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New Delhi: In its monthly alert for the month of August, the countrys apex drug regulator said it found 59 medicines, some of them well-known and marketed by top pharma companies, were found substandard or fake.Against the backdrop of flak over supply of drugs and cough syrupsassociated with serious adverse events including deathsto other nations, this, understandably, triggered outrage...
But those batting for patients rights and better quality of drugs point out that India has larger problems to deal with including the lack of effective mechanisms to guarantee a national recall of such drugs...
A close look at government data showing the proportion of not of standard quality (NSQ) or counterfeit drugs reaching the Indian market reveals that this number hovers between 3.2 to 3.5 percent...
Another major concern, said Malini Aisola, convenor of the patient rights group All India Drug Action Network (AIDAN), is that CDSCO drug alerts do not name the marketing companies of drugs found substandard even though liability of drug recall rests with both manufacturers and marketers...
Moreover, statistics could be deceptive because samples tested for quality largely do not include FDCs (fixed dose combination drugs) which comprise over 40 percent of drugs sold in India as there are no norms in place to test their quality, Aisola said.. FDCs contain two or more drugs in a single pharmaceutical form and many of these combination medicines available in India lack approval from the central regulator CDSCO and have been approved for manufacturing by states without showing adequate proof of safety and efficacy...
