October 07, 2010

FDA concerned over tall claims in medicine advertisements

The directorate of food and drugs administration (FDA) has warned citizens against self-medication goaded by medicine advertisements that not only make false claims but are also illegal.

To counter such advertisements, the FDA placed an advertisement recently, which read. "A number of advertisements are appearing in the print and electronic media regarding Ayurveda, Siddha, Unani ( ASU) medicines and herbal products making exaggerated claims on curing certain disease conditions; such misleading advertisement cheat the public leading to their exploitation by unscrupulous manufacturers/agencies."

FDA director Salim Veljee told TOI, "According to the schedule of Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, advertisements for conditions like obesity, sexual impotence, cancer, diabetes, etc. are prohibited. The Act says nobody can make such claims of curing the diseases in the schedule. Such advertisements are being placed in the local media."

Veljee shows a recent advertisement in the print media for an Ayurvedic oil, which promises cures for quick discharge, nightfall, impotancy (sic!), gonorrhoea, syphilis, infertility, etc. "100 per cent successful treatment for these problems," the advertisement claims. The schedule of the Act mentions a list of 54 diseases including AIDS, cancer, heart diseases, brain disorders, rheumatism, stature of person, sterility of women.

Veljee says, "The main objective of the Drugs and Magic Remedies Act is to ensure that people do not resort to self-medication. If somebody goes to a doctor, who examines him and then prescribes medication, we have no issue. But people taking drugs solely on the basis of advertisements can be dangerous."

The Act itself explain its objective thus, "The main object and purpose of this Act is to prevent people from self-medicating with regard to various diseases. Self-medication in respect of diseases of serious nature mentioned in the Act and the Rules has a deleterious effect on the health of the community and is likely to affect the well-being of the people."

The Act continues to explain that some advertisements tend to encourage the reader to resort to self-medication due to its exaggerated nature and therefore it was thought necessary, in the interest of the public, "that the puffing of advertisements is put to a complete check and that the manufacturers are compelled to route their products through recognized sources so that the products of these manufacturers could be put to valid and proper test and consideration by expert agencies."

Veljee says that for the FDA to act, the advertisement must name both the drug and the diseases. The FDA has filed about 4-5 cases under the Act in the last 10 years. Two cases were convicted with fines of 1,000 each and 3 cases are under trial. While one advertisement was of a fish for the cure of ashtma at least two promised cures for sexual impotence. Sadly, the Act being old, the punishment is imprisonment of 6 months or fine, which is not specified. Mostly courts award a fine of 1,000.

The FDA tests these advertised medicines for the active ingredients as mentioned on their labels. It has no yardstick to check their effectiveness. Recent tests by the FDA on so-called Ayurvedic medicines did not show the presence of allopathic ingredients. So the FDA is sensitizing the media and urging them not to accept such advertisements because according to the Act, the media is also responsible for the advertisements, Veljee said.

Link: Original Article

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