The Central government has admitted the presence of a large number of unapproved nimesulide formulations in the country. In an affidavit recently submitted before the High Court of Delhi, the centre said that most of these drugs were approved by the state drug control authorities and cannot, prima faci, called "illegal drugs". The reason for the state level approval for new drugs, is on account of certain anomalies existing in the Drugs and Cosmetics Rules.
The centre's admission came during a recent hearing of an SLP, which sought the withdrawal of nimesulide formulations from Indian markets. The Social Jurists, which had filed the SLP, had pointed out the presence of more than 200 nimesulide based formulations in the country. The petitioners list included 70 nimesulide 50 mg / 5ml suspension formulations and 130 fixed dose combinations.
The suspension formulations are Amlid (Macmillion), Anafebrin (Themis), Auronim (Aurobindo Pharma), Bionims (Indkus), Delite (Deccan), Denim (Dew Drops), Doloid (Ethypharm LL), Dolonim (BIPL), Emsulide (Emcure), Flexulid (Wander), Mangolide (DWD), Maxiflam (Karnataka Antibiotics), Momelid (Nestor), N-Side (CFL Pharmaceuticals), Needfast (Acme Pharmaceuticals), Nefter (NEISS Lab), Neimeriv (East African), Nemon (Chemo Drugs), Nemunac (Lancer Health Care), Neosulide (Aaron Pharma), Nicalid (Replica Remedies), Nil-Rich (Richie Labs), Nilide (New Gen), Nim (Weishorn), Nimact (Indu Drugs), Nimbus (Moraceae Lab), Nimegesic (Alembic), Niment (Ascent Lab), Nimeril (Albert David), Nimexin (Biocin Healthcare), Nimez (Zota Pharmaceuticals), Nimfast (Cadila), Nimi-Rapitab (Shreya), Nimind (Indoco Remedies), Nimobid (MAPRA), Nimodol (Aristo Pharmaceuticals), Nimogil (V S Healthcare), Nimowen (Wens Pharma), Nimuflex (Sarabhai), Nimze ( Franklin Labs), Nisul-100 (Arbro), Nixia (Wander), Nobel (Mankind), Novogesic ( Glenmark), Nugesic (Unimarck Pharma), Numel (Elysium Pharma), Olnim (Olcare Lab), Ornim (Dynamic), Orthobid (Nicholas Piramal), Orthogesic (Litaka Pharma), Paralide (Lenit Pharma), Pfine (Bupa Pharma), Pirodol (Menarini Raunaq), Pronim (Unichem Pharma), Pyranim (Saga Labs), Redfast (Marc India), Relexulide (Maitri H Care), Samulid (Samson), Soonil (Wallace Pharma), Solide (Brawn Pharma), Sulid (Shinto Organics), Toli (Cosmic Pharma), Zega (Sun Pharma), Zolandin (SPPL) and Zydol (Jenburkt).
The fixed dose combinations of Nimesulide being marketed without DCI approval are:
Nimesulide + Paracetamol (50 mg)
Acilid Plus (allure Remedies), Artifen (Agkowmed), Baselide-Plus (Ultramark), Bestogesic Plus (Bestochem), Deemulid-P (Deetech Pharma), Diplonim-P (Pharmatech), Dolamide (Ranbaxy), Doloflam Plus (Vilco), Dolonim-P (BIPL), Dolprin (Relish), Emsulide-P (Emcure), Emulide-P (Zinet), Gesnim-P (Aarpik Pharma), Manlide-P (Shalman), Minisule Plus (Manish Pharma), Nelsid Plus (Ind-Swift), Nemeriv-P (East African), Nepar (Rusan Healthcare), Niap (American Remedies), Nicalid-P (Replica Remedies), Nide-P (Nectar Pharma), Nimat Plus (Atoz Pharma), Nimeb-P (Taurus Labs), Nimeson-P (Unison Pharma), Nimetec Plus (Talent Labs), Nimex Plus (Lanark Lab), Nimica Plus (IPCA), Nimil Plus (Shaimil), Nimiz Plus (Zota), Nimool-P (Ontario), Nimsaid-P (Medley), Nimuzen Plus (Zenith), Nimvid-P (Vivid Labs), Nipar (Axon HC), Niq-P (Que Pharma), Nobel Plus (Mankind Pharma), Nock 2 (Wander), Noflam-P (Euphoric), N.S. Plus (Phoebus), Pain Lock (VIP Pharma), Paranim (Allianz HC), Parashoot (National Chemical & Pharma), Parazolandin (Sarabhai Piramal), Remudol (Recon), Salapain (Kee Pharma), Solid-P (Brawn), Sulid-P (Shinto Organics), Sumo (Alkem), Ultramin (BIPL) and Zimulide-P (Zinet).
