Efforts to improve safety, quality, and nutrition in India are welcomed by industry experts, but they emphasise that the food and nutraceutical industries require significant regulatory reforms to reach their full potential.
Thank you for reading this post, don't forget to subscribe!The Ministry of Health and Family Welfare in India, which oversees FSSAI, has already taken some steps to address these issues, said former FSSAI director Pradip Chakraborty.
“The Ministry has established a Joint Parliamentary Standing Committee to assess FSSAI’s functioning and recommend updates to its Act, rules, and regulations. I am serving as an invited member of this committee, which produced a comprehensive report.
“FSSAI regulations have expanded significantly – from six in 2011 to 29 today – but more needs to be done to boost the industries,” said Chakraborty, who is in frequent contact with FSSAI in his capacity as advisor to Health Foods and Dietary Supplements Association (HADSA) in Mumbai.
The grey areas between food and drugs regulations, for example, need immediate attention.
Clear regulations needed to eliminate grey areas
“There’s a thin line between food and drugs, especially for health supplements and nutraceuticals. This poses a unique challenge for India’s nutraceutical industry. Without clear guidelines, some drugs are marketed as foods, creating regulatory ambiguity. For instance, while clinical trials are mandatory for drug approval, no such requirements exist for nutraceuticals, and FSSAI has yet to issue guidelines for their clinical testing,” said Chakraborty.
Furthermore, the classification and formulation of multivitamins also face challenges due to pending guidelines, with significant gaps persisting in categories like food for special dietary use (FSDU) and food for special medical purposes (FSMP), said Sandeep Gupta, founder and director of Expert Nutraceutical Advocacy Council (ENAC).
Another major issue is the requirement for any new product to have 30 years of global market history and 15 years of history in India, said Gupta. This creates a contradiction – if the product is genuinely new, it would not have a 15-year history in India.
These requirements not only hinder the approval process but also discourage innovation, stifling the industry’s potential. They are part of the significant gaps that have remained unaddressed for the last five to six years, according to Gupta: “The FSMP and FSDU categories, for instance, lack clarity and structure. There’s room for improvement, especially with probiotics, where the regulations could be enhanced significantly.”
For example, approved ingredients should be added to a regulatory schedule, with detailed standards for its concentration, quality, and use. But this is not always done.
“Furthermore, approvals are often granted in isolation, indicating a lack of transparency. If 20 companies seek approval for the same ingredient, they do so individually. This results in duplication and inefficiency.” said Gupta.
“While we’ve developed a base regulation, we need to continually add value in a structured, consultative manner.
“For instance, guidelines could include explicit lists of permissible ingredients and their minimum and maximum usage levels under FSDU,” said Gupta, adding that many ingredients that are widely accepted globally are still not allowed in India.
The lack of alignment with global regulations could also hamper growth and innovation, making it challenging for new technologies, delivery systems, and products to enter the Indian market.
For instance, many advanced products and delivery formats available globally are not yet accessible in India because of regulatory delays. Aligning Indian regulations with international standards will encourage innovation and attract global players to India.
Change needed for industry growth
Chakraborty similarly highlighted the need to harmonise standards with the US Food and Drug Administration (USFDA) and the European Food Safety Authority (EFSA). This is because India imports many products from Europe and the USA, and both regions are significant buyers and sellers of Indian food products.
Currently, the challenges stem from discrepancies in standards. For instance, what is permitted by the USFDA might not be allowed in India due to differences in Recommended Dietary Allowance (RDA) levels. The Indian RDA is significantly lower than the USFDA’s RDA, leading to rejections of many products manufactured in the USA.
Addressing these discrepancies through regulatory reforms will be crucial for smoother trade and market expansion.
“It is therefore practical to harmonise standards with the USFDA and EFSA. Without such harmonisation, import and export activities face frequent hurdles, limiting growth potential that could otherwise see much greater increases.
“The nutraceutical industry is growing rapidly. It’s currently an $8.5 billion sector in India, and the government aims to expand this to $100 billion by 2030. Achieving this goal will require significant regulatory reforms and incentives to support the industry,” said Chakraborty.
India still takes a conservative approach to food safety regulations, which limits opportunities for both local and international players, said Gupta.
“The regulations introduced in 2013 – which I was actively involved in shaping with the FSSAI – and later revised in 2016, have served us well for over a decade. However, it’s time to address existing gaps rather than reinvent the wheel. The process should involve consultation, collaboration, and transparency, with inputs from industry experts and international bodies. By doing so, we can strengthen our regulations and allow innovative products and technologies to thrive,” Gupta said.
The Food Safety and Standards Authority of India (FSSAI) has been actively addressing food safety and quality standards, which include updates for labelling and display regulations and ensuring safe, quality products from e-commerce businesses.
Notably, the launch of the digital Food Import Rejection Alert (FIRA) portal in November 2024 enables relevant food authorities and stakeholders to take swift action in managing health risks. Authorities are still monitoring its efficacy, with this being one of the discussion points for FSSAI CEO Shri Rao at a January 22 meeting with state food safety officials.
Rao focused on regular updates about the final fate of rejected food consignment imports and prevailing food safety issues at the same meeting.
Such initiatives indicate a progressive and proactive approach in managing import health risks, but experts emphasised that such measures must align with broader regulatory reforms to ensure sustained growth and innovation.
