India says no to extending drug patents in UK, EU trade talks

India has made it clear that it will not compromise on intellectual property, regulatory data protection, and patent extension as part of ongoing trade negotiations with the UK and the European Union. The move is intended to protect the country’s generic drug industry, reports The Pharma Letter’s local correspondent.

There has been some uncertainty over whether India needs to tighten its intellectual property rights (IPR) regime, especially regarding data exclusivity rules, which provide protection for clinical test data submitted to regulatory authorities for the purpose of proving the safety and effectiveness of new drugs.

If agreed on, it would mean that Indian generic drug manufacturers would have to repeat the lengthy and costly tests that were conducted by the innovator companies.