Even as a large number of challenges including the increasing competition in the global generic market is posing a challenge to the generic pharma companies, strategic movements could bring success to the Indian companies in this growing lucrative market, according to the experts in the global consultancy firm KPMG.

Understanding the key characteristics of regulated markets, complexities in intellectual property (IP) and regulations and building up a sustainable, competent entry, growth strategies for the generic market are the way for the Indian companies to win the global market, said Sanjay Singh, associate director, KPMG. He was delivering the views of the firm in a half-day seminar on 'Bringing Medicines to Global Markets - Opportunities and Challenges' organised by KPMG in association with Indian Drug Manufacturers' Association (IDMA).

The opportunities for generic players in US and European markets are huge, as the annual sales of drugs going off-patent over next five years in US and Europe is almost US$ 80 billion and US$ 20 billion, respectively. With the growth of generics business estimated to grow around 10 to 12 per cent in the coming years, the Indian companies has to identify the opportunities and challenges in this market, he added.

"For instance, a recent comparative study on the US and Indian generic market shows that after six months of product launch, the prices of the generic product in US has gone higher while the price was not changed in India," said Singh.

The changing dynamics between generic companies and innovators in US, the negative impact of continued implementation of cost cutting measures in the fast growing generic market in United Kingdom, the commodity generics scenario, which has been adapted by Germany recently, has their influence in the generics market.

The ineffective state incentives promoting generics use, poor awareness of and trust in generics and little difference in branded and generics drug prices in Italy and Spain even as generics use within the 'Repertoire des Medicaments Generiques' is high with a volume share of 70 per cent in France. The poor generic availability and awareness, and the government reforms to promote generics use are the key issues in Japan while regulations getting stringent and gradual phase out of similars has tend the industry in Brazil to move towards generics. These factors are to be taken into account by the companies which are planning active business in these countries.

However, large generic companies like Teva, Mylan, Apoth-econ and Ivax pose a challenge to the Indian small and medium level companies in their operations in the generic markets. The Indian companies should look into the opportunity of value added generics to overcome these hurdles, opined Singh.

Despite the growing challenges, which appear more and more from unexpected quarters, like the TRIPS Plus measures of some parts of the world and the insinuations implying that these generics from India as counterfeits, the opportunities are wast for the Indian companies in this segment, said N R Munjal, president, IDMA in the opening function of the seminar.

Willaim Sarraille, partner, Sidley Austin LLP detailed about the important issues to be focused by the Indian companies in pharmaceutical price reporting in US. Abhiroop Gandhi, director of global compliance, Actelion Pharmaceuticals elaborated the need and methods to prepare a global compliance programme for the pharma industry in the country.

A panel discussion with the KPMG experts, V V Parasuran, vice-president, Corporate Governance, Dr Reddy's Lab and Adheesh Nargolkar, senior associate with the patent consulting firm AZB & Partners discussed the need of compliance of global regulatory norms by the Indian pharma companies to win the world generics market.