A parliamentary panel on heath found that pharma companies are advertising prescription drugs, which is not permitted in India. The Standing Committee also made a shocking revelation that the DCGI is favouring drug manufacturers by approving drugs without conducting mandatory clinical trials
A parliamentary panel which made a shocking revelation that on an average Drug Controller General of India (DGCI) is approving one drug every month without trials has also pointed out that pharmaceutical majors like Ranbaxy, Cipla, USV and Lundbeck are advertising prescription drugs, falling under Schedule H, which is not permitted in India.
The report tabled in the parliament on 8th May by the Standing Committee on Health and Family Welfare said that it has noticed the advertisements of prescription drugs such anti-depressant Deanxit of Lundbeck, USV's cholesterol lowering Coltro, and also ads of anti-epileptic agent C-Toin (USV), Desval (Ranbaxy) and Lametec DT (Cipla).
The committee, in its report, has recommended to the ministry (health and family welfare) to take action against these companies.
Pointing to the laxity in India's drugs regulation, the Standing Committee also made a shocking revelation that the DCGI is favouring drug manufacturers by approving drugs without conducting mandatory clinical trials.
Based on information provided by the ministry, the panel said that 31 new drugs were approved in the period between January 2008 and October 2010 without conducting clinical trials on Indian patients. It also said that, "There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO (Central Drugs Standard Control Organization) and some medical experts." The CDSCO is headed by DCGI.
The panel, which investigated and reviewed the drug regulation in India for 18 months, randomly picked up 42 medicines for scrutinising its approval status.
However the ministry could not provide any approval document on three drugs-pefloxacin, lomefloxacin and sparfloxacin, stating that the "files were non-traceable". According to the report, "Strangely, all these cases also happened to be controversial drugs; one was never marketed in the US, Canada, Britain, Australia and other countries which have well developed regulatory systems while the other two were discontinued later on. In India, all the three drugs are currently being sold."
On scrutinising 39 drugs, the Committee found that for 11 drugs, mandatory Phase III clinical trials were not conducted. These drugs includes Switzerland-based Novartis' Everolimus and Aliskiren; Cipla's Colistimethate and Pirfenidone, UCB's Buclizine and GlaxoSmithKline's Ambrisentan among others.
The report reveals that for two among these drugs, Sanofi's Dronedarone and
Novartis's and Aliskiren clinical trials were conducted on just 21 and 46 patients respectively as against the statutory requirement of at least 100 patients; for one drug Irsogladine (Macleods) trials were conducted at just two hospitals as against legal requirement of three to four sites.
The panel found that in case of Novartis' Everolimus, UCB's Buclizine, Eli Lilly's
Pemetexid and Theon's fixed dose combination of Pregabalin, no expert opinion was sought and they were approved by the non-medical staff of CDSCO. While in case of case of 25 drugs opinion of medically qualified experts was not obtained before approval.
According to the report of the total scunitized drugs, 13, like UCB's Buclizine for appetite stimulation, fixed dose combination of Tolperisone with Paracetamol (Themis), Nimesulide injection (Panacea), etc, do not have specific relevance to the medical needs of India. Sale of these drugs is banned in countries like the United States, Canada, Britain, etc
The panel also mentioned that in 14 out of 39 drugs, the number of experts consulted was generally three to four, though in isolated cases the number was more. Citing the example of the United States Food and Drug Administration (USFDA) which constituted a panel of 37 experts drawn from all over the country to review just the dose of the popular pain-killer paracetamol and also uploaded the expert opinion on its website, the report remarked that, "In India, every discussion and document is confidential away from public scrutiny. This matter needs to be reviewed to ensure safety of patients, fair play, transparency and accountability."