Central government immediately banned these 16 combination medicines, are you also using them?

New Delhi :-‘The Union Ministry of Health and Family Welfare has banned the manufacture, sale and distribution of 16 fixed dose combination (FDC) medicines with immediate effect. According to the government, the review investigation by the Expert Committee, Drugs Technical Advisory Board (DTAB) and its sub-committee found that sufficient scientific and medical evidence was not available to justify the combination of these drugs. The government acknowledged that the use of these medicines may pose a risk to patients, while safer alternatives are already available, hence, based on the recommendations of expert committees, the manufacture, sale and distribution of these medicines has been banned under Section 26A of the Drugs and Cosmetics Act, 1940.
Have a look at the formula of these medicines

The banned FDCs belong to various categories, including dermatological preparations, analgesic and antispasmodic drugs and antibiotic-based formulations. Many of these contain combinations that include aloe vera extract, antibiotics along with enzymes or unnecessary multi-drug combinations.
Ban on these fixed dose combination medicines

1- Acetyl Salicylic Acid + Ethoheptazine (Acetyl Salicylic Acid + Ethoheptazine)
2- Jojoba Oil + Wheat Germ Oil + Tea Tree Oil (Aloe Vera + Jojoba Oil + Wheat Germ Oil + Tea Tree Oil)
3- Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes (Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes)
4- Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide (Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide)
5- Amoxicillin + Serratiopeptidase (Amoxicillin + Serratiopeptidase)
6- Aloe Extract + Allantoin + Alpha Tocopherol Acetate + D-Panthenol + Vitamin A
7- Aloe Extract + Vitamin E + Dimethicone + Glycerine
8-Aloe Vera + Jojoba Oil + Vitamin E
9- Aloe Vera + Orange Oil
10- Aloe Vera + Vitamin E + Herbal Preparation
11- Dicyclomine + Paracetamol + Clidinium Bromide
12- Paracetamol + Lignocaine
13- Gliclazide + Chromium Picolinate
14- Amoxicillin + Cloxacillin + Lactic Acid Bacillus + Serratiopeptidase (Amoxicillin + Cloxacillin+ Lactic Acid Bacillus+ Serratiopeptidase)
15- Cefadroxyl + Probenecid
16- Cefuroxime + Serratiopeptidase
The ministry stressed that this action has been taken to promote the correct use of medicines. Even before this, many inappropriate FDCs have been banned after scientific review. Under the order, manufacturers, importers, distributors and other stakeholders of these drugs have been advised to immediately comply with the notifications.

Objection to the combination with amoxicillin-

The Central Government’s expert committee found that there is not enough clinical evidence for the simultaneous use of amoxicillin and Serratiopeptidase. This combination does not conform to standard treatment guidelines and there is not enough scientific evidence available for its benefits. Therefore it was considered illogical.

In the case of Dicyclomine + Paracetamol + Clidinium Bromide, Chlordiazepoxide, Amoxicillin, the committee said that since both Dicyclomine and Clidinium have similar effects, there is no solid justification for combining them. Apart from this, many aloe vera based formulations for skin and cosmetic purposes were also not considered medically appropriate.

What will change after the order?

After the government’s order, now pharmaceutical companies will have to stop the production of these products. At the same time, doctors will have to prescribe safe and scientifically proven FDC medicines in their place. According to officials, this will help in providing more safe and effective treatment to patients.

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