What if you are told that the tablet prescribed to you by the doctor
and brought from the medical store was not a medicine at all? Strange
but true, and the Drugs Control Department is grappling with the
phenomenon.
A number of products have flooded the market, packaged like tablets, sold in conventional medical stores and produced by established pharmaceutical companies. But when it comes to the licences, they do not have drug licence at all. Instead, they are licensed under the category of food items under the Food Safety and Standards Act (FSSA), thereby giving the pharmaceutical companies freedom from all price controls and the quality standards that medicines are subjected to.
Drugs Control Department officials say that it was after the FSSA notification in 2011, that there was a boom in this trend resulting in skyrocketing drug prices.
“The Drugs Control Department has 61 cases pending against such drugs in the Kerala High Court. In each case, immediately after we seize the medicines, the company concerned will obtain a stay from the court and continue to sell the medicine. This is largely because of the immunity that the FSSA has provided. It is now easy for companies to label essential medicines as food supplements and dilute quality standards and price control,” said C S Satheesh Kumar, Drugs Controller and Licensing Authority.
Moreover, since the majority of the hundreds of pharmaceutical companies produce one or two products under this category, it is also practically impossible to track each of them,” says an Intelligence Officer from the Drugs Control Department in Ernakulam.
The Drugs Control Department is trying to bring in an amendment to its Drugs and Cosmetics Act making it mandatory for all products to obtain a certification that they are not drugs from the department if they are to get a licence under the FSSA, said the Drugs Controller and Licensing Authority.
But the All-India Confederation of Indian Pharmaceutical Industry said that if such practices are going on it was the onus of the government to take action. “There are a few companies which are resorting to this and there are a number of grey areas when one looks at this category. It is for the government to make appropriate Acts if this is done to avoid price controls on essential items or to dilute quality,” said A M D Namboodiri, Co-Chairman, All-India Confederation of Indian Pharmaceutical Industry.
A number of products have flooded the market, packaged like tablets, sold in conventional medical stores and produced by established pharmaceutical companies. But when it comes to the licences, they do not have drug licence at all. Instead, they are licensed under the category of food items under the Food Safety and Standards Act (FSSA), thereby giving the pharmaceutical companies freedom from all price controls and the quality standards that medicines are subjected to.
Drugs Control Department officials say that it was after the FSSA notification in 2011, that there was a boom in this trend resulting in skyrocketing drug prices.
“The Drugs Control Department has 61 cases pending against such drugs in the Kerala High Court. In each case, immediately after we seize the medicines, the company concerned will obtain a stay from the court and continue to sell the medicine. This is largely because of the immunity that the FSSA has provided. It is now easy for companies to label essential medicines as food supplements and dilute quality standards and price control,” said C S Satheesh Kumar, Drugs Controller and Licensing Authority.
Moreover, since the majority of the hundreds of pharmaceutical companies produce one or two products under this category, it is also practically impossible to track each of them,” says an Intelligence Officer from the Drugs Control Department in Ernakulam.
The Drugs Control Department is trying to bring in an amendment to its Drugs and Cosmetics Act making it mandatory for all products to obtain a certification that they are not drugs from the department if they are to get a licence under the FSSA, said the Drugs Controller and Licensing Authority.
But the All-India Confederation of Indian Pharmaceutical Industry said that if such practices are going on it was the onus of the government to take action. “There are a few companies which are resorting to this and there are a number of grey areas when one looks at this category. It is for the government to make appropriate Acts if this is done to avoid price controls on essential items or to dilute quality,” said A M D Namboodiri, Co-Chairman, All-India Confederation of Indian Pharmaceutical Industry.
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