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No Checks on Quality Of GMC Pharmacy Drugs

The Comptroller and Auditor General (CAG) report for 2014-15 tabled on the floor of the state Assembly has pointed out that the state Food and Drug Administration (FDA) was carrying out testing of drugs and chemicals from the Goa Medical College pharmacy “only occasionally and not regularly,” allowing scope for selling of untested and substandard medicines to the patients. A random checking of the drugs lifted from the GMC by the FDA over the last five years has revealed that around 10 per cent of the drugs procured by the apex health institution of the state were substandard. The sample collection by the FDA from the GMC, which procures around 900 drugs, is too small and there is possibility that more substandard drugs were dispensed to the patients seeking treatment at the GMC. The government should take steps to find out who were at fault for supply of substandard drugs. Given the fact that any lapse in ensuring supply of quality drugs could lead to serious health concerns by a government department the state authorities ought to take immediate steps to ensure that there was a system in place to check and ensure that only those drugs that meet the set specifications were procured by the government or private hospitals.

Though the FDA is supposed to be the authority for analyzing drug samples in the state not only from the government hospitals but also from the private hospitals and 650-odd medical stores, it has its limitations in staff and machinery that can test between 1,000 and 1,200 drug samples in all. If the FDA puts its manpower and machinery to test samples of each batch of medicine supplied to GMC then around 80 per cent of its capacity in testing would be consumed for one institution only and there is possibility of unscrupulous elements in the private sector playing with the health of the people by selling substandard drugs. Besides, since GMC is a government agency, technically there are checks and balances in procuring the drugs which are specified in the tender documents. In accordance with tender documents every supplier of drugs has to ensure that a certificate of analysis was handed over to the GMC for each batch of drugs supplied, together with a certificate from a government-approved independent laboratory for authenticity of the drugs. There is no role for the FDA in routinely checking each and every drug from the GMC according to the tender documents.

That quite a few drugs were substandard shows the GMC allowed their procurement without any check. The GMC did not make the FDA a party to tendering process. Since the FDA is understaffed and has limited machinery to check around 50,000 drugs sold in the state, the government should support its expansion in order to make it accountable for guaranteeing quality of all the drugs sold in the state. Besides, as it takes a long time to analyse drugs the government should also ensure that a state of the art technology, which facilitates faster analysis of drugs, was made available to the FDA. As it is a question of health risks to people the government should be liberal in allocating funds for helping FDA acquire manpower and top-notch technologies to achieve that goal.

With the CAG pointing out a major deficiency in guaranteeing supply of quality drugs in the GMC, the onus is on the state authorities to make necessary provisions in the tender documents incorporating a clear-cut role for the FDA. The state should also order a probe to check the lapses in procuring the substandard drugs. As the reports of analyses of drugs were received between 22 and 176 days from the date of their collection by the FDA officials there is need to find out whether there was any harmful effect on those who were dispensed these medicines. It would be in the interest of all that recurrence of such lapses was prevented in the future by having checks and balances in place with the officials in-charge of procuring medicines in GMC being charged to ensure quality. Besides, the authorities should also probe whether the necessary certificates were handed over to the GMC authorities by the suppliers of the substandard drugs as specified in the tendering documents or not. If the certificates were not given by the suppliers the question how the drugs were allowed to be supplied should also be probed and accountability fixed. It is time that health risks to people arising from substandard drugs were not ignored by the authorities. The government must put in place a foolproof mechanism to guarantee safe quality of medicines.

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