The Organization of Pharmaceutical Producers of India (OPPI) has countered this, arguing that RDP will benefit indigenous drug makers, much like multinational companies as they move up the value chain into newly researched innovative medicines.
Over a defined period of time, RDP blocks generic drug makers from relying on clinical and non-clinical regulatory data generated by innovators to develop their newly researched drugs, said OPPI director general Anil Matai. By accessing such undisclosed data, generic drug makers can launch their copies, which OPPI said is an “unfair reliance” given the significant investments and time it takes to generate the repository of scientific information, he said.
While India has not drawn investments in on-ground research labs from multinational companies yet, China has seen significant interest from top drug makers that include Pfizer, AstraZeneca, Eli Lilly and Roche among several others. The same companies have stepped up investments in India in clinical trials, building global capability centres and support functions in areas such as management of large volumes of clinical research data. OPPI said investments in discovery research can be expected if India’s regulatory structure is aligned with global best practices.
In May, China introduced the RDP clause for up to six years for chemical and biologic drugs, a move that experts say could further establish its strengths in research. Last year, China’s out-licensing deals for newly invented drugs yielded $138 billion, a 10-fold increase in value seen over a span of less than five years.
OPPI director general Anil Matai told ET that the actual cost of invention of a drug is estimated at about 25%, which is when the drug is granted a patent. But the bulk of the expense, almost 75%, goes into establishing safety and efficacy, where data is of high importance. “That is what regulatory data protection is because it protects confidential clinical, non-clinical and regulatory data,” he said.
Late last year, the Central Drugs Standard Control Organization invited comments from stakeholders “to ensure level playing field in new drug approval.” The move triggered strong opposition from civil society groups such as the Working Group on Access to Medicines and Treatments. It said RDP may lead to evergreening or extension of patent monopolies and prevent access to new lifesaving drugs at affordable rates.