The Maharashtra Food and Drug Administration (FDA) is likely to ban Marico’s new product, Saffola Cholestrol Control, from the market for not taking its prior approval.
Launched couple of days back, the new product claims to lower blood cholesterol by as much as 15 per cent. FDA commissioner M Ramesh Kumar told Business Standard that the product should need prior clearance from the authority.
“The company violated the rules by launching the product without any such clearance. Therefore, FDA, as the enforcement authority, can prima facie initiate action against the company, including banning the product,” he added.
He also said “There is every reason to take this matter as violation of Drugs and Cosmetics Act, against the manufacturer. We will first ask explanation from the company and may initiate action against it.”
Drugs and Cosmetics Act of India governs products with therapeutic claim. The act empowers the authority to clear therapeutic products only after clinical study.
Arnnab Banerjee, head, marketing, Marico, said the company launched the product as functional food and, therefore, compliance with Drugs and Cosmetics Act was not required.
“We have done a clinical study of the product at KEM Hospital in 49 patients and it has shown satisfactory results,” he added. Asked whether the study had received approval from the Drug Controller General of India, he said the company considered it as a food product which did not come under the purview of DGCI. The study was published in the August issue of a medical journal, ‘The Indian Practitioner.’
M Venkateswarulu, deputy drug controller general (West Zone), said the product should be classified as drug with a therapeutic property if the claim that it could lower blood cholesterol was true.”
In such a case, the DCGI clearance was mandatory, “ he added.
A Marico media statement at the time of the launch stated, “ Saffola Cholesterol Control is 100 per cent natural and enriched with the goodness of oats, barley, soy and fibre, which are important for controlling cholesterol.
Along with other lifestyle changes, consumption of Saffola Cholesterol Control is definitely a viable option to control cholesterol. The product does not change the taste of home cooked rotis in any way. It can also be added to other atta preparations such as dosas, idlis, dhoklas, halwa, ladoos, porridge and more.”