Pharma And Medical Devices Industry Urged Govt For Faster Regulatory Clearances

Pharma and medical devices industry have now requested the government to give a clear roadmap ahead after sorting out issues like pricing, faster regulatory clearances, among others. Specifically, the pharma industry has requested a differentiated GST and reduced dependence on active pharmaceutical ingredient imports to revive its domestic manufacture.

Since the government is keen to support innovation and ‘Make in India’, the industry requested rationalization of regulation and greater transparency in the working of NPPA. The key demands which resulted from the medical devices sector were to adhere to globally harmonized standards of ISO and IEC for patient safety should be separated from Drugs and Cosmetics Act and a dedicated Act and policy for the sector.

Further, the industry required an early decision on Trade Margin Rationalization and requested to change the current price control mechanism to ‘Value-Based Healthcare’ approach, focusing on long-term health outcome and innovation.

The medical device industry has pressed the government that ICMED-type India-only standards should be stopped and India must comply by globally harmonized standards like ISO and IEC which will enable Indian firms to export medical devices and ensure the safety of Indian patients. They asked for the government to separate medical devices from drugs through a new Act and think of a Medical Devices Policy.

The industry which had several rounds of discussions with the government officials drove by Minister for Chemicals and Fertilizers Ananth Kumar during the recently closed 3-day India Pharma 2018 and India Medical Device 2018, said that the event provided a national platform for key stakeholders in the medical devices and pharma to assemble under a single roof and brainstorm the issues facing the industry and the road ahead.

“The challenge before the pharma industry is whether it can manufacture inexpensive pharma products and medical devices of global guidelines,” the Minister asked.

The Indian pharma market is set to rise as the 6th biggest pharma market globally by 2020. India needs to use its strength and leadership position in the manufacture and supply of high-quality generic medicines to improve access to medical care, industry leaders said.


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