The Organisation of Pharmaceutical Producers of India (OPPI), an association mainly representing the research based multinational pharma companies, has decided to take up the issue of Data Exclusivity (DE) for clinical trial details before the Central Drugs Standard Control Organisation (CDSCO) and try to get DE clause included in the impending Schedule Y amendment of the Drugs and Consmetics Act. It is known that the OPPI has planned an interaction with the regulatory authorities on April 30th to keep them informed of the organization's views on the subject.

Data exclusivity has been a matter of dispute between multinational companies and Indian pharma companies for long time now. The OPPI will also initiate countrywide debates and discussions on the need to have a proper system for Data Exclusivity for protecting the proprietary nature of the clinical data supplied by the R&D companies. The Organization feels that data exclusivity can enhance the country's capability in clinical research.

The OPPI feels that without data exclusivity, research would be skewed in favour of patentable products and away from new uses or indications of non-patentable products. “Data exclusivity ensures that the regulators receive the detailed product information for new products that they need to ensure the safety and efficacy of drugs before approval. While the data does not become public after the expiration of the fixed period during which the health authorities are required to respect data confidentiality data, competitors are allowed to reference the proprietary data, which remains on file with regulatory authorities after the expiration of the period. At that time, the generics need not duplicate the extensive tests undertaken by the originator's drug but need only show bioequivalence of their product. By this the cost of the generics will be lowered, while the proprietary nature of the originators data is respected”, they explain.

Allaying the commonly expressed fears of the small-scale drug sector on the inclusion of data exclusivity clause, OPPI stated that DE would have “marginal impact” on the SSI sector. The only impact “ on the operation of Indian generics-regardless of their size- will be on the timing of the launch of their generics. Assuming that the original product is not under patent, the generic will have to wait until the expiration of the period of exclusivity before its copy can receive marketing approval from the regulatory authorities,” they say.

Addressing an interactive session held here on Monday, Ramesh Subrahmanian, Managing Director, Aventis Pharma India said that India has a great role in clinical developments provided a proper DE is in place. “There is a huge opportunity before us to take patent-expired medicines and look for new uses. If it has to happen, companies operating in the country need exclusive rights to the data generated by them, he said. He said that the current practice of giving approvals for copycat versions completely relying on the originators data (or even without that) poses health hazards to the public at large.

Ajit V Dangi, director general, OPPI also stressed on the threat it poses to consumer safety and needed DE protection to the original inventors of the drug.