Union Health Ministry finally banned around 328 Fixed Dosage combination’s manufacturing, selling and distribution on Wednesday, September 12. Fixed dosage Combination refers to a mixture of two or more active drugs in a single dose form. This action to ban these medicines is taken under section 26A of Drugs and Cosmetics Act, 1940. This decision finally brings an end to the battle between health ministry and the manufacturers of these drugs which started in 2016. This decision leads to ban of around 6000 brands including painkiller, anti-diabetic, gastro-intestinal medicines, etc.
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On March 10, 2016, government banned 344 FDC’s and later on added 5 more in the list. However, these drug manufacturers opposed this ban by reporting in many high courts and also in the Supreme Court.
On December 15, 2017, Drugs Technical Advisory Board was asked to examine all these drugs. In it’s report, DTAB stated that there were some ingredients in manufacturing of these drugs which are not required in them, thus their presence was not justified, and asked government to ban these medicines in the market as they harm people.
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Ministry also banned many popular drugs like Saridon – a painkiller, Pander – a skin cream, Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ. The ministry has restricted their manufacturing subject to therapeutic justification. The use of these popular brand medicines, their composition and side effects are as below –
Saridon was earlier used to get relief from a headache. This formulation contains around analgesics propyenazone and paracetamol and stimulant caffeine. It’s over dosage leads to side effects like sever abdominal pain, yellowing of eye and skin, etc.
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Pander cream is used treat redness, itching, allergic reactions of skin. It’s composition includes Clobetasol, Ofloxacin, The and Ornidazole. Applying Panderm+ cream leads to experiencing a burning sensation ,skin redness, sore throat, etc.
Gluconorm PG 2 tablet Pr comprises of Glimpiride, Metformin and Pioglitazone used to treat type 2 diabetes. Though it claims enhance positive effect on diet and exercise of diabetic patients but it might lead to kidney or liver disease too.
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All India Drug Association has welcomed this decision and requested a final decision on 15 more exempted drugs soon. They also informed that banned drugs approximately creates a revenue of at least 2,500 crores and that in Indian Pharmacuetical market of India, these FDC’s alone have a share of one-fourth of total.
