Experts believe that bringing nutraceuticals under the purview of the drug regulator would be beneficial for both the industry and consumers. Commenting on the recommendations made by the eight-member inter-ministerial committee tasked with reviewing the regulatory framework for nutraceuticals, they noted that the recommendations overlook critical aspects like coordination between regulatory bodies and the creation of awareness among doctors and consumers.
Sumant Kumar Tiwari, Joint Director of the Jharkhand Drug Control Administration, emphasized that including nutraceuticals in the drug regulation would allow these products to be covered by insurance claims. Currently, since nutraceuticals fall under the FSSAI license, insurance companies do not reimburse claims for nutritional supplements.
However, if these products are categorized as therapeutic, they could fall under the drugs category, potentially opening the door for insurance coverage. This shift would be particularly significant given the increasing insurance penetration in India, driven by government schemes like Ayushman Bharat. Tiwari noted that this change could be a major boost for the pharmaceutical sector, especially since many nutraceutical companies are also part of the pharma industry.
He also argued that such a move could enable consumers to benefit from price control, with governments paying premiums on insurance.
Professor Bejon Kumar Misra, founder of the Patient Safety and Access Initiative of India Foundation (PSAIIF) and member of the executive committee of the General Insurance Council, agreed, stressing the importance of insurance companies covering preventive healthcare, including over-the-counter products for safety and healthcare.
However, Misra also highlighted the need for better coordination among the various regulatory bodies. He suggested that the FSSAI, CDSCO, and the Ministry of Ayush should meet monthly to discuss the approval process for products. “Health and safety should be the top priority,” Misra said. “The regulators must work transparently and collaboratively to ensure that products do not compromise public health.” He proposed the creation of an umbrella body to facilitate this exchange of information.
Another key concern raised by experts was the lack of emphasis on consumer and healthcare professional awareness in the committee’s recommendations. Misra noted that the committee had failed to address the need for widespread education on nutraceuticals.
Consumers often struggle to distinguish between drugs and food products, as both are now available in similar forms, such as pills, capsules, and liquids. This confusion, he said, underscores the importance of ensuring that medical professionals understand the standards of these products and their potential impact on health. Misra argued that regulatory standards should be communicated in simple, accessible language to help consumers make informed choices.
Furthermore, experts pointed out that nutraceuticals can pose health risks if misused, and that this issue has not been adequately addressed in the committee’s recommendations. They criticized the lack of clear enforcement mechanisms for advertisement violations and suggested that stronger penalties should be imposed for non-compliance with regulations.
The inter-ministerial committee, formed by the Union Health Ministry, recommended amendments to the Food Safety and Standards Act, 2006, and the introduction of Good Manufacturing Practices (GMP) for nutraceuticals and health supplements.
It proposed that vitamins, minerals, and amino acid supplements should not be regulated by FSSAI if they are combined or used in specific dosages. As reported by pharmabiz.com, these formulations should fall under the jurisdiction of the Central Drugs Standard Control Organisation (CDSCO), while vitamins, minerals, and amino acids added to food could remain regulated by FSSAI.