HYDERABAD: At least 11 generic drugs, including painkillers, antibiotics, and cough syrups in use in Telangana were found to be ‘not of standard quality’ (NSQ) by the Union health ministry’s Central Drugs Standard Control Organisation (CDSCO) during its monthly inspections in February.
Additionally, seven of them were also labelled ‘misbranded’ — carrying false information. The list of NSQ drugs include: Amrox-LS syrup (used for cough), Aceglo tablets (fever and body pain), Moovrun (painkiller), Rabisap (antacid), and Cefixime dispersible (bronchitis and other infections). Each of them are priced between 10 and 60 per unit.
According to officials, a drug is branded NSQ if it fails to meet the regulations set by the Drugs and Cosmetics Act. This can be caused due to poor manufacturing, contamination, and stability issues leading to loss of potency of the drug over time, among other factors. The central body’s findings have led to concern among Telangana’s medical fraternity, given the large-scale consumption of these drugs.
NSQ drugs can have impact on vital organs
Consumption of NSQ drugs can lead to headache, nausea, and vomiting among users. In some cases, it can also have a major impact on a person’s vital organs and even result in death,” said a city-based neurologist, Dr Sudhir Kumar. He added: “Use of such drugs can also hit a family’s finances with prolonged illness forcing hospitalisation.”
While calling for strict action against such manufacturers, doctors said it was crucial for pharmacies and hospitals to keep a check on their sale. V B Kamalasan Reddy, director general of Telangana Drugs Control Administration (TGDCA), said the 11 drug samples failed in the “assay, dissolution, and description” tests which may render the medicines “ineffective in treating diseases”.”We will initiate prosecution against the manufacturing units,” the DCA chief added. According to him, while some of these drugs are sourced from local manufacturers, many are supplied to Telangana by other states.
‘Drug resistance can occur’
Reiterating the side effects, Dr G Srinivas, a clinical pharmacologist, said how use of NSQ or misbranded medicines can lead to drug resistance among patients making future treatment less effective. He urged the DCA to take up stringent checks on trials and manufacturing of pharmaceutical companies.
“When drugs are of substandard quality, the disease will persist. There have been instances where doctors have prescribed a certain mg for a specific drug, but found only much lesser mg in that drug. Several medical journals also back it. At times, there is a difference even in the weight that’s mentioned on these drugs to its actual weight,” added Dr Sudhir Kumar. Doctors said the onus of arresting this practice lies both with pharma companies and the DCA.
“Quality control over drugs has deteriorated over the years and this is possible due to suspicious practices in the pharma industry and lack of action by the DCA on these industries. While the latter raids pharma stores, similar inspections should take place at the manufacturing units. But neither is that happening nor prosecutions. The govt needs to intervene here,” said K Sunil Kumar, former national joint general secretary of the Federation of Medical and Sales Representatives Associations of India (FMRAI).
He highlighted how the limited strength of drug inspectors is a concern. According to the DCA website, there are 71 drug inspectors in Telangana with majority of them attached to Hyderabad. Dr Kumar suggested that the pharma firms have a mechanism to monitor manufacturing, in order to not damage the reputation of the pharmaceutical industry.
“Unlike car manufacturers, I have rarely seen pharma companies recalling their defective drugs. Enforcement can be there from agencies, but unless pharma company owners desire to deliver quality, NSQs will be produced. The medical field deserves more attention as it deals with people’s health,” he said.
