- The is no guarantee that Indian companies can reproduce a drug that is as safe or effective as Gleevec
- The Indian Supreme Court dissuades foreign investment from working with Indian drug companies to improve drug quality
- Increasing access to medicines of uncertain quality is hardly a victory for public health
The Indian Supreme Court’s decision on Gleevec will surely help some patients seeking affordable treatment (“US should tighten rules for patenting changes to drugs,” Editorial, April 8), but there is no guarantee that local companies can reproduce a drug that is as safe or effective as the original, especially when they have no data-sharing agreement with the company that designed it.
Quality assurance depends on India’s drug regulator, which is plagued with problems; a parliamentary report last year accused the agency of extensive corruption and misrepresentation of pharmaceutical drug data.
Foreign investments in India are one of the strongest tools to counteract these corrupt forces — by working hand-in-glove with Indian pharmaceutical companies and government agencies to improve oversight, information-sharing, management, and product quality. The court’s decision will discourage these investments.
That should be a concern for anyone celebrating the Gleevec decision. Increasing access to medicines of uncertain quality is hardly a victory for public health.
Dr. Roger Bate is a scholar at the American Enterprise Institute.