Dr Vaibhav Kulkarni, board member & chairman, technical committee, HADSA, opened the meet by stressing on the importance of connecting the dots between prevailing regulations and USP standards for food ingredients in India. “We do have clarity when it comes to drugs, though. As for exports to US or other regulated markets, this can be an advantage and hence the increased cost in manufacturing can be justified. But for India, we still need to define the overall process and advantage to the companies before we adapt these standards,” Kulkarni said.
Meanwhile, John Atwater, senior director, verification program, USP; Dr Nandu Sarma, director, dietary supplement and herbal medicine, USP; and Gabriel Glancaspro, vice-president, dietary supplement and herbal medicine, USP; presented on various features of USP standards, ranging from quality control, verification process, new standards and prioritisation for development and 2018-19 plans. They explained in detail all that is mentioned in USP and what the regulation requirements for dietary supplements in the US and USP standards and guidelines as tools to help and meet GMP (Good Manufacturing Practice) requirements.
Giving further insight, Glancaspro said USP is looking to develop monograph and get model updated with new streams from herbal medicine with potential as dietary supplements. As for ongoing development for 2018-19, few botanicals would be added namely cranberry and pomegranate family, ginger extract, broccoli seed extract, sour jujube seed, aloe leaf juice family among others.
Few botanical herbs are also lined up for omission for revisions and amendments like belladonna leaf, belladonna extract and tablets, and digitalis.
In conclusion, the speakers stressed on USP working on high priority ingredients. Also they mentioned that herbs which were not identified in the FSSAI standards were available in USP along with new dietary ingredients.
