The Food and Drugs Control Administration, Gujarat, seized various products, promoted and marketed by the Chennai based Conybio Healthcare (India) Private Limited, claiming to be curing serious human diseases. The Administration has also ordered the company to stop publication and distribution of its pamphlets claiming to cure diabetes, blood pressure, parkinsonism, spondylitis, paralysis, piles, cancer etc. through Far Infrared Rays. The FDCA action was in response to a complaint made by Consumer Education and Research Society (CERS), Ahmedabad, exposing the false and misleading claims of the company.
The FDCA commissioner has also ordered raids on the premises of the company's distributor in the state and seizure of the products and the promotional materials. SP Adeshara, the commissioner, Gujarat FDCA, informed Pharmabiz that when he asked for scientific explanation from the company to substantiate their claims, the company representatives could not give any such details and confirmed that the products have never been tested in any of the scientific or medical institutions to prove the claims.
The commissioner also informed that he did not receive any reply from the head office of the company for his official letter asking scientific and clinical explanation for making such claims for the products. In the meanwhile, when a team from the company visited the office of the commissioner, they were advised to abstain from issuing misleading advertisement in violation of statutory provisions. The Gujarat FDCA initiated the action under Section 3 (d) of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 as the products are not approved as drugs at the same time the claims are under the purview of the Act.
The company distributed in the market sun shade to cure migraine and sun stroke, socks for acidity, pillow covers for spondylitis, palm guards for Parkinson's disease, eye-shade for sinusitis, T-shirts for high and low blood pressure, short pants that cure gas, acidity, prostate, piles, urinary system problems, ladies briefs for menstrual problems, bed sheets for paralysis strokes and brassieres for breast cancer.
The company is reportedly having a sales turnover of Rs 8 to 10 crore a month from across the country. However, it is surprising that no other states including Tamil Nadu, where Conybio is located, have initiated any action against this misleading healthcare business.
Adeshara said that he had sent an official letter to the Drug Controller, Tamil Nadu, to initiate necessary action against the company to prevent them from spreading misleading product promotion and also to inspect the facility, which claims to be manufacturing healthcare products, in Chennai. Though the letter was sent in August this year, the Tamil Nadu Drug Controller is not yet taken any action in this regard.
In Gujarat, the assistant commissioner, Food and Drug Control Administration, Valsad, had come across more than 30 such products of the company. Apart form prohibiting the sale of these products, the FDCA has ordered the manufacturers and stockists to stop distribution of the objectionable pamphlets and sale of the goods.
The CERS had drawn notice of the commissioner that the claims made by the company go against Schedule J of the Drugs and Cosmetics Rules, 1945, as well as Section 3 (d) of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
Based on a complaint from a reputed orthopaedic surgeon at Valsad, CERS wrote to Conybio Healthcare, on April 19 2003, to send copies of efficacy studies done and results obtained with each of the product shown in its brochure. Subsequently the society had sent a complaint to the FDCA, Gandhinagar on 22 April 2003.
Following this, the FDCA though investigated the authenticity of these 'healthcare' products, could not get any substantial information about the manufacturing of the product even from Tamil Nadu Drug Controllers office. Moreover, when the company representatives were asked to produce evidence to substantiate medical claims for its products and to provide scientific proof in support of the effect of Infrared Rays, which it claims is present in its products, the company admitted that that it had never undertaken such studies by any recognised Indian institute.
CERS has also sent a complaint copy to the secretary general, the Advertising Standards Council of India, New Delhi. The matter is being vigorously pursued by CERS with the authorities concerned, it is learnt.