Supreme Court Allows Sale Of Saridon, 2 Other Drugs For Now: Centre Had Banned Saridon And 328 Other Fixed Dose Combinations Last Week
Painkillers like Saridon and 328 other fixed dose combination drugs had been banned by the healthy ministry last week. The Supreme Court however has allowed sale of Saridon and 2 other drugs for now.
328 fixed dose combination drugs, including saridon had been banned by health ministry last week
- Health ministry is trying to get such drugs banned since 2016
- Popular medicines like Sardion and Gluconorm PG have been banned
- These fixed drug combinations could pose several health risks
For now, the Supreme Court has allowed sale of Saridon and two other drugs. Last week, in a rather shocking news for those who are habitual to painkillers like Saridon... the health ministry banned sale, distribution and manufacture of 328 fixed dose combination (FDCs) drugs with immediate effect, and restricted sale, distribution and manufacture of 6 others. The move marked the end of the battle between manufacturers of these drugs and the health ministry. It is since 2016 that the health ministry was trying to get such drugs banned. Around 6,000 drugs are likely to bear the brunt of the ban. These drugs include some very popular names like painkiller Saridon, combination diabetes medicine Gluconorm PG, skin cream Panderm, antibiotic Lupidiclox and antibacterial Taxim AZ.
We ask our expert Dr Sujeet Jha about the ban, who says that this is indeed a very helpful move. "There was a need of regulation of fixed dose combinations. It is harmful to mix and match any drug until it has been tested in a scientific manner. I don't think of these combinations are prescribed by doctors. There were too many fixed dose combinations being approved lately and this needed some kind of regulation," says Dr Sujeet.
He goes on to point out that if a drug is not good enough to be exported to the European countries or the ones in the US, it should not be approved. Explaining, he says, "Gluconorm PG2 is a combination of three drugs, and all three of these drugs are approved. But the combination of these drugs has not been approved. And there is not just one, but millions of combinations which have been existing and need regulation."
Speaking of the efficacy of these fixed dose combinations, he says, "The efficacy of these fixed dose combinations may not be great. They might increase the side effect profile and may not be effective at all. Combination of antibiotics may increase a person's antibiotic resistance."
Speaking of the health ministry's move, some popular drugs have managed to escape the ban. These include popular cough syrups like Corex, D-Cold Total and Phensedyl Cough Linctus.
A fixed dose combination contains two or more active ingredients in a fixed dosage ratio. It means that not the drugs, but the combination of these drugs has been cited as unnecessary for consumption. The decision of the health ministry came after the Drug Technical Advisory Board or DTAB. The board's report stated that 328 fixed dose combinations can pose health risks. Around 2,000 fixed dose combinations are sold, manufactured and distributed in India.
(Dr. Sujeet Jha is the Director of Institute of Endocrinology, Diabetes & Metabolism at Max Healthcare)
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