Eli Lilly, a leading US multinational operating in India, has all plans to set up its own manufacturing unit in the country. But this would happen after the adoption of the new patent regime by the Indian government, according to Manisha A Desai, Patent Attorney of Eli Lilly.

Currently, the MNC has contract manufacturing agreements with several Indian companies and is also conducting clinical trials for a number of its drugs in India.

According to reports, the company is planning to make India its sourcing hub in the near future.

“While the other countries have data exclusivity clause, it is not mandatory in India. However, we do not have an understanding with the Government of India that this is likely to happen soon. Of course, this will act as a catalyst in increasing our presence here,” Manisha said.

According to Ranjit Shahani, president, Organisation of Pharmaceutical Products of India (OPPI) and vice-chairman and managing director of Novartis India, the need for IPR is still perceived by many as being driven by external forces like WTO. The realisation has not yet come to us that this is something that we need to do for the current good of the country and its economic development.

Delivering the keynote address at the Asian Symposium on the Healthcare Industry in Hyderabad, Shahani said now that the two amendments to the Indian Patents Act had been passed, the country should gear itself for the product patents regime, which would have to be in place by 2005. “ I think that we have arrived at a stage where the debate as to whether we should have IPRs or not has become outdated. We should now really concentrate on how to equip ourselves for effective implementation of a good IPR law.

A good IPR regime brings benefits like inflow of newer and better medicines by rewarding research and innovation, increase in Foreign Direct Investment, increase in domestic R&D and increased employment opportunities for scientists and technologists.

A good law on patents should guard the national interest. The new law should be clear and unambiguous to ensure prevention of avoidable litigation. There should be a reasonable speed in granting patent. The infrastructure should be adequately manned so that the enforcement of Patent Law is effective.

The Patent Law should also provide necessary safeguards against its misuse. “ While we welcome the initiatives taken by the government, we now look forward to a third amendment of the Patent Act which should be in the nature of a consolidated comprehensive Act, codifying all the previous and newly legislated amendments. Even though India has time up to 2005 to introduce product patent legislation, a declaration to this effect will go a long way in giving a positive signal to domestic as well as foreign investors. Incorporation of such a sunset clause will enhance India's reputation as a responsible country honouring its international commitments,” Shahani said.