Dabur given go-ahead to market birth defect-causing drug
one would think that if lethal effects of a drug were proven, the pharmaceutical world would give it a quiet burial. Surprisingly, this does not hold true for thalidomide -- a drug that was banned world over in 1962 after discovering that it led to birth defects such as mental retardation and deformed limbs. Recently, Dabur India was granted rights to manufacture and market the controversial drug for treating cancer and leprosy lesions.
Pharmaceutical companies say that phasing-out thalidomide is not justified considering its usefulness for treating lesions in leprosy and curing patients suffering from painful mouth and genital ulcers. In addition, the drug also stops supply of blood to cancerous tumours, thereby, halting their growth. The companies assert that with proper vigilance, the drug's use would do more good than harm. Pharmacovigilance as it is called, is however, rarely applied in India since most of the drugs are manufactured or marketed here nearly four years after they have been introduced, approved and successfully marketed in other countries. Experts question Dabur's ability to monitor the misuse of the drug. With vast majority of Indian population being illiterate, how is Dabur going to ensure the right usage? This is particularly alarming considering that when contacted, the assistant drug controller Ravi Kant was unaware about the granting of the license.
Dabur officials are, however, confident. "Precautions would be taken. For one, the drug will be marketed by dealers who would maintain records about doctors prescribing it as well as the patients taking it," says S Ganguly, senior research scientist at Dabur. Despite these assurances, experts emphasise on the need for a surveillance system to ensure safe use of the drug. "It is important for the clinicians and patients to be on the look-out for unexpected effects of drugs administered," says M D Nair, a pharmaceutical industry consultant based in Chennai.
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