Drug Technical Advisory Board said there is no therapeutic justification for the ingredients contained in the 328 fixed-dose combination or FDC drugs.
A fixed-dose combination or FDC drug contains two or more active ingredients in a fixed dosage ratio. It means it’s not the single drug but a combination of the two or more, which may be unnecessary for consumption.
- Antibiotic resistance: Most harmful impact can be because of antibiotics in FDC.
– Logic is simple. If some one is not able to recognize, whether it is a rat, cat, dog or tiger causing trouble, carpet bomb with combination of three or four bombs. Is it overuse of weapons? Yes, it is. Similarly, abuse of multiple antibiotics has potential to cause massive antibiotic resistance, can have global harmful effect.
–Quacks or by self medication, antibiotics may be overused and abused . Quacks or alternative medicine doctors often prescribe FDCs as they are unable to pinpoint the exact cause of an illness and carpet-bomb patients with combination doses, in the hope that one of the drugs would work.
- Overuse of drugs: where one drug for example a paracetamol is required, patient will take three medicines.
- Increase in side effects: instead of one medication, patient will have side effects of all other medicines also.
- inadequate doses: If many drugs are combined in one, doses may be inadequate or less. So patient takes more drugs , but in adequate doses.
- Increase in cost: instead of one , the patient pays for three drugs, thereby increase in cost.
Painkiller Saridon and skin cream Panderm are among 328 fixed-dose combination or FDC drugs banned by the government to stop their “irrational use”. The health ministry says the ingredients in these medicines do not markedly add to the benefits that people can get from taking them. The order immediately bans the manufacture, marketing and sale of several common cough syrups, painkillers, and cold and flu drugs. The country’s drug advisory body, the Drug Technical Advisory Board or DTAB, has said there is no therapeutic justification for the ingredients in these drugs and they must be banned in public interest.
-The government has added restrictions to dosage and use of six more FDCs, not among the 328 banned ones, over their ingredients having no therapeutic value and posing a risk to consumers.
-The health ministry took the decision after the country’s top drug advisory body, the Drug Technical Advisory Board or DTAB, in a report said taking the 328 FDCs would be a health risk. India has some 2,000 FDCs as against a little over 500 in USA.
-It is a good move for public health. Individual drugs are approved by the centre, but some manufacturers make combinations of two drugs and get state licences.
-Mixing two drugs create a new medicine. For new medicine , pharma companies should approach the Drugs Controller General of India and apply for a fresh licence, conduct trials and prove safety.
-In March 2010, the government restricted sales of 344 FDCs, a move that was challenged by pharma firms in court. The Supreme Court last December told the DTAB to ascertain whether FDCs should be banned from the market.
Every one is calculative about the loss of millions. The invisible losses to human kind are still to be calculated.