The ambitious Strategy Plan of the Ministry of Commerce to double pharmaceutical exports from US$ 10.4 billion in 2009-10 to US$ 25 billion by 2013-14 and the ‘Pharma Brand India’ promotion action plan spanning over a three-year period to give an impetus to generic exports will also help boost the prospects of the active pharmaceutical ingredients (APIs) sector.

The key objective of the Strategy Plan is to utilize the international opportunities opening up in the area of formulations, APIs, herbals nutraceuticals and medical devices.

Over 60 per cent of India's bulk drug production is exported. India's pharmaceutical exports are to the tune of US$ 10.32 billion in 2010-11 of which formulations contribute nearly 55 per cent and the rest 45 per cent comes from bulk drugs.

“India is increasingly becoming an important source of generics in view of its rich vendor base. It is not only an API and formulation manufacturing base, but also as an emerging hub for contract research, biotechnology, clinical trials and clinical data management. In 2010-11, the country registered a CAGR of 15.1 per cent in exports of pharmaceuticals and fine chemicals. This has led the GOI to extend its assistance in help to garner growth from the global arena,” Dr PV Appaji, executive director, Pharmexcil India, had told Pharmabiz recently.

Going by India’s strength as the highest formulation producer in the world, 14th in volume for pharmaceuticals in general and accounting for third in value after US and Europe, the GOI has been keen to capitalize and  strengthen the sector’s position.

The Indian pharma industry has gained significant  global presence in the last few years Its remarkable growth can be attributed  to its ability to rapidly access and adopt new technologies and also  to its success in evolving an effective mechanism to strengthen research and development.

The robust Indian pharma industry today produces a range of formulations, has the expertise for  APIs and sees significant opportunities for value-creation. Hence, the theme of the recently concluded 63rd edition of IPC was , ‘Pharma Vision 2020: India: The Pharma Power house’, had aptly captured the present stature of the Indian pharma industry.

India ranks third in terms of manufacturing pharma products by volume and 14th in value terms globally. The Indian industry produces around 20  to 24 per cent of the global generic drugs.

The significant changes in the global pharma market offer immense opportunities  for Indian pharma industry. Patents around $13 billion in the US revenue of blockbuster drugs expired in 2007 and patents worth $ 60 billion will expire by 2012. As a result, the newly available market will be filled by generics worth $73 billion.

India is capable of capturing this opportunity and can become a global base for outsourcing of pharmaceuticals since it has  advantages over other countries of the world.

The estimated current turnover of the Indian pharmaceutical industry is Rs. 84,000 crore or US$ 21 billion with an annual growth rate of 13 per cent.

The country is a leading global provider already with an export turnover of over Rs. 40,000 crore or US$ 10 billion to 200 countries. There is a strong manufacturing infrastructure with approximately 161 USFDA, 90 MHRA and 1,000 WHO GMP approved world-class manufacturing facilities in India.

With a stable economy and 10 to 13 per cent growth rate of the industry compared to four to five per cent in the developed countries, India can become a pharma power house and can look forward to be a global destination for manufacturing, R&D and clinical studies of generic formulations as well as new molecules pharmaceuticals, according to  experts.

Though the government has  recognized the remarkable growth of this industry and are taking certain initiatives to support the modernization of the industry, regulatory mechanism, training and education, a lot more needs to be done to encourage the domestic industry in terms of making it competitive compared to Chinese API industry, they add.

The regulatory standards have to be raised on par with the developed countries and all possible assistance has to be given to small-scale industry to encourage compliance with the Good Manufacturing Practices. Although some of the larger companies have taken some  steps towards drug innovation, the industry as a whole has been following the business model of using their expertise in reverse-engineering new processes for manufacturing drugs at low costs until recently. The government needs to support the R&D initiative in a big way for encouraging development of new molecules and innovative delivery systems

At the same time international pharma majors have now increased their expectations from emerging markets like India to adhere to a highly regulated environment with little flexibility.

Regulators globally have now developed a harmonized Pharmaceutical Quality System (PQS) applicable across the life cycle of the product emphasizing an integrated approach to the Quality Risk Management.

US FDA, European and Japanese regulators are focusing on a science-based approach in pharmaceutical development, complying to ICH Q8, Q9, Q10, Q11 (draft) and latest US FDA guidelines on ‘Process validation - life cycle approach’.

This has led Indian pharma companies from Aurobindo Pharma to Cipla, Dr Reddy’s and Ranbaxy along with small and medium scale enterprises engaged in exports to become more cautious about remaining stringent when it comes to quality norms in research and production.

As global majors view India not just for import of APIs and formulations, but as a prime hub for research, formulation development, clinical trials and contract manufacture, drug companies are now working in a highly competitive environment and the regulatory expectations are an additional stress in meeting timelines. However Indian pharma is fast gearing up to get its act to meet the emerging scenario.