MNCs Wary Of Coming To Indian Pharma Cos For R&D For Fear Of Losing Data Exclusivity

New Delhi, July 30: | Updated: Jul 31 2003, 05:30am hrs
Singapores pharma companies are seeking Indian help in executing clinical research and trials for which the former have received contracts from western firms. But what is worrying Indian companies is why such business is not coming to them directly despite their inherent strengths to carry out the same.

The answer, may lie in offering data exclusivity as is being sought by multinational (MNC) pharmaceutical companies, feels pharma consultant and Organization of Pharmaceutical Producers of India (OPPI) director ZH Charna. He was a part of a meeting recently with a business delegation from Singapore where the latter had expressed a need for working with Indian organizations.

MNC pharma companies have been pressing for data exclusivity in India to ensure their data is secure. This has been cited by them as the primary reason for offering only limited contracts for research and trials to Indian companies.

This whole issue has been projected more as a tussle between Indian and MNC pharma companies, which is a misleading picture. Singpore is getting contracts because they have regulations to protect data. But they still need to depend on Indian intellectual capital to carry out the work, Mr Charna told FE.

The Singapore delegation met Indian health ministry officials a few days ago. The government is realising the importance of data exclusivity. If we dont think of the interests of a few companies, but the country on the whole, the potential for outsourced work is huge, he added.

While it is not easy to estimate the total clinical outsourcing business globally, Eli Lilly India chairman and managing director Rajiv Gulati estimates it to be $13 billion (Rs 63,000 crore) and growing at 15-20 per cent annually.

A Pfizer official estimates India could generate $300-500 million (Rs 1,500 - Rs 2,500 crore) such business by 2010.

Nicholas Piramal president (corporate relations) Harinder Sikka told FE, MNCs want the comfort levels that their data is kept secure and exclusive in the drug controllers office. This is the biggest deterrant to getting more work outsourced from India. We must also not mix up the issue with marketing exclusivity.

Data exclusivity entails that generic manufacturers are not allowed to rely on the data of the originator to establish bio-equivalence for a specified number of years. A minimum such period of five years is being sought in India, and is also referred to as the period where the originator gets market exclusivity.