Even as the US finally came down heavily on its own e-comm companies, including the largest player Amazon, against selling unapproved drugs and consumer health products, India, a country where online trade in the healthcare segment is ballooning, seems oblivious of the same and its imminent dangers.
As per the latest available market data, about 14.2 per cent sales in India’s $5.70 billion over-the-counter pharmaceuticals market is generated through online sales currently. The online platforms, including the multinational giants and the homegrown firms, sell a wide variety of such products ranging from skin care products to supplements that could “treat” even serious ailments like cancer.
The US Food and Drug Administration, one of the most trusted food and drug regulators in the world, has early this week issued warning letters to the country’s three leading online merchandisers– Amazon, Ariella Naturals and Justified Laboratories– for introducing mole and skin tag removal products. The US FDA, while issuing the warning letters, reviewed by FPJ, said, “...there are no FDA-approved over-the-counter drug products for the removal of moles and skin tags.”
“....it is the FDA’s duty to protect public health from harmful products not approved for the US marketplace. The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities. This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law,” said Donald D. Ashley, Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
Flagging the dangers of unapproved health products such as mole removers, the FDA cautioned that moles should be evaluated by a health care practitioner. “...self-diagnosis and treatment of moles could lead to delayed cancer diagnosis and treatment, and even cancer progression…” the FDA said.
The FDA had also recently issued a consumer warning noting that products marketed for removing moles and other skin lesions can cause injuries and scarring. The sale of these products risks public health and may jeopardize consumers’ health when used without consulting a healthcare professional.
Curiously, India’s twin-layer drug regulatory system –- the Central Drug Standards Control Organisation (CDSCO) and the State level FDAs — is yet to act on the menace of rampant online trade of unapproved and unauthorised healthcare products.
“...the bigger issue that we face while acting against these e-comm sites is the lack of clarity in the existing law, which needs to be modified according to the changes in the trade practices,” says a senior drug regulatory official at the CDSCO, seeking not to be identified.
Even though the Central Consumer Protection Authority (CCPA) in July issued an advisory to e-commerce entities concerning the sale of certain products in the traditional systems of medicine such as Ayurveda, Siddha and Unani, it hasn’t really made any serious impact so far as it was in the nature of a voluntary decision on the part of the e-comm sites.
According to the US drug regulator, the mole and skin tag removal products sold on the online platforms have not been evaluated by the FDA for safety, effectiveness or quality and require FDA approval. The introduction or delivery for introduction of these products into interstate commerce without an approved application is an additional violation of the country’s (US) Food,Drugs & Cosmetics Act.
The FDA’s warning letters alert the companies that failure to adequately address the violations cited by the FDA may result in legal action including seizure and/or injunction. The companies have 15 days from receipt of the warning letter to respond to the agency with actions they have taken to address any violations, the FDA letter to the online companies said.
