Both online and offline manufacturers and retailers will be subject to regulation to ensure that over-the-counter sports nutrition products sold in India do not contain illegal performance-enhancing substances.
The FSSAI has published a document on the new guidelines, which details requirements for manufacturers and retailers when it comes to registration, licensing, labels, claims and traceability.
It is mandatory for these companies to comply with the World Anti-Doping Agency’s (WADA) methods, which are revised annually.
Representatives from India’s Narcotics Control Bureau (NCB), NADA, and the Sports Authority of India (SAI) worked with the FSSAI to help develop the final guidelines, which are now open to consultation.
The document states that pharmacological ingredients not approved by “any governmental regulatory health authority for human therapeutic use”, (such as discontinued drugs, drugs under pre-clinical or clinical development, and substances approved solely for veterinary use) are “prohibited at all times”.
Anabolic agents, such as androgenic steroids, are prohibited, as are peptide hormones, growth factors, glucocorticoids, beta-blockers, and hormone and metabolic modulators.
Most diuretics, as well as all cannabinoids — except cannabidiol — are also prohibited.
There are, however, what the document refers to as TUEs (Therapeutic Use Exemptions), whereby a supplement containing a prohibited substance (or its metabolites or markers), or its consumption, possession or administration, may not be considered a violation of anti-doing regulations.
This applies if the supplement or its consumption, supplement or administration are in accordance with WADA’s TUE provisions.
Labels and licences
In addition to registering with or obtaining a license from the FSSAI, sports supplement manufacturers are required to adhere to specific labelling rules.
Their products must be labelled as “intended for sportspersons”, and must carry the disclaimer that they are “not recommended for infants / children”, as well as the declaration that they do not “contain any prohibited substances as per WADA”.
The FSSAI will also audit manufacturing facilities periodically.
Online retailers will also be closely monitored, and must state the expiry date of their products, provide supply chain information via online invoices, offer “dedicated customer support”, and display manufacturers’ licences online.
Offline retailers must have their requisite licences on hand, and be prepared to provide information on supply chain traceability via retail invoices. They must also have “readily available records of the products / inventory for inventory audit sold through retail outlets”, and ensure proper storage conditions for all products.
A persistent problem
In 2015, a WADA report listed India as the world’s third biggest doping violator (after Russia and Italy), after 117 of its athletes failed their drug tests.
In September that year, the FSSAI signed a five-year agreement with the National Anti-Doping Agency (NADA) to install facilities in its laboratories to test for the restricted or illegal substances in food and nutritional supplements.
It was reported in 2017 that the Indian government was discussing a new legislation to make athletic doping a criminal offence, with the proposed law applicable to manufacturers, suppliers, and sports coaches.
Last August, the All India Council of Sports president Vijay Kumar Malhotra called attention to the prevalence of athletic doping in the country last August, and revealed he had also approached the FSSAI to discuss the issue.
In addition to stricter legislation against prohibited substances in sports nutrition products, as well as athletic doping, he proposed more widespread and improved education on doping, as many athletes tend to take over-the-counter supplements without knowing enough about their ingredients.