing capacity; in fact, much of Africa falls into this situation. However, anyone contemplating establishing an aseptic operation to produce IV bags must contend with oversight from the Nigerian Senate and use local subcontractors and suppliers, which complicates compliance oversight if you are striving to meet FDA aseptic standards. Meanwhile, in China, new GMP 10 guidance uses a public safety risk framework, which fundamentally means anyone attempting to establish an aseptic operation can expect Chinese SFDA involvement in their plant.


C.O.T/a.collectionRF/Getty Images
The challenge in building a facility for both emerging and global markets is navigating the country-specific compliance requirements for facility design and process while satisfying the international. This may seem trivial at first glance, but there are unique elements to each guidance and the impact on facility design and cost can be significant. For example, to manufacture a cytotoxic product on one line in an isolator, the EU will only require a Grade D environment around that isolator, while the US would expect a Grade C environment. Couple this with the SFDA's desire to have two gowning airlocks for each Grade change and the facility design becomes complex very quickly.

The rise of China

China is an important country and it is undeniable that its role in the global pharmaceutical market is evolving. IMAP analysts project the Chinese healthcare market will soon become the third largest in the world, with an estimated market value of over $40 billion (1). Today, China produces nearly 70% of the world's generic APIs and, despite some very high profile missteps, it continues to increase its market presence.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
26%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
10%
All of the above.
43%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology Europe,
Click here