The Indian government has established a panel to evaluate the feasibility of placing nutraceuticals under the regulatory authority of the Central Drugs Standard Control Organisation (CDSCO) rather than the Food Safety and Standards Authority of India (FSSAI). This move is intended to address regulatory challenges and protect consumer safety.
Currently, FSSAI regulates nutraceuticals under specific regulations. However, challenges in implementation, interchangeable use of ingredients, and overlap in therapeutic usage have prompted discussions with CDSCO officials.
The government has formed a high-level committee chaired by the Secretary of the Ministry of Health to review these regulatory challenges and ensure consumer safety. The committee includes representatives from various ministries and health organizations.
The nutraceutical market in India is projected to reach a significant value by 2025. However, concerns have been raised regarding potential risks associated with unsupervised consumption of nutraceuticals, including drug interactions and excessive dosage.
The panel will assess the feasibility of regulating probiotics and prebiotics in both food and drug formats. Additionally, it will explore the need and possibility of bringing nutraceuticals under CDSCO's ambit, examine potential price controls, and consider GMP provisions and certification for nutraceuticals in line with drug regulations.