The challenge with any of the emerging markets such as the BRIC (i.e., Brazil, Russia, India, and China) nations and the newly
named Next 11 (i.e., 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 FDA and the EMA. Another point to consider is the varying role of the government in establishing
these operations. Nigeria, for example, has a desperate shortage of intravenous bag-manufacturing capacity; in fact, much
of Africa falls into this situation. However, anyone contemplating establishing an aseptic operation to produce intravenous
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, the new GMP 10 guidance uses a public safety
risk framework, which fundamentally means anyone attempting to establish an aseptic operation can expect Chinese State Food
and Drug Administration involvement in their plant (1).
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 international requirements. 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 (2). 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.
What China will bring to the marketplace in the long run, however, remains an open question. The initial lure of low-cost
manufacturing and packaging is still attractive to many western business strategies. While investment in Chinese manufacturing
remains strong, the most successful western organizations have found that establishing their own operations in China, complete
with a skilled leadership and management team versed in western compliance understanding, may be a better recipe for success
than tapping existing local manufacturing capability. In terms of understanding, China is rapidly climbing the compliance
ladder, but the big question is can China maintain its cost-competitive environment while building a western quality-management
In the background of all this change is the fact that the Chinese government still has a majority interest in most large corporations
in China, which means that political considerations are always present in every conversation and negotiation. How the government
will continue to balance free market business and government oversight is a big unknown. As the country firms up its intellectual
property protection laws and moves to a rule of law basis for legal protection, the separation of government and private-sector
interests will be tested if parity can ever truly be achieved in business. For now, there is never a level playing field when
conducting negotiations in China.
Five years ago, I would have said that it would be unlikely that China could develop a quality mindset that is compatible
with that of the western markets. However, in China things move quickly. I do believe there is still a fundamental gap with
the basic quality mindset of the west, but the business drivers for closing this gap are emerging quickly. The most significant
driver for change has been the issuance of the GMP 10 guidance, which has quickly seized the Chinese market's attention. The
second driver is the rapid growth of the Chinese national market. Increasingly, Chinese developers and manufacturers are striving
for FDA compliance, not because of their desire to enter the US market, but because they would like to command higher prices
and market position in their home market. In the end, this motivation may turn out to be the biggest driver in catalyzing
change in China's approach to quality.
Bikash Chatterjee is president and chief technology officer at Pharmatech Associates, USA.
1. SFDA, Good Manufacturing Practices for Drugs (October, 2010).
2. Pharmaceutical and Biotech Industry Global Report — 2011 (IMAP Healthcare Report, 2011).