Regulation largest barrier in pharma; Indian cos should focus on quality: Official

Mumbai: Union Pharma Secretary S Aparna on Thursday said regulations are the biggest barrier to market access in the sector globally, and exhorted local companies to focus on quality. Delivering a video message at the Eighth Global Pharmaceutical Quality Summit, Aparna backed the focus on regulations given the need to have products which are safe and effective.

"Pharma is highly regulated globally, and regulations contribute the single largest barrier to market access," she said.

"Indian manufacturing sector has wide-ranging players and the quality culture has to be built across the range," she said.

Aparna said Indian industry, which has a very large number of small and medium businesses, is essentially a generic market, and stressed the need to innovate as per changing disease profile and other factors.

"Indian pharmaceuticals have scale, cost and quality advantages which have enabled companies to make a mark and garner market share in all countries across the world. Cost competitiveness cannot be the single factor ensuring continued growth for any industry or sector," she said.

There are challenges like the ones on technology, resources and skills which the industry needs to grapple with in order to become a part of a uniform and homogeneous quality ecosystem, she said.

The government has launched the pharma technology upgradation assistance scheme which is targeted at such small businesses itself and help them innovate, she said.

"Quality is the paramount parameter for the future growth of the Indian pharmaceutical industry, both for domestic and global markets," she said, adding that the primary responsibility for ensuring it lies with the manufacturers themselves and the industry lobby grouping IPA also needs to play its part.