The Union government and the Indian pharma industry are now concerned about the regulatory and trade challenges coming in with the implementation of the Trans-Pacific Partnership (TPP) and the Transatlantic Trade and Investment Partnership (TIPP) which was reached on October 5, 2015 after 7 years of negotiations by the 12 Pacific Rim countries that include US, Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam.

The industry will now need to prepare collectively to trade in the US and EU in the wake of regulatory and trade challenges like the Trans-Pacific Partnership that are expected to be a serious blow for the sector, said Sudhanshu Pandey, joint secretary, ministry of commerce and industry, government of India.

According to the industry, patent expiries till 2016 will reduce expenditure globally in the developed markets by $127 billion. Now the US government is looking to give the innovator drug majors an extension of over two decades together with a 12-year data exclusivity. Moreover under TPP and TTIP, these countries are viewing to support the creation and retention of jobs, enhance innovation, productivity and competitiveness which is expected to be a serious dent in export revenues.

Pandey said that the government was closely watching this as France and Geneva NGOs were already opposing TPP and TTIP.

“The pharma industry which currently constitutes a mere 5 per cent share to the total export basket of the country should now work to increase it to 10 per cent by 2020. However, there are serious impediments. The industry will need to devise strategies to increase its exports and widen its reach in the eastern parts of the world like Japan and Indonesia,” he added.

For instance, Indian pharma exports to Japan is a miniscule 0.5 per cent and efforts to expand its presence here crucial. This is because the Japanese government has now increased its healthcare budget and is looking for opportunities to collaborate with countries that are known for quality generic drug production. Therefore Indian pharma needs to increase its presence in the region, said Pandey at the India Pharma and India Medical Expo 2016, being held here from January 7 to 9.

Although the pharma industry is exporting to 200 countries and with the growing demand for generics is driven by governments of these nations, we do see several regulatory challenges that are likely to hinder growth prospects, noted Pandey.

In the case of Indonesia, the cost of medicines has gone up and  bi-lateral cooperation with India should be maximized by pharma industry here.

The free healthcare programmes in many of the countries will now see a demand for generics. India is already recognized for its capability in this space and we have seen a consistent double digit export growth, barring a fall in the same last month, said Pandey.

The industry must hasten its efforts to handle regulatory issues, educate its workforce to develop a culture to comply with the norms of various markets. Regarding the least-developed countries (LDCs) and Africa’s agenda: 2063 that was issued early this year, they are all opportunities for Indian pharma to collaborate and succeed, he said.

In November 2015, WTO has decided to extend drug patent exemption for LDCs by another 17 years, till 2033. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) has now permitted manufacture high-priced branded under patent formulations which are far cheaper to produce in these regions.