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INDIA'S RISING PHARMA EXPORTS

According to official forecasts, Indian pharmaceutical exports are expected to increase by 20 per cent in 2011, taking their overall value as high as 500 billion rupees (£6.73 billion).

The considerable rise from last year's figure of 420 billion rupees is thought to have resulted from a greater number of expired patents and wider acceptance of generic medicines around the world. Exports have also received a boost from the industry's overall emergence from the recession.

Executive director at India's Pharmaceutical Exports promotion council (Pharmexcil), Dr P Appaji, recently told the Pharma Times that over one-third of the Abbreviated New Drug Applications (ANDAs) filed globally originate from the Asian country.

Dr Appaji explained how Indian pharma exports had increased by just 4.3 per cent between 2009 and last year, but that this had been the only year in which the industry as a whole had been impacted by the recession. He added that, excluding those 12 months' trading, the Indian pharmaceutical industry had been expanding at a compound annual rate of 17 per cent in recent years.

At present, drug makers from India export to 220 countries in total, with the 56 per cent majority of shipped products being formulations, while bulk drugs account for just over 40 per cent and herbals for the remaining two per cent.

The country's biggest customer is currently the US, responsible for 22 per cent of the sector's exports, while Africa accounts for 16 per cent and the Commonwealth of Independent States (CIS) places around eight per cent of orders. Dr Appaji added that the Indian pharma sector was now looking to boost its sales to Kenya, Malaysia, Nigeria, Russia, Singapore, South Africa, Ukraine and Vietnam.

In addition, increased sales to Japan are anticipated after the recent signing – in February 2011 – of a Free Trade Agreement (FTA) between the country and India, which will scrap duties on more than 90 per cent of goods traded within a ten-year window.

After the US, Japan is the world's second-largest pharmaceutical market, yet currently represents the smallest one for Indian pharma exports. However, Japan's government is taking steps to encourage the use of generic medicines and Dr Appaji suggested that the market could account for at least five per cent of Indian drug exports within the coming three or four years.

Meanwhile, a similar FTA deal is currently under negotiation and could soon exist between India and the European Union (EU). In recent months, talks surrounding the agreement have been plagued by a series of setbacks. Particularly disruptive to proceedings have been protests from those opposed to the deal, many of whom believe it would merely be an "attack" on India's generics industry.

As part of its negotiations with India, the EU has reportedly been seeking even higher standards of intellectual property (IP) protection than those already agreed between the countries in 2005.

At this time, it granted patents for the first time ever to new medicines. But, according to a number of opposed organisations, the new, tougher requirements would enable companies to maintain prohibitively high prices on drugs.

During talks regarding an FTA between the EU and India, the European countries' demands are reported to have included amendments to Indian legislation to extend patent terms, as well as data exclusivity requirements that would prevent companies in India from registering their medicines domestically.

Dr Amit Sen Gupta, of Jan Swasthya Abhiyan, the Indian regional circle of the People Health Movement coalition, told the Pharma Times last year that his country had both a moral duty and a legal right to refuse the EU's demands. He went on to describe the proposed FTA as the "latest step in a long attack by the US and EY to shut down India's generic industry".

There is also some argument that, as the source of over 90 per cent of the HIV/AIDS medicines used in developing nations today, the impact on India and its drug exports could be far more wide reaching.

If Indian authorities were to give into the kinds of IP demands accepted by other emerging economies with the EU and US, access to some treatments could potentially be threatened.