Reacting positively to the patents ordinance, Indian Pharmaceutical Industry said this would boost research and development and contract manufacturing.
However, a section of the industry wants more clarity on the issue of evergreening of patents. Only a new molecule, and not its various forms, should be granted patents, industry experts believe.
The ordinance, which received presidential assent on Sunday, will help India fulfil its WTO obligations and will project the country as a hub for research and development activities, clinical trials and quality manufacturing even as India becomes Trips compliant from January 1, 2005.
"Till now MNCs were reluctant to submit data to the regulator since process patent did not accord safety. Now we expect all-round growth in the pharmaceuticals sector. Increased competition will also help in improving quality of drugs," Harindar S Sikka, senior president (Corporate Affairs), Nicholas Piramal India, said.
He added that India had the highest number of UA FDA approved plants outside the US, which will give India a cost advantage.
The introduction of a composite order in the case of pre-grant opposition is expected to prevent excessive legislation.
"Moreover with the provision that companies cannot be prosecuted with retrospective effect, the government has finally admitted to the fact that some existing drugs will come under patent," Indian Pharmaceutical Alliance (IPA) general secretary D G Shah said.
But if there is one issue that unites the fractious pharmaceutical industry, it is the issue of prevention of evergreening of patents. "The government has not really addressed the issue of evergreening of patents. This will lead to a flood of litigation," Shah said.
The IPA had been lobbying to avoid evergreening. Only new molecules, and not different forms such as polymorphs, hydrates, isomers, metabolites etc, should be granted patent, the IPA believes, a concern that is shared by the Indian Drug Manufacturers' Association.