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Have your drugs passed clinical trials for sure?

Is the government putting the life of Indian patients at risk?

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Is the government putting the life of Indian patients at risk? The standing committee on health and family welfare has found that the mandatory norms of Phase III clinical trials were not being followed strictly in India and in many cases approval for drugs was given by non-medical staff of the Central Drugs Standard Control Organisation.

According to information given by the health ministry to the committee, a total of 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients. Thus, there was no evidence to show that these drugs were effective and safe.

The panel headed by Congress MP Jyoti Mirdha lashed out the ministry and its statutory bodies like CDSCO and Drugs Controller General of India (DCGI) for putting patients at risk by not completing proper trials. It claimed irregular approvals spare the drugs producers the cost and efforts but put patients at risk while hinting at a nexus between drug manufacturers and experts whose opinion matters in the decision making process of CDSCO.

On an average, the DCGI is approving one drug every month without trials, the committee observed.

Out of the 42 drugs picked up randomly by the committee, phase III clinical trials mandated by rules for 11 drugs were not conducted These drugs are 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, Methylocobolamine, Alpha Lipoic Acid, Pyridoxine and Folic Acid (Theon).

Worst is that 33% drugs, like Nimsulide injection, scrutinised were banned in USA, Australia, etc. But they are sold openly in India. 

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