Facts about FDC Drugs

Indian government banned 328 Fixed Dose Combination (FDC) drugs with immediate effect.

These drugs are prohibited from manufacture for sale, distribution and sale.

Some popular drugs included in these banned drugs are Saridon, D-cold total, Panderm cream, Gluconom PG and Corex.

Here are some important facts about FDC Drugs:

• FDC drugs refer to the combination of two or more active ingredients in a fixed dosage ratio.
• Government banned these drugs on the advice of Drugs Technical Advisory Board (DTAB).
• As per advise of this panel, these FDCs do not have any therapeutic justification. Moreover, there are potential risks of using them.
• India has nearly 2,000 FDCs compared to the US where only 500 are there.
• In addition to the 328 drugs, 6 more FDCs have also kept under scrutiny by the government to be restricted for sale.
• With the ban of these FDC drugs, around 6,000 brands of medicines include painkillers, anti-diabetic, respiratory and gastro-intestinal medicines are banned.
• The DTAB recommended these drugs as per the Drugs and Cosmetics Act, 1940. Earlier, in 2016, when the health ministry tried to ban them, the pharmaceutical companies brought this matter to the court.
• Mixing two drugs result in a new medicine. Pharmaceutical companies have to apply for a fresh license for new medicines from the Drugs Controller General of India. They also have to prove its safety by conducting trials after which they would enter in the market for sale.
• If the drug contains a single component or if it is an individual drug, then the companies will have to take permission of central government. But, companies make combination of drugs and get licenses from the state governments.
• Even though, these FDCs do not have any therapeutic justification, it is alleged that they are recommended by some physicians due to the hope that one of the drugs would work when they could not identify the exact cause of an illness of the patient.

Image Reference: Livemint