India has introduced a series of regulatory measures to enhance food safety, quality, and nutrition. However, industry experts argue that significant gaps remain, particularly in the regulation of nutraceuticals and health supplements.
The Ministry of Health and Family Welfare, which oversees the Food Safety and Standards Authority of India (FSSAI), has taken steps to update regulations. Former FSSAI director Pradip Chakraborty confirmed that a Joint Parliamentary Standing Committee has been established to assess FSSAI’s functioning and recommend updates to its Act, rules, and regulations. This committee has already produced a comprehensive report, highlighting areas that require further attention.
FSSAI regulations have expanded from six in 2011 to 29 today. While this marks considerable progress, Chakraborty stressed that more needs to be done to support the food and nutraceutical industries. A key issue remains the lack of clarity in distinguishing food from drugs, particularly in the case of health supplements and nutraceuticals. Regulatory ambiguity allows some drugs to be marketed as foods, creating compliance challenges. Unlike pharmaceuticals, nutraceuticals do not require clinical trials, and FSSAI has yet to issue guidelines for their testing.
Challenges also persist in the classification and formulation of multivitamins. Sandeep Gupta, founder and director of the Expert Nutraceutical Advocacy Council (ENAC), pointed out that categories like Food for Special Dietary Use (FSDU) and Food for Special Medical Purposes (FSMP) lack clear guidelines. The requirement for a product to have 30 years of global market history and 15 years of history in India is another major roadblock. This requirement creates contradictions, as genuinely new products cannot meet the 15-year threshold in India, delaying innovation.
According to Gupta, regulatory inefficiencies also arise due to the approval process. Each company seeking approval for the same ingredient must apply separately, resulting in duplication and inefficiency. He suggested that FSSAI should maintain a regulatory schedule listing approved ingredients along with their concentration, quality, and usage standards.
The misalignment of India’s regulations with global standards is another concern. India imports many products from Europe and the United States, yet discrepancies in standards create trade barriers. Chakraborty noted that India’s Recommended Dietary Allowance (RDA) levels are significantly lower than those set by the U.S. Food and Drug Administration (USFDA), leading to the rejection of many imported products. He advocated for harmonizing Indian regulations with USFDA and European Food Safety Authority (EFSA) standards to facilitate trade and industry growth.
Despite these regulatory hurdles, the nutraceutical industry in India is expanding rapidly. Currently valued at $8.5 billion, the government aims to grow it to $100 billion by 2030. Experts agree that achieving this goal requires comprehensive regulatory reforms and industry-friendly policies.
India continues to take a conservative approach to food safety regulations. Gupta emphasized that the regulations introduced in 2013 and revised in 2016 have been beneficial, but existing gaps need to be addressed through a structured consultation process involving industry experts and international regulatory bodies.
Meanwhile, FSSAI has introduced several initiatives to improve food safety, including updated labelling and display regulations. In November 2024, it launched the Food Import Rejection Alert (FIRA) portal, which allows authorities to take swift action on health risks associated with rejected food imports. The effectiveness of this initiative remains under review, with FSSAI CEO Shri Rao discussing its impact with state food safety officials on January 22.
While these measures indicate a proactive approach, industry experts maintain that aligning domestic regulations with international standards will be crucial in driving sustained growth and innovation in India’s food and nutraceutical sectors.