With a sharp rise in the import of dietary supplement imports into the US, the US FDA is tightening its regulatory norms to ensure that the products entering its shores meet the stipulated norms. As formulation imports are growing at a faster rate, these products are sold Over-The-Counter (OTC) without any restrictions.
Talking to Pharmabiz on the sidelines of 4th World Ayurveda Congress being held in Bangalore, Dr Norman Howe, senior partner, Validation & Compliance Institute, said, “Import of dietary supplements as formulations are essentially targeted at the people of above 50 years of age group and as these formulations are being made by the small and medium enterprises in India with no adequate current Good Manufacturing Practices (cGMP) there is a genuine concern on the quality front.”
Adherence to cGMP among others becomes very important and along with this the availability of trained talent pool to manage a wide spectrum of issues concerning regulatory services has also assumed significance. It is against this backdrop, he pointed out that, Validation & Compliance Institute has showed its willingness to forge alliances with the Indian Ayush and pharma industry to train personnel in the areas of regulatory services.
Also an adjunct Professor of Regulatory Science at the University of Michigan, Dr Howe, stated that Indian Ayush industry’s presence in the global market is witnessing a change in format. While earlier raw materials were shipped out, now the trend is shipment of formulations and with this the dynamics are also changing that brings to focus the relevance of cGMP, other regulatory practices and finally the talent pool managing this.
While the challenge of training talent remains, there are also other concerns pertaining to raising awareness amongst the small and medium segment & mobilizing them for training, creating adequate physical infrastructure, obtaining access to qualified candidates and also forging linkages with the industry. This is where V & C Institute is targeting compliance adherence across all levels of the skill pyramid.
Further, he pointed out that the regulatory body is also facing paucity of qualified and trained inspectors. From an inspectorate perspective the component identification test is a major problem in dietary supplements. Identifying, carrying out physical and chemical tests are tough on ambiguous herbs and plant medicines. If there is some clue on whether it is a vitamin or a mineral, then there is a possibility to ascertain the contents. Since new inspections will now be time consuming because of shortage of inspectors, it is looking to tap the growing unemployed population to train them in the areas of regulatory services and mould them for new job opportunities in the regulatory space, he added.