Mylan Says Indian Drug Industry Needs More Transparency From FDA
- Indian drug industry working with regulator to improve process
- Mylan has ‘moved on’ from Perrigo bid, President Malik says
Mylan NV President Rajiv Malik said the Indian drug industry is starting to get frustrated with U.S. regulators over a lack of transparency in the process for resolving sanctions after a wave of actions last year halted new product approvals at many plants.
Canonsburg, Pennsylvania-based Mylan in 2013 purchased Bangalore-based Agila Specialties Pvt., and three of its facilities were among Indian drug plants to last year receive Food and Drug Administration warning letters over deficient manufacturing practices. Heavyweights Sun Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories Ltd. and a string of other domestic companies also received warning letters from the U.S. last year. Factories that get such warnings can face restrictions on producing new drugs for U.S. consumption.