Indian Small and Medium Enterprises (SMEs), specializing in the manufacture of raw materials for dietary supplements, are eyeing big opportunity in the burgeoning US dietary supplement market (valued at USD 25 billion) and are gearing up to obtain mandatory certification as imports into that country are highly regulated.

Following the introduction of the Dietary Supplement Regulation Bill in 2007, the SME segment has been finding it difficult to enter the US market. Owing to this regulation, the US dietary supplement market is dominated by large players from India.

Given the fact that the US is heavily dependent on India for supply of high quality raw materials, several US organizations are trying to build capacity of Indian SME exporters in terms of adherence to Good Manufacturing Practices (GMP) and also obtain necessary certification.

For instance, NSF International, the US-based not-for-profit public health and safety organization, is offering the GMP and dietary supplement certification through its Indian arm - NSF Safety and Certifications India Private Limited.
 
Speaking to Pharmabiz on the sidelines of the World Ayurveda Congress, Chris Aiyer, senior business development manager, dietary supplement certification programmes, NSF International, said, “GMP compliance is viewed as a cumbersome and expensive exercise for the SMEs. We would offer independent third party services that would enable Indian exporters to meet the standards acceptable by the Food and Drug Administration in the US.”
 
Indian pharma industry is known for its innovation in research and development of generics which includes multi vitamins and minerals. But the issue of mandatory international certifications is stunting their export opportunity, he pointed out. Also he stated that with the US looking at sourcing more of dietary supplement formulations along with raw materials, Indian exporters have a huge market to tap and with recognized international certifications in place exporters could hope for faster clearances from Food & Drug Administration, US.