1. Regulation Mess

Regulation Mess

India would do better to learn from other jurisdictions on regulating nutraceuticals

By: | Published: April 4, 2016 1:27 AM

Days after the government banned 344 drug formulations, it has dealt another blow to the pharma sector with a regulatory notice to the R20,000-crore nutraceutical (nutrients isolated from food, including dietary and herbal supplements) industry. As per The Economic Times, the Food Safety and Standards Authority of India (FSSAI) has come up with a draft set of rules that include strict testing and manufacturing norms. Though products that were being marketed before 2011 and those for which the approval was pending on August 19, 2015, when the Supreme Court scrapped FSSAI’s product approval advisory committee, have been exempted, the new rules mean any product in the market after 2011 that had not sought approval stands effectively banned till it shows compliance. This move hits pharma giants like Sun Pharma, Abbott and GlaxoSmithKline as well as the likes of Amway and Herbalife.

However, FSSAI’s severe staff and resources crunch puts its approval process under a cloud. Also, given nutraceuticals and dietary supplements—like anti-oxidants, multi-vitamins, etc—are often consumed on medical advice, their approval is better vested with the drug regulator than the food regulator. Developed jurisdictions, for long, have refused to go for a catch-all classification like ‘nutraceutical’ and have instead treated some of these as drugs, some as dietary supplements and the rest as food and food ingredients, thereby following different regulatory standards for each group. For instance, in the US, dietary supplements don’t require an approval; instead, these just have to be registered with the Food and Drugs Authority before being marketed. India would do well to take a cue from such regulatory systems instead of hastily clamping down.

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