Indian government came up with a notification banning the manufacture and sale of nearly 350 fixed dose combination of drugs. As there is a conflicting implementation of laws in India. There seems a rapid increase in the usage of combination drugs due to the approval by the state drug administration without getting a clearance from the centre.
A fixed dose combination drug refers to the combining of two or more drugs available in single dosage. Due to the availability of combination drugs it became easier to take a single medicine instead of taking several medicines which also increases patient’s compliance.
According to the doctors, the increased use of combination drug seems to be dangerous to health as there is a high risk of antibiotic resistance. The resulting effect is that when the adverse reaction happens, it becomes difficult to know which component is responsible for it. Thus, it is not safe to use these drugs for cold and fever.
In 2014, the health ministry gave pharma companies an opportunity to review more than 6000 combinations done by the expert commitee. It also gave them a chance to prove the safety and efficacy of these drugs by the submitted data.The committee tasked upon classifying the drugs as rational or irrational and those which need further studies.
Based on the responses and assessment of products nearly 300 drugs have been prohibited. Though the medicines were not named by the joint secretary healthy ministry, but an official notice is expected to be issued in a few days. It may affect the huge profits of various companies until they launch new ones to retain their sales.
The banned drugs include the codeine based cough syrups Phensedyl and Codex. These cough syrups, the former being made by U.S. Drugmaker Abott and latter by Pfizer accounts for about one third of the market generating a revenue of more than 3 percent of 1 billion.
The committee on health & family welfare in its 59th report (May 2012) found various loopholes in the approval of fixed drug combination drugs that are already banned in western countries. According to the committee, the combinations that pose risks due to the danger of developing resistance need to be withdrawn immediately. If an FDC drug is not approved anywhere in the world it should not be used in India as well unless there is a specific disease or disorder prevalent in India,or a very specific reason backed by scientific evidence.