With 10 percent of 3.63 trillion medicines popped worldwide in 2015, India is the world’s third-largest medicine market. It stands to scientific reason that these drugs will have side effects.
Posted in FEATURES
Tagged ADR, Adverse Drug Reactions, Claudio Naranjo, Dr Atul Gogia, Dr Kunal Saha, Dr Reddy's Laboratories, Dr Y K Gupta, Drug Monitoring, Drug Side-Effects, Medical Negligence, Merck, Metformin, Naranjo Scale, Nimesulide, Nimulid, Panacea Biotech, Pazopanib, Pharmacovigilance, Rofecoxib, Sunitinib Malate, Uppsala Monitoring Centre, VigiBase, World Health Organisation
The problem of irregularities in drug trials or approval appears to be partly because of the fundamental flaw in the policies of the CDSCO. Unlike its western counterparts, it appears to be totally oriented towards promoting the interests of the drug firms rather than the patients/public.
Posted in OPINIONS
Tagged CDSCO, Critical Review, DCGI, Dr S K Joshi, Drug Trials, Glaxo, GSK, Health Fraud, List of Essential Medicines, MCI, MHRA, Mission Statement, Nimesulide, Parliamentary Committee on Health, Pharma Frauds, TGA, Themis Medicare, USFDA
New Delhi: The health ministry on Thursday said it has “already taken several steps” to plug loopholes in the Central Drugs Standards Control Organization (CDSCO), which has been pulled up by a parliamentary panel for allowing at least 33 drugs to be sold in India without proper trials.
Posted in NEWS
Tagged Ademetionine, AIIMS, Buclizine, CDSCO, Clevusine, Clinical Trials, DCGI, Drug Trials, Health Ministry, Irregularities, KBN Medical College, Lomefloxacin, Nimesulide, Panacea, Parliamentary Standing Committee on Health, Pefloxacin, Phamasset, Pregabalin, RG Kar Medical College, Sparfloxacin
New Delhi: Huge irregularities have surfaced in the functioning of Central Drugs Standards Control Organisation (CDSCO), with a parliamentary panel pointing out that at least 33 drugs have been allowed to be sold in India without proper trials.
Posted in NEWS
Tagged AIIMS, Buclizine, CDSCO, Clevusine, DCGI, Irregularities. Drug Trials, KBN Medical College, Lomefloxacin, Nimesulide, Ofloxacin, Ornidazole, Panacea, Parliamentary Standing Committee, Pefloxacin, Phamasset, Pregabalin, RG Kar Medical College, Sparfloxacin
New Delhi: A report by the parliamentary standing committee for health and family welfare, which looked at the functioning of the Central Drugs Standard Control Organization (CDSCO), reveals that 33 new medicines were approved by the country’s highest office on drugs between January 2008 and October 2010, without the medicines undergoing human trials.
Posted in NEWS, Pharmaceuticals
Tagged Ademetionine, Akums, Alimta, Aliskiran, Aliskiren, Alpha Lipoic Acid, Ambrisentan, Bird Flu, Buclizine, CDSCO, Centaur, Cipla, Clinical Trials, Colistimethate, Cubicin, Daptomycin, DCGI, Doxofylline, Dronedarone, Drug Trials, Eli Lilly, Emcure, Everolimus, Exemestane, FDC of Aceclofenac with Drotaverine, FDC of Aceclofenac with Thiocolchicoside, FDC of Diclofenac with Serratiopeptidase, FDC of Etodolac with 28 Paracetamol, FDC of Gemifloxacin with Ambroxol, FDC of Glucosamine with Ibuprofen, FDC of Nimesulide with Levocetirizine, FDC of Ofloxacin with Ornidazole, FDC of Pregabalin, FDC of Pregabalin with other agents, FDC of Tolperisone with Paracetamol, Folic Acid, GlaxoSmithKline, GSK, Hetero, Irsogladine, Isentress, Macleods, MARS, Merck Sharp Dohme, Methylcobolamine, Nimesulide, Novartis, Panacea, Paracetamol, Parliamentary Standing Committee on Health, Pemetexid, Pemetrexed, Pemetrexid, Pentosan, Pharmacia, Phase III Clinical Trials, Pirfenidone, Public Interest, Pyridoxine, Raltegravir, Ravenbhel, Report on the Functioning of CDSCO, SAARS, Sanofi, Swine Flu, Themis, Theon, UCB, USFDA, Venus, West Coast
New Delhi: The Drug Controller General of India (DCGI) has asked the manufacturers of Nimesulide to add ‘box warning’ on its label, suggesting that its use to be restricted to 10 days and if longer clinical use is necessary then liver function test should be assessed periodically.
Posted in NEWS
Tagged DCGI, Nimesulide
Madras High Court has revoked a ban on manufacture and sale of paediatric drugs nimesulide and phenylpropanolamine (PPA). Early this year, the union health ministry had banned sale of anti-inflammatory drug nimesulide for use in children below 12 years of age and decongestant formulation PPA used in cough syrups citing their adverse impacts on human health, including liver toxicity.