Nimesulide + Paracetamol + Tizanidine (2)
Bestogesic MR (Bestochem) and Trizone Forte (Zee Lab)
Nimesulide + Paracetamol + Chlorzoxazone (3)
Nimpac (Sysmed), Nimzox-P (Rapross Pharma) and Sies-NMR (Siesta Pharma)
Nimesulide + Diclofenac (2)
Emsulide-Fen (Emcure) and Nidegesic (VIP Pharma)
Nimesulide + Dicyclomine (10)
Avospas (Shreeyam Healthcare), Comspa (Comed), Cyclolide (Shalman), Lidspas (Axar Pharma), Menark (Sysmed Labs Pvt Ltd), Nidaspas (VIP Pharma), Nimspa (Obsurge), Nimuspas (Stedman Pharma), Nise Spas DS (Dr Reddys) and Spasfree (Grandix).
Nimesulide + Chlorzoxazone (7)
Nam Plus (Lincoln), Nim-MR (Varun Continental), Nimozox (Wens Pharma), Nimuzox (Stedman Pharma), Nimzox (Rapross Pharma), Nizox (Grandix) and Nucil (Adley Lab).
Nimesulide + Tizanidine (29)
Avolide T (Shreeyam Healthcare), Deemulid-T (Detech Pharma), Dolonim MR (BIPL). Itzgon (Kee Pharma), Moztin (East African), Nesta (Prochem), Nimcom-MR (Comed Chemical), Niment MR (Ascent Lab), Nimetiz (Ajanta), Nimstal Plus (Indchemie), Nimuben TZ (Bantom Lab), Nimulid-MR (Panacea), Nimzone-MR (Woodrock), Nipace-MR (Femcare), Nixia MR (Wander), Nobel MR (Mankind), Oxin-MR (Synokem), Siena (Siesta), Teknoflex (DWD), Tiza-N (Mediwin), Tizanim (Alkhem), Tized-M (Talent India), Tizilex (Profic Organic), Tizpa-N (Blue Cross), Tizu (Indoco), Tizulid (BIPL). Zelid-TZ (Zee Lab), Zenim MR (Universal Medicare) and Zulu (Unichem).
Nimesulide + Camylofin (1)
Anafortan-N (Khandelwal).
Nimesulide + Serratiopeptidase (23)
Emanzen-N (Emcure), Kineto-N (Systopic), Lytic-N (Wens Pharma), Maxiflam (Karnataka Antibiotics), Nelsid-S (Ind-Swift), Nimdase (Obsurge), Nimool-SP (Ontario), Nimsaid-S (Medley), Nimseer (Arvind Remedies), Nimudaz (Sresan Pharma), Nimulase (TTK), Nimulid-SP (Panacea), Nimvon-S (Ajanta), Optase-NH (Osper Pharma), Oxin Plus (Synokem), Seranavi (Speciality Meditech), Seratodase-N (Marc Lab), Seretaur-N 10 (Taurus Labs), Sernium (Sysmed), Serulid (Radico Remedies), Stalwar-N (Profic), Orthozen (litika Pharma) and Maxiflam-SP (KAPL)
Nimesulide + Methocarbamol (1)
Robilid (Khandelwal)
Nimesulide + Droaverine (1)
Nobel Spas (Mankind)
Nimesulide + Cetrizine + Pseudoephedrine (1)
Nam-Cold (Lincoln)