In an effort to strengthen exports and address the widening trade deficit with China, the government of India has embarked upon several initiatives to identify specific product lines and also has been actively taking up issues relating to tariff and non-tariff barriers in bilateral meetings and institutional dialogues.
According to Union Commerce and Industry Minister, Nirmala Sitharaman, India has consistently sought greater access to China market , especially in pharmaceuticals.
Currently, China and India are two strong players in the pharmaceuticals market globally. The sluggish regulated markets of the US and Europe have made the two large economies in Asia to come together to focus on a long term strategic perspective.
In 2010, Government of India and Republic of China had joined hands to strengthen the business environment between the two countries under the Strategic Economic Dialogue (SED). Under the SED umbrella, Indian government had called for greater market access for pharmaceuticals.
In an age of open economy, collaboration, integration and co-operation are the cornerstones. This is where SED, which has four working groups on infrastructure, energy, environment and high tech sectors that includes the pharmaceutical industry, could converge for collaborative growth.
Industry observers state that Indian pharma cannot ignore the market of China. While India is sound in chemistry, China has its prowess in fermentation. But the biggest advantage for India is the availability of its qualified scientific English speaking pool which allows easy submission of documentation, along with a dependable quality standard in place because of stringent regulatory clearances.
China falls short here despite its impressive and large production volume capability. The dragon land has a long way to go in terms of regulations although its State Foods and Drugs Administration (SFDA) has put in place stringent rules and norms to be adhered to. It will take a minimum seven years for China to catch up with India in document submission and in following regulations.
The two countries have the highest global population offering a market for all types of pharmaceuticals covering active pharmaceutical ingredients (APIs), excipients and intermediates, finished dosage forms including generics. There is ample scope for India and China to tap the business but it would be better to collaborate and move ahead, noted experts.
Chinese chemical synthesis is focused towards low-end generic API products in comparison with Indian companies who have rapidly improving skill basis for new higher end generic products as well as drug discovery.
Chinese API manufacturers are less organized than their Indian API industry for supplying documentation to the client for drug master files (DMFs), current good manufacturing practices (cGMP) compliance and above all almost complete lack of knowledge of regulating affairs in the markets like the US, European Union and Japan. Chinese API manufacturers are less market- oriented in terms of presentation of their product portfolios, as well as in terms of organization of the sales network on a worldwide scale.
According to Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA), from a global perspective, pharma majors are increasingly eyeing opportunities to outsource research and manufacture from India and China. The new stringent regulations would enable global companies to ensure the high quality standards. Now with the US FDA coming down heavily on Indian pharma companies and issuing 483 warnings, there are similar alerts issued to units in China. Even the European regulatory authority EDQM has suspended certificate of suitability COS of several drug manufacturers in India and China. But with Indian pharmaceuticals known to be 14th in terms of value and fourth in terms in volume, it has proved its expertise in areas of CRAMS.