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
Get the full list by signing up here
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
I am taking part in MyFriendAlexa campaign by Blogchatter.
Disclaimer:This is meant for Public knowledge and awareness.Kindly consult your doctor before using or stopping any medicines