Hyderabad: The Drugs Technical Advisory Board (DTAB) has continued the ban on about 300 fixed drug combinations (FDCs), stating that these were irrational drug cocktails and exposed the patients to unnecessary overuse risks. The DTAB found that there was a mismatch in dose combinations and this increased the toxicity in the body. The board report will be submitted to the Union ministry of health by the department of pharmaceuticals, and will be a big blow to the industry.
FDCs are given to patients suffering from fever, headache and infection. Other combinations are given to those suffering from diabetes, hypertension, cardiovascular diseases. Dr K.K. Aggarwal, vice-president of the Confederation of Medical Association of Asia and Oceana, said fixed dose combinations are generally not included in the treatment regime unless it was found that giving the ingredients separately would be difficult for the patients.
“The combinations by qualified doctors are prescribed only if there is increased efficacy and improved compliance. But, over the years, we are finding more of quacks using these medicines and that is a major problem,” he said. Among the drugs which were banned three years ago were Corex, Saridon, Vicks Action 500, Amoxycillin, Nimorazole, Nimesuilid, Benadryl and Phensedyl.
These are still available in the market as the pharmaceutical companies argued that the ban was imposed without prior notice and these products are used in Indian market for 15 to 20 years. The department of pharmaceuticals set up another committee which found that the drugs are unsafe and the combinations are risky. The committee headed by Prof. C.K. Kokate has stated that the FDCs were increasing toxicity in the body as they are overused and multiple ingredients are dumped in the body some of which are not even required.
The published literature submitted to the committee is from the over-the counter sales which were carried out in other countries and not from India. According to sources, there is no epidemiological data from India submitted to the committee. Most of the reports were “too absurd and vague,” sources said. The companies which are most affected by this decision are Cipla, Pfizer, Wockhardt, Sun Pharma whoe have more than 6,000 brands in the market in the form of fixed dose combinations....