A section of drug regulatory officials in Tamil Nadu and Kerala has expressed grave concern that offenders of various drug laws are getting away with minor punishments from courts. A fine of Rs.500 or a maximum of six-month jail term is what is usually granted for selling any unlicensed medical device or product with medical claims in these states.

The regulatory officials told Pharmabiz that the existing rules for drug control were toothless to punish firms selling unauthorized medical devices with fake claims. One main reason for not initiating tough action against such firms, like Conybio Healthcare despite actions by Gujarat and Maharashtra FDCAs is this inadequacy of rules.

The officials said that they were aware of the rules and could book firms like Conybio under Section 3 (d) of the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, for marketing products through misleading therapeutic claims.

However, as per the existing laws, the maximum punishment that could be awarded to the authorities of these firms would be a maximum imprisonment of six months or a fine.

"I agree that everyone knows most of these are products with fraudulant claims. Normally, courts let off those booked under this section with a warning and a fine of say Rs.500 or Rs.1000. So, why should we take on the wrath of those multinationals or big firms with money power and clout at various levels, for a futile cause," asks a senior drug official from Kerala.

Sources said the Drugs Controller General of India (DCGI) formed a committee four years ago to look into the futility of this section of the act and recommend suggestions to strengthen the act. However, nothing happened thereafter. The officials said they were unsure whether the committee had submitted their suggestions or not.

The officials in Tamil Nadu told Pharmabiz that the claims of Conybio marketing its Far Infra Red Rays with claims of curing some diseases could not be booked under the existing laws as only three or four devices have been mentioned as 'medical devices' in the drug law books, including information on new additions from time to time.

Two weeks ago, the Gujarat FDCA had seized various products promoted and marketed by the Chennai based multi level marketing company Conybio Healthcare for claiming to cure serious diseases. The seized products included pamphlets claiming to cure diabetes, blood pressure, Parkinson's disease, spondylitis, paralysis, piles, cancer etc. through Far Infrared Rays. The company was also said to be marketing pillow covers for Spondylitis, bed sheets for paralysis, T shirt for high and low blood pressure, palm guards for Parkinson's disease and brassieres for breast cancer. Following this, the Maharashtra FDCA had raided the premises of two stockists of Conybio in Mumbai, and had seized Rs.10 lakh worth products.