Audit of Indian Nutraceutical Companies – Next on USFDA Agenda

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US FDA may embark on an intensive audit of all Indian production plants engaged in the manufacture of dietary supplements covering health ingredients and nutraceuticals. The key objective is to ensure compliance of facilities adhering to its FDA 101: Dietary Supplements norms of 2008.

The drug regulatory authority will specifically look at 21 CFR Part 100 and 111 in the dietary supplements guidelines focusing on current Good Manufacturing Practice in production, packaging and labeling which are critical in marketing and recommending to the medical fraternity and consumers.

The dietary supplements include vitamins, minerals, amino acids, botanicals, as well as other substances that can be used to supplement the diet. Some ingredients and products can be harmful when consumed in high amounts and taken for a long time, or when used in combination with certain other drugs, substances, or foods. The supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. It is also suggested by the regulatory authority that health care professionals should be consulted before using any dietary supplement.

At least five companies of Bengaluru are identified for audit by the drug regulatory authority. With the increasing healthcare costs, fast changing lifestyle, ageing population and rising interest in attaining wellness through diet, nutraceuticals has emerged as one of the fastest growing industry segments in the country according to an official.

Early this year, Drugs Control General of India (DCGI) was looking to appoint an expert committee to look into the nutraceutical manufacture and regulatory norms to ensure industry complies with the highest quality standards. The industry has also asked DCGI for more clarity on the same.

Almost every pharma company has a dedicated nutraceutical and dietary supplement portfolio. Current market size for nutraceuticals and health ingredients is pegged at around Rs.4,500 crore in India registering an annual growth rate of 25 per cent.

Leading players are British Biologicals GSK, Piramal, Abbott, Sun Pharma Herbalife, British Biologicals, Amway, Nestle Nutrition, Sami Labs, Biogen Phytotec Extracts, Green Chem, Parrys and DSM Nutrition.

There is a huge awareness for wellness driving the growth of this sector. Therefore the USFDA is closely monitoring the contents on the label and comparing it with the actual contents in the nutraceutical bottle or tin or packet.

The industry expert also pointed out that in the interest of the consumer health and well being for prevention of diseases and a patient’s rejuvenation phase, India too needs a dedicated set of guidelines for dietary supplements. There are several herbal formulations in the market which need scrutiny. So far it has been difficult for the regulator to classify products as nutraceuticals or as a drug going by the contradictory claims made by the companies through the labels and advertisements.

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