The government has restricted the manufacture, distribution and sale of 328 Fixed Dose Combination drugs (FDC drugs) for human consumption. It has also put restrictions on the dosage and use of six more FDCs which are not among 328 banned ones.
The Health Ministry took this decision on Wednesday, under Section 26A of the Drugs and Cosmetics Act, 1940 on the recommendations of the Drugs Technical Advisory Board (DTAB). According to DTAB, there is no therapeutic justification for the 328 FDC drugs ingredients. Considering the drugs to be “irrational”, the panel reported that the FDCs posed a risk to human life and can cause toxicity as they are structured without due care using mismatches.
Here Are 10 Important Facts About 328 Fixed Dose Combination Drugs
- FDCs are two or more drugs combined in a fixed ratio into a single dosage form.
- Experts maintain that many of these drugs do not have rational benefits and their unnecessary use can make the human body immune to treatment.
- Painkiller Saridon and skin cream Panderm were among the 328 fixed dose combination or FDC drugs banned by the government. The Supreme Court lifted the restriction on Saridon and two other drugs, Piriton Expectorant and Dart, on Monday after the manufacturers moved court.
- As compared to US, India has 2,000 FDCs while the former has a little over 500 FDCs.
- The health ministry’s ban on FDCs covers over 6,000 brands which include anti-diabetic, painkillers, respiratory and gastro-intestinal medicines.
- The order will spontaneously put a ban on the production of several common cough syrups, painkillers, and cold and flu drugs.
- It is expected to take two days for whole-sellers and retailers to end the sale and distribution of the banned Fixed Dose Combination drugscompletely.
- The government had proposeda restrictionon about 344 categories of Fixed Dose Combination drugs in March 2010 but the move was opposed by various manufacturers in court.
- In 2016, top pharmaceutical firms approached the Delhi High Court challenging the centre’s decision to put a ban on 344 FDCs.
- In December last year, Supreme Court ordered DTAB to research the matter. The panel was asked to analyse the issue and conclude within six months whether these drugs should continue to be marketed or not.