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.
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.