Certain fixed-dose combination drugs which were in use in the Indian market has now been banned. If you are a doctor or a patient, you need to be aware of this list of drugs, which are banned.

Update: 20/09/2018

Saridon ban has been lifted.No other change is currently known.

FDC   Drugs banned by the Government of India include:

Ornidazole Ofloxacin

Saridon

Taxim AZ cefixime with Azithromycin

acecolofenac (SR) + Paracetamol

Aceclofenac + Paracetamol + Famotidine

Aceclofenac + Paracetamol + Rabeprazole

Ambroxol + Levocetirizine + Phenylephrine + Guaiphenesin + Menthol

Amoxicillin + Dicloxacillin

Azithromycin + Ofloxacin

Becloemthasone + Clotrimazole + Chloramphenicol + Gentamycin + Lignocaine Ear drops

Beclomethasone + Clotimazole + Neomycin + lodochlorohydroxyquinone

Beclomethasone + Clotrimazole + Gentamicin + lodochlorhydroxyquinoline

Clotrimazole + Beclomethasone + Ofloxacin + Lignocaine

Neomycin + Doxycycline

Nimesulide + Certirizine + Phenylephrine

Nimesulide + Cetrizine + Caffeine

Nimesulide + Diclofenac706234Nimesulide + Dicyclomine

Nimesulide + Loratadine + Phenylephrine + Ambroxol

Nimesulide + Paracetamol + Cetirizine + Phenylephrine

Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine

Nimesulide + paracetamol Injection

Nimesulide + Paracetamol Suspension

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How is a New Drug approved in India?

New Drug Approval the steps

• At the Central level DCGI, under Ministry of Health and Family Welfare approves drug or Medical device for marketing.
• But the manufacturing license is approved at State level by State drug control authorities.
• Pharmaceutical companies often market a drug under their label, while manufacturing is done by another company.
• Monitoring is done by state agencies coordinating with Central departments.

While most doctors avoid fixed-dose combination, drugs this list of banned drugs will prevent over the counter unscrupulous selling of many medicines, which are often bought and sold without a doctors prescription.

What are FDC drugs?

FDC or fixed-dose combination drugs have two or more active components.

What is the worry with FDC drugs?

• The irrational use is giving rise to antibiotic resistance against infectious diseases.
• Unnecessary extra drug intake causing side effects.
• Inadequate dosage of drugs in some cases.
• Prescriptions by unscrupulous Quacks, who lack knowledge about responsible drug therapy. Quacks are often unable to know the exact cause, effect relation of diseases and give combination drugs hoping one would work.

When it’s a combination drug, since its given together in a molecule, the pharmacological effect of it may be changed from what is known about each of them individually. In case of adverse reactions, its difficult to identify culprits

In the USA there are about 500 FDC drugs. In India, this number is more than 2000!

Going forward the responsibility lies with

• The Government
• Pharmaceutical Companies
• Doctors and
• People for the responsible use of medicines

Always visit your doctor or nearest Government healthcentre in case you are ill. Depending on OTC(over the counter) drugs prescribed by an unqualified person, puts you at unnecessary health risks.

Reference:

https://am.asco.org/daily-news/drug-approval-process-india

https://www.ndtv.com/india-news/fdc-drugs-328-fixed-dose-combination-drugs-banned-by-health-ministry-1915839

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Disclaimer:This is meant for Public knowledge and awareness.Kindly consult your doctor before using or stopping any medicines