The Confederation of Consumer Vigilance Centre (CCVC), a Thiruvananthapuram based NGO, may soon initiate legal proceedings against the Kerala drug control department for not initiating action against some multi level marketing companies selling products under the guise of nutraceuticals and medical devices with unproven therapeutic claims.

Talking to Pharmabiz, A.Ayyappan Nair, general secretary of CCVC, said that the PIL would be to force the Government to bring in necessary legislations to prevent sale of drugs through MLM network and to bring in a framework of ethical business route for such companies.

"Apart from Conybio, big multinationals like Amway, DXN, Quantum, Modicare etc. have been raking in crores of rupees for many years through sale of these 'food supplements' sold at exorbitant prices. Numerous other MLMs have mushroomed in the last few years. Many of these companies claim their products can cure one or more diseases. Then why should we have hospitals, medical practitioners, drug companies, drug rules etc," asks Ayyappan Nair.

He notes that for example, DXN sells Rishigano (RG) and Ganocelium (GL) capsules made from Ganoderma, with claims of immunity enhancing and properties to cure multiple diseases. The combined 90 capsule package costs Rs.1520, and the company indirectly says it could cure almost all diseases. It circulates literature with dosage forms, diseases applicable, curative properties, testimonials of doctors and patients, etc. The company also sells products like DXN Andro - G, 'a traditional herbal food used mainly to reduce body heat and for detoxification purposes', RG and GL Powder for wound healing etc.

Similarly, Quantum sells Amytrim natural trim care capsules with claims to promote cholesterol metabolism, reduce fat from subcutaneous folds and management of pain and inflammation associated with hyper-cholestremia. Its other Ayurvedic products include Vitagenic high energy capsules made from 17 rare herbs to purify blood and blood tissues, removing allergy causing impurities as well as eradicating bacteria and viruses. Its Osteocare capsule claims to offer defense against rheumatoid, arthritis, osteoporosis etc, Oxarid capsules for immunity against infections and to protect the body system from the effects of alcoholism and fatigue, anti-ageing etc., Malabar Tamarind for weight control and fitness, Chyavana Forte tonic for convalescence, respiratory and liver disorders, Riliph oils for arthritic pains, cough syrups etc.

Similarly, Amway sells various vitamins and iron tablets in its Nutrilite series, Glucosamine tablets priced Rs.2699 for 120 tablets, Triple Guard etc. (The Kochi warehouse of the company was recently raided by the drug officials and the company obtained a court stay to continue sale of its products).

Ayyappan Nair notes that food supplements had its origin in the US, and the US FDA amended its Drugs and Cosmetics Act in 1994 to bring in a separate Nutritious Supplementary Act to regulate marketing of food supplements. When sold as a nutritional product or food supplement, the companies need not take drug license and can escape the DPCO and other regulations, to price the product according to their will.

As per the drug laws, any product with claims and suggestions of curative properties, dosage prescriptions, treatment, diagnosis and immunity to diseases should be termed as drugs, and should be dispensed only by a qualified medical practitioner. Most of the claims lack scientific validation, and it is easy for the companies to claim an Ayurvedic license when added with a few herbs or medication as mentioned in ancient traditional texts. Unless the Government brings in a separate law for nutraceutical manufacturing and marketing, and guidelines to regulate the working of MLM companies, these companies would keep on exploiting millions of people, said Ayyappan Nair.