Mumbai: FDA wants to make violation of rules a tough pill to swallow
The toothless tiger wants teeth of steel to nail offenders. The state Food and Drug Administration (FDA) has appealed to the central regulatory body to have stringent rules, increased fines, which will be dictated by a new body at the centre. FDA also wants to make it compulsory of medicine manufacturers and suppliers to pay at least 10 per cent of the price of the seized drugs, if they are caught for illegal supply or possession.
Sources said that the new FDA commissioner Pallavi Darade wants stringent rules because violators often go scot-free after paying only a negligible amount as fine. Last week, FDA raided a medical store in Bandra and recovered drugs worth over Rs 1.4 crore that were being exported without license.
Let go after minimal fine
FDA officials said the drugs consisted of viagra, baby products and medicines for diabetic patients. Later, they also moved court against the medical store. However sources said that in such cases the violators are let go after a minimal fine, which makes them carefree regarding such violations. Presently, if someone is caught violating FDA rules, the authority registers a case and it is up to the court to provide a verdict.
"In the western countries, if any manufacturer or supplier is held for illegal supply or possession of drugs, they are fined heavily, which acts as a deterrent. Here, a violator having business worth crores of rupees is asked to barely pay a fine of Rs 10,000 or so. Why wouldn't they repeat [their act]?" questioned a senior FDA officer.
Proposing central body
The government authority also held a meeting earlier last week and decided on proposing to have a central authority that will decide on the rules, which will also list out the types of fines and their amounts to be levied on perpetrators.
"We are going to push for the authority and make it compulsory for a certain amount of fine to be deducted so that the violators are scared of the FDA. We are also requesting for to provide more power to the FDA when it handles such cases," said the officer.
Despite repeated attempts, Darade remained unavailable for comment on the initiative. But confirming the news, another senior officer said, "We will be sending the proposal next week. Maharashtra was the only state fighting to regulate the price of stents for years. Now, we would try to bring stringent rules to stop the repeated violation [of the existing rules]. It wouldn't happen in a day, but will take at least two to three years."
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