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Pharma Groups Oppose Plan to Shift Nutraceutical Oversight to Drug Authority
Industry experts highlight that India's current nutraceutical regulations align with Codex Alimentarius, a global standard set by the World Health Organization (WHO) to ensure consumer safety. They note that FSSAI regulations are consistent with international practices seen in countries like the US, UK, Australia, China, Japan, and the EU.
- By Newsdesk
- New Delhi
- Jul 17, 2024
The government's plan to transfer the regulation of nutraceuticals from the Food Safety and Standards Authority of India (FSSAI) to the drug regulatory authority is facing strong opposition from pharmaceutical lobby groups and industry experts, as reported by The Economic Times. Critics argue that this proposal should be suspended until it undergoes thorough discussion.
Industry experts highlight that India's current nutraceutical regulations align with Codex Alimentarius, a global standard set by the World Health Organization (WHO) to ensure consumer safety. They note that FSSAI regulations are consistent with international practices seen in countries like the US, UK, Australia, China, Japan, and the EU.
R.K. Sanghavi, chairman of the Nutraceutical Committee of the Indian Drug Manufacturers' Association (IDMA), pointed out that many countries categorize nutraceuticals similarly to FSSAI, including vitamins, minerals, and pre- and probiotics. He emphasized that FSSAI's alignment with global practices ensures the safety of these products.
Earlier this year, a high-level committee was formed to review existing guidelines and propose a new regulatory framework. This committee includes senior officials from the ministries of health and family welfare, food processing industries, the Department of Pharmaceuticals, FSSAI, the Drug Controller General of India, the Indian Council of Medical Research, and the director general of health services. They are actively deliberating on measures to regulate the nutraceutical industry.
Following an initial meeting with industry experts in April, subsequent discussions have been limited to government officials, leaving industry stakeholders unaware of ongoing developments, according to the report.
Experts warn that removing vitamins and minerals from FSSAI’s jurisdiction could reduce the nutraceutical market by 70%. The government is also considering implementing price controls to make these products more affordable.
The nutraceutical sector, including supplements, functional foods, and beverages with added health benefits, is rapidly growing. Industry data predicts that the Indian market will expand from $4 billion in 2020 to $18 billion by 2025.
A survey by LocalCircles in February revealed that 70% of respondents regularly consume various nutraceuticals, such as vitamins and dietary supplements, with 71% of Indian households using these products routinely. However, nearly 69% do so without consulting a doctor. The survey also showed that 68% of consumers purchase nutraceuticals from local stores, while 25% buy them online, with only 31% of purchases based on medical prescriptions, indicating a potential lack of awareness about the risks of unsupervised consumption.
Furthermore, the survey highlighted strong public demand for government intervention in regulating the nutraceutical market. Approximately 78% of respondents supported capping the prices of essential nutraceuticals, such as Vitamin A and C, due to affordability concerns.