The All India Drugs Control Officers Confederation (AIDCOC) has demanded that the Union health ministry suspend the approval granted to 33 drugs for sale in India with immediate effect, as the approval was given without conducting the required clinical trials.
The Parliamentary Standing Committee made the following onservations on some medicines available in India :
* For 11 drugs, the mandated Phase III clinical trials were not conducted. Everolimus (Novartis), Colistimethate (Cipla), Exemestane (Pharmacia), Buclizine (UCB), Pemetrexid (Eli Lilly), Aliskiren (Novartis), Pentosan (West Coast), Ambrisentan (GlaxoSmithKline), Ademetionine (Akums), Pirfenidone (Cipla), and FDC of Pregabalin, ethylcobolamine, Alpha Lipoic Acid, Pyridoxine & Folic Acid (Theon);
* Clinical trials were conducted for Dronedarone (Sanofi) and Aliskiran (Novartis) on just 21 and 46 patients respectively as against the statutory requirement of at least 100 patients.
* In case of Irsogladine (Macleods), trials were conducted at just two hospitals as against legal requirement of 3-4 sites
* Mandatory phase III clinical trials were not conducted and the opinion of experts was not sought.Everolimus (Novartis);Buclizine (UCB); Pemetexid (Eli Lilly)FDC (Pregabalin)
* 13 drugs did not have permission for sale in any developed countries. None of these drugs have any special relevance to India. Buclizine (UCB); Nimesulide (Panacea); Doxofylline (Mars); Pregabalin (Theon); Nimesulide with levocetirizine (Panacea); Tolperisone with Paracetamol (Themis); Etodolac with 28 Paracetamol (FDC); Aceclofenac with Thiocolchicoside (Ravenbhel); Ofloxacin with Ornidazole (Venus)Aceclofenac with Drotaverine (Themis); Glucosamine with Ibuprofen (Centaur)Diclofenac with Serratiopeptidase (Emcure)Gemifloxacin with Ambroxol (Hetero)
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