The government is examining a set of proposals by global drug manufacturers seeking changes in India’s intellectual property rights (IPR) laws to reward innovation, triggering howls of protest from domestic pharmaceutical companies who said it would keep prices of many critical medicines perpetually high.
Global drug manufacturers represented by the Organisation of Pharmaceutical Producers of India (OPPI) have sought ‘legislative review’ of the section 3(d) of the Indian patents Act and a redefining of the ‘efficacy criteria’.
Section 3(d) of the Indian Patent Act restricts grant of patent for “incremental innovations,” in many drugs unless it provides significant therapeutic advantages to existing molecules.
Several patent claims of global drug manufacturers have been rejected on grounds of this provision. Domestic drug manufacturers said the OPPI proposals would mean drugs would remain patented till perpetuity and prices of many medicines would remain high.
It would prevent the launch of cheaper generic versions of a medicine whose original patent may have expired. The PMO has held a meeting with top executives representing global drug majors in May.
Generic drug refers to a cheaper copy of an original product whose patent has expired.
“The proposal moved by the PMO, if implemented, would destabilise the IPR regime by reversing. It has grave implications, not just for the domestic pharmaceutical industry but for the country as a whole,” said D.G. Shah, a general secretary at Indian Pharmaceutical Alliance (IPA), an association of domestic pharmaceutical companies.
“It would seriously compromise availability and access to affordable medicines.
The impact would be felt across the developing and the least developed countries as they are all dependent on India for their requirements of quality medicines at affordable prices,” Shah said.
In the meeting with the PMO, it was agreed that OPPI will prepare the note on these proposals.
“Give the national industry a chance to prove their capability in R&D before succumbing to the pressures of the MNCs,” Shah said.