Ministry bans 156 ‘irrational’ fixed dose combination drugs with immediate effect

Ministry bans 156 ‘irrational’ fixed dose combination drugs with immediate effect

Sub : Sci

Sec: Health

Context:

• The Union Health Ministry has banned 156 “irrational” fixed dose combination (FDC) medicines with immediate effect.

Reason for the ban:

• An expert committee found “no therapeutic justification” for these combinations and they may pose risk to the patients.

Fixed dose combination (FDC) drugs:

• Fixed dose combination drugs are combinations of two or more active drugs in a single dosage form.
• FDCs are also called ‘cocktail drugs’ as they combine two or more active pharmaceutical ingredients (APIs) in fixed ratios.
• While such combinations may help patients with illnesses such as tuberculosis and diabetes consume fewer pills, they also end up delivering ingredients to patients that they may not need.
• For example, patients may end up taking an antibiotic combination for fever when they only require paracetamol.
• The FDC may involve risk to human beings. Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale, or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act 1940.
• One of the reasons for the crackdown was due to some state licensing authorities issuing manufacturing licenses for several FDCs without prior clearance from the Central Drugs Standard Control Organisation (CDSCO), leading to the availability of untested and potentially unsafe FDC combination drugs.
• This action follows previous bans. India banned 344 combination drugs in March 2016 and, most recently, 14 FDCs in June 2023.
• According to the notification issued by the health ministry, the government has banned ‘Aceclofenac 50mg + Paracetamol 125mg tablet’. The list also includes Mefenamic Acid + Paracetamol Injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine, and Camylofin Dihydrochloride 25 mg + Paracetamol 300mg.
  The Centre also banned the combination of Paracetamol, Tramadol, Taurine, and Caffeine. Tramadol is an opioid-based painkiller.