Nutraceutical Industry in Need of Stronger Regulatory Enforcement

India has witnessed a magnificent upswing in the acceptance and usage of nutraceutical products as a viable option for maintaining health.

Picture: Pixabay

Last Updated on February 20, 2021 by The Health Master

Nutraceutical Industry in Need of Stronger Regulatory Enforcement

The Nutraceutical industry is taking deeper roots in India, as the population grows to become health-conscious and aware of the benefits of natural nutritional supplements.

An industry that has often been considered to be a sub-section or an off-shoot of the pharmaceutical sector, is now receiving due recognition from its consumers.

India has witnessed a magnificent upswing in the acceptance and usage of nutraceutical products as a viable option for maintaining health.

The market has flourished into a $4 billion industry in 2017 and is expected to grow at a CAGR of 21% to become an $18 billion industry by 2025.

Also read about supplements, click here

While this has certainly given us ‘raison de célébrer’, we can’t overlook some serious limitations. Despite the phenomenal growth and the rapid increase in demand for nutraceutical products, the absence of a specific regulatory approval process, which causes delays, is increasingly being felt.

Picture: Pixabay

This gap in the system has created a state of uncertainty in the minds of nutraceutical manufacturers in India.

Also read: Overmedication: NPPA to conduct Prescription audit of FDCs

Strengthening Current Regulations

In India, it is obligatory for nutraceutical products to be registered, for the brands to market them. The Food and Safety Standards (FSS) Act 2006 provides us with the procedures that are needed for the registration of our products.

But due to the unavailability of a standard set of guidelines, nutraceutical companies in India face challenges during the registration process. After the FSS Act of 2006, a new set of rules were introduced by the FSSAI in 2011 – Food Safety and Standard Rules – in an attempt to help manufacturers.

These rules have helped in regulating the licensing and registration of food products, food business, packaging and labelling methods, standards for food products, and additives used in the food product.

The new rules have made it easier for the authorities to govern the manufacturing, distribution, and sales of nutraceutical supplements within the country. However, this is wholly inadequate when it comes to providing a permanent solution for the issues associated with the registration process.

Having a structured process of registration for the nutraceutical industry should be our central focus because it will make available preventive health solutions to the consumers at lightning speed, making the industry a lot more competitive.

Strategies for Regulatory Enforcement

Taking into consideration the idea of altering the Drugs and Cosmetics Rules (1945) to exempt nutraceuticals from the scope of the Drugs and Cosmetics Act (1940) may actually be the most effective way to overcome our current challenges.

For the industry to thrive and grow at a faster pace, it is essential that the Nutraceutical segment be treated as an independent and unique entity, and has rules and regulations designed after thoroughly understanding the functioning of the industry.

Given the size of the growing Indian nutraceutical sector, it certainly deserves to be treated as a separate entity, rather than being considered as an ‘add-on’ or an afterthought.

The Indian Nutraceutical Market is growing exponentially and India is poised to be a global leader in the nutraceutical segment in the near future, so it would be unfortunate if this growth story hits a wall merely because our regulatory framework is playing catchup.

by Sushil Khaitan
CEO & Director at

DISCLAIMER: The views expressed are solely of the author and does not necessarily subscribe to it. shall not be responsible for any damage caused to any person / organization directly or indirectly.

Also read:


Nutraceuticals in India: A game changing opportunity

Nutraceuticals: From Alternative to Mainstream

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