Government Panel Reviews Nutraceuticals’ CDSCO Inclusion

Government Panel Reviews Nutraceuticals’ CDSCO Inclusion

To address the regulatory challenges and consumer safety issues in nutraceuticals, the government has formed a high-level committee under the chairmanship of Secretary, Ministry of Health to review the regulatory challenges in nutraceuticals and drugs and examine the possibility of bringing nutraceuticals under CDSCO.

The committee has as its members Secretary, Ministry of Ayush, Secretary, Ministry of Food Processing Industries, Secretary, Department of Pharmaceuticals, Chief Executive Officer (CEO), FSSAI, Drugs Controller General of India, Director General, Indian Council of Medical Research and Director General of Health Services (DGHS).

The committee will look into the pros and cons of bringing nutraceuticals under CDSCO and suggest ways to ensure consumer safety and promote the growth of the nutraceutical industry in India.

Why are they important?

Nutraceuticals are products derived from food sources that are believed to provide extra health benefits besides the basic nutritional value found in foods. They include health supplements, vitamins, minerals, probiotics, botanicals and other ingredients that are used for specific nutritional or dietary purposes.

Nutraceuticals are important for various reasons, such as:

  • They can help prevent or manage chronic diseases, such as diabetes, cardiovascular disorders, obesity, cancer and neurological disorders.
  • They can enhance the immune system, improve digestion, reduce inflammation, promote skin health and delay aging.
  • They can complement the conventional treatment of diseases by reducing the side effects of drugs or improving their efficacy.
  • They can cater to the diverse needs of different segments of the population, such as children, women, elderly, athletes and vegetarians.

What are the current regulatory challenges in nutraceuticals?

However, the regulation of nutraceuticals in India is not clear-cut, as they fall under the ambit of the Food Safety and Standards Authority of India (FSSAI) instead of the Central Drugs Standard Control Organisation (CDSCO), which is the apex drug regulator in the country.

This has led to some regulatory challenges and consumer safety issues, such as:

  • Lack of uniform implementation and enforcement of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022, which cover nutraceuticals under FSSAI.
  • Interchangeable usage of the same nutrient/ingredient at different doses for pharma and nutraceutical use, which may cause confusion and misuse among consumers and manufacturers.
  • Overlap in prophylactic and therapeutic usage of nutraceuticals along with disease risk reduction claims, which may blur the line between drugs and food products.
  • No mandatory medical supervision for products covered under nutra regulations, which may result in overconsumption or interaction with other drugs that may have adverse effects on health.

What is the future outlook for nutraceuticals in India?

The nutraceutical market in India is estimated to reach USD 18 billion by the end of 2025 as compared to USD 4 billion in 2020, according to industry data. The sector has immense potential to contribute to the health and wellness of the population as well as generate employment and revenue for the country.

However, it also requires a robust regulatory framework that can balance the interests of consumers, manufacturers and regulators. The government panel’s review is expected to provide a clear direction for the future of nutraceuticals in India.

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