After the biggest crackdown on drugs since 2018, when center has prohibited 344 such combinations marked as “irrational”, once again center has banned 156 more fixed dose combination (FDC) drugs because they are “likely to involve risk to humans”.
How Did This Happen?
When it comes to the FDC drugs, it contains a combination of two or more active pharmaceutical ingredients (APIs) in a single form, usually manufactured and distributed in a fixed ratio.
They have banned these combination drugs through a notification on 12 August.
This included several antibiotic combination medicines which were used for fever, allergies, colds, skin disorders, and pain, among others, that are widely sold.
To be specific, this newly banned batch of FDCs include combinations like cetirizine and phenylephrine hydrochloride; levocetirizine and phenylephrine hydrochloride; paracetamol and pentazocine; paracetamol and mefenamic acid; and paracetamol, diclofenac potassium and caffeine anhydrous.
Besides these, few FDCs prohibited were also combinations of commonly used active pharmaceutical ingredients (API) having herbs such as ginkgo biloba as well as a mix of vitamins and enzymes.
This list of banned medicines also includes multi-enzyme complexes containing as many as 12-15 enzymes and over 20 formulations containing naphazoline, a decongestant commonly used in eye drops.
Banning The FDCs Involving Risk To Human Beings
This ban is definitely going to affect the brands which are sold by pharma giants such as Cipla, Dr Reddy’s laboratories, Sun Pharmaceuticals, Torrent, and Alkem, among others.
Under this notification, the government mentioned that they feel that these FDCs are “likely to involve risk to human beings whereas safer alternatives to the said drug are available”.
Further adding that two committees — including one under the Central Drugs Standard Control Organisation’s (CDSCO) Drugs Technical Advisory Board (DTAB) — examined the FDCs and found that “there is no therapeutic justification for the ingredients contained” in the combination drug while they may involve “risk to humans”.
The notification said, “Central Government hereby prohibits the listed FDCs’ manufacture for sale, sale and distribution for human use with immediate effect”, while exercising the power conferred by the section 26A of the Drugs and Cosmetics Act, 1940.
Most FDCs examined by the panels were found lacking in “therapeutic justification and were potentially harmful to patients” said Dr Nilima Kshirsagar, who has headed the CDSCO committees based on whose recommendations the government has affected bans on FDCs in the past.
Here’s the list of all the drugs banned.
