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Gujarat FDCA finds more than 22% drugs manufactured in HP substandard

Gireesh Babu, MumbaiFriday, November 28, 2008, 08:00 Hrs  [IST]

The tax holiday state of Himachal Pradesh tops the list of states that produce substandard drugs in the country. The Gujarat State Food and Drugs Control Administration (FDCA), in its sample testing during the last one year ending September, has found that more than 22 per cent of the drugs manufactured in Himachal Pradesh are substandard, which is double than any other state. According to the records of the Gujarat (FDCA), in its routine sample tests conducted in the state over a total 1794 samples in its drug testing laboratory, Baroda in the period from August 2007 to September 2008, it has found almost 22.35 per cent of the samples manufactured in Himachal Pradesh as substandard. Out of the total samples tested, 255 were manufactured in Himachal Pradesh and the laboratory reported failure of 57 samples from this, informed FDCA sources. "We have found that the presence of substandard drugs from the tax haven state is more than double of the total rate of substandard drugs from other parts of the country including Gujarat," said a higher official from FDCA. While the other parts of the country, on an average, has recorded around 8 to 10 per cent failure rate in sample testing, the rate goes up to more than 22 per cent in drugs from Himachal Pradesh alone. He added that the ratio was almost the same in the tests conducted in the previous year too. The administration is currently proceeding with actions against the manufacturers of these products. Further, sources added that the lab has also detected almost five products including some ointments manufactured in the northern state as spurious in nature. The FDCA is taking action against some three companies for manufacturing these spurious products. The products were found with lack of adequate quantity of active drug and not of standard quality packaging. As reported earlier, the Maharashtra State Food and Drug Administration (FDA), of late, has asked the Drug Controller General of India (DCGI) to take 'appropriate punitive action' against drug manufacturers whose products have repeatedly failed in the sample testing conducted by the FDA during the last three years. The regulatory officials from Gujarat said that the action taken by the drug control office of Himachal Pradesh, of suspending product license alone for malpractices, is not effective to curtail the prevalence of substandard drugs. Even as the product license is cancelled for a particular product, the company can manufacture other lines of products in the same plant. The drug control authority should suspend the manufacturing license of the plant for a fixed period, similar to the procedure followed by states including Gujarat, to curb the problem of substandard drugs, they added.

 
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