Reconsider raising product approval fee: Drug manufacturers to govt

They say the fees will impact SMEs the most

The Indian Drug Manufacturers Association (IDMA) has asked the Union health ministry to reconsider its proposal on raising fees for product registration, inspection and clinical trials.

“Though we appreciate the need to increase fees for import of bulk drugs to protect the local industry, we are not in favour of any hike for domestic manufacture of bulk drugs or formulations,” said IDMA President S V Veerramani during the association’s 54th annual function in Mumbai on Saturday.  

According to Veerramani, the fees will increase five to 10 times, and small and medium enterprises will be impacted the most. “We understand that fees have not been revised for the past fifteen years. But, the increase should not happen in one go. We want the government to reconsider the proposal,” he added. The central government’s approval is required for new molecules and fixed-dose combination drugs while state drug controllers grant approvals for established drugs, on payment of fees. IDMA will also be conducting courses on quality assurance for executives of pharmaceutical firms in the wake of scrutiny and warning letters from the US drug regulator.

During the occasion, Cipla’s Chairperson Y K Hamied was felicitated with a lifetime achievement award.    bs reporter

The course will be carried out in partnership with UK agency NSF and will cover topics such as good manufacturing practices, data integrity and quality management system, amongst others.