'30 Per cent Of ANDAs Approved By The US FDA In The Year 2016 Are From India'

The Pharmaceuticals Export Promotion Council of India (Pharmexcil), is working on a zero-dependent manufacturing mechanism to reduce dependence on imports.The Ministry of Commerce and Industry, through Pharmexcil, has formed a committee to identify drugs imported in huge volumes from other countries, says Ravi Uday Bhaskar, Director General, Pharmexcil, in an interaction with BV Mahalakshmi, on the sidelines of FDD Conclave 2017 held in Hyderabad

- BV Mahalakshmi

What is Pharmexcil’s view on increasing pressure on the generic industry?

The generic industry is robust and constitutes 28 per cent of the total pharma market and is growing at four to five per cent CAGR. In 2015, two blockbusters going off-patent has contributed to an increase in the size of the generic market in terms of volume and value. However, we may not see such blockbusters going off patent in the next two-three years. Additionally, we will face price controls in the US. However, governments across the world, especially in the regions of thickly populated Asia and Africa are making efforts to reach a larger percentage of population. This is likely to increase the actual consumption of medicines by volumes. Besides, increased health coverage is being forecasted in the regions of CIS and LAC. Generics may see a flat performance in the developed regions of Western Europe and a very modest growth in North America.

India, being a prime generic source and covering all Anatomical Therapeutic Chemical (ATC) therapies, may be able to balance its product portfolio across continents to achieve modest growth in the prevailing situation and hold on to its premium position. I see a positive trend in the coming years, particularly in the US, as 30 per cent of ANDAs approved by the US FDA in the year 2016 are from India and seven Indian pharma companies are among the top 20 global generic players.

How to reduce import dependence and need for import restriction from China?