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Irrational combinations, Rajasthan DC seeks DCGI's response
Joe C Mathew, New Delhi | Tuesday, September 28, 2004, 08:00 Hrs  [IST]

The Rajasthan State Drugs Control Department has taken serious note of the list of "irrational combinations" prepared by a leading medical journal and sought advice from the Drugs Controller General of India (DCGI) on how to put an end to the "alleged" presence of all these "dubious" fixed-dose combinations and drugs discarded or not used in the developed world.

In a letter to the DCGI with copies to all state drug controllers as well as formulation committees and the state drug traders association, the state drug controller wanted to know if there is DCGI approval for all the drugs that are mentioned in the list.

Directly referring to the list published by Monthly Index of Medical Specialities (MIMS), the drug controller explained that "as a practice, the applicants while seeking approval / product permission, quote the reference of similar / parallel products being manufactured and traded in the country, leaving hardly any scope for a state licensing authority to think twice before releasing approvals". Hence he wanted the DCGI to issue instruction about the locustandi and instruction for such combinations.

The combinations referred by the state DC are:
ALPRAZOLAM + SERTRALINE
ALPRAZOLAM + IMIPRAMINE
ALPRAZOLAM + FLUOEXETINE
ALPRAZOLAM + MELATONIN
IMIPRAMINE + DIAZEPAM
RISPERIDONE + TRIHEXYPHENIDYL
NORFLOXACIN + TINIDAZOLE
NORFLOXACIN + TINIDAZOLE + DICYCLOMINE
NORFLOXACIN + TINIDAZOLE + LOPERAMIDE
NORFLOXACIN +  METRONIDAZOLE
NORFLOXACIN + ORNIDAZOLE
CIPROFLOXACIN + TINIDAZOLE
CIPROFLOXACIN + METRONIDAZOLE
OFLOXACIN + TINIDAZOLE
OFLOXACIN + METRONIDAZOLE
OFLOXACIN + ORNIDAZOLE
GATIFLOXACIN + ORNIDAZOLE
FLUCONAZOLE + TINIDAZOLE
DOXYCYCLINE + TINIDAZOLE
TETRACYCLINE + METRONIDAZOLE
TRAMADOL + CHLORZOXAZONE
MEFENAMIC ACID + DROTAVERINE
MEFENAMIC ACID + TIZANIDINE
NIMESULIDE + CAFFEINE
NIMESULIDE + DROTAVERINE
NIMESULIDE + PARACETAMOL
NIMESULIDE + DICLOFENAC
NIMESULIDE + DICYCLOMINE
NIMESULIDE + CHLORZOXAZONE
NIMESULIDE + METHOCARBAMOL
NIMESULIDE + CAMYLOFIN
NIMESULIDE + SERRATIOPEPTIDASE
NIMESULIDE + TIZANIDINE
NIMESULIDE + PARACETAMOL + CHLORZOXAZONE
NIMESULIDE + TIZANIDINE + PARACETAMOL
NIMESULIDE + CETIRIZINE + PSUEDOEPHEDRINE
ACECLOFENAC + PARACETAMOL
TIZANIDINE + PARACETAMOL
ROFECOXIB + PARACETAMOL
ROFECOXIB + TIZANIDINE
VALDECOXIB + TIZANIDINE
IBUPROFEN + TIZANIDINE
DICLOFENAC + TIZANIDINE
DICLOFENAC + FAMOTIDINE
DICLOFENAC + PARACETAMOL + TIZANIDINE
DICLOFENAC + SERRATIOPEPTIDASE
DICLOFENAC + PARACETAMOL + SERRATIOPEPTIDASE
DICLOFENAC + FENPIVERINIUM + PITOFENONE
IBUPROFEN + PARACETAMOL + MAGNESIUM TRISILICATE
RANITIDINE + DICYCLOMINE
SUCRALFATE + OXETHAZINE
CISAPRIDE + SIMETHICONE
CISAPRIDE + OMEPRAZOLE
MOSAPRIDE + METHYLPOLYSILOXANE
MOSAPRIDE + PANTOPRAZOLE
MAGALDRATE + SIMETHICONE + OXETHAZINE + DICYCLOMINE
DIAZEPAM + DRIED ALUMINIUM HYDROX. GEL + ALUMINIUM GLYCINATE + OXYPHENONIUM
DIAZEPAM + DRIED ALUM. HYDROX. GEL + MAGNESIUM TRISILICATE + DIMETHYLPOLYSILOXANE
DIAZEPAM + MAGALDRATE + OXYPHENONIUM
DIAZEPAM + PROPANTHELINE + DIHYDROXY. ALUM.
PIPENZOLATE + PHENOBARBITONE
AMOXYCILLIN + CLOXACILLIN+ LACTOBACILLUS + SERRATIOPEPTIDASE
AMOXYCILLIN + SERRATIOPEPTIDASE
AMOXYCILLIN + PROBENECID + TINIDAZOLE
CEFADROXIL + PROBENECID
ROXITHROMYCIN + SERRATIOPEPTIDASE
CEFIXIME + AMBROXOL+ LACTOBACILLUS
ROXITHROMYCIN + AMBROXOL
CIPROFLOXACIN + AMBROXOL
GATIFLOXACIN + AMBROXOL
CEFOPERAZONE + SULBACTUM
ENALAPRIL + LOSARTAN
ATENOLOL + LOSARTAN
AMLODIPINE + LOSARTAN
AMLODIPINE + LISINOPRIL
AMLODIPINE + ENALAPRIL
AMLODIPINE + RAMIPRIL
AMLODIPINE + ATORVASTATIN
ATENOLOL + ALPRAZOLAM
PROPRANOLOL + ALPRAZOLAM
PROPRANOLOL + DIAZEPAM
CINNARIZINE + DOMPERIDONE
DOMPERIDONE + RANITIDINE
ONDANSETRON + RANITIDINE
ONDANSETRON + LANSOPRAZOLE
DOMPERIDONE + OMEPRAZOLE
DOMPERIDONE + FAMOTIDINE
DOMPERIDONE + PANTOPRAZOLE
DOMPERIDONE + LANSOPRAZOLE
MEBENDAZOLE + PYRANTEL
MEBENDAZOLE + LEVAMISOLE
SIMVASTATIN + NICOTINIC ACID
ATORVASTATIN + NIACIN
LORATADINE + AMBROXOL
CETIRIZINE + AMBROXOL
CETIRIZINE + DEXTROMETHORPHAN + PHENYLPROPANOLAMINE (PPA)
CETIRIZINE + PARACETAMOL + PHENYLPROPANOLAMINE (PPA)
CLOPIDOGREL + ASPIRIN
GLIMEPIRIDE + PIOGLITAZONE
MONTELUKAST + BAMBUTEROL
TRANEXAMIC ACID + ETHAMSYLATE
TRANEXAMIC ACID + MEFENAMIC ACID
TAMSULOSIN + FINASTERIDE

According to editor, MIMS, almost all these combinations are marketed without DCGI approval in the country. "These partial, cumulative list of dubious fixed-dose combinations (FDCs) are available in India but not approved in any developed country. Many of these combinations are not approved by the Drugs Controller General, India and hence illegal", he explained.

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