Delhi govt cracks down on fake and substandard medicines
A committee recently set up by the Central government to review 349 fixed-dose combination medicines had said in its report that getting the quantity of one of the components of FDCs wrong may result in toxicity.delhi Updated: Aug 15, 2018 04:01 IST
As part of its crackdown on the spurious drugs market, the Delhi government tested 292 selected drug samples over the past six months and found five to be spurious and 13 of substandard quality.
The five fake samples were being illegally manufactured at a warehouse in Kirari in northwest Delhi.
“The raid was conducted in March on information that medicines were being manufactured illegally in these warehouses. Lab tests of the samples collected confirmed that the drugs were spurious and did not contain active ingredients,” said AK Nasa, head, office of state drug control department, Delhi.
“Till now, the number of drugs that have failed the quality test is less than last year,” said Nasa. In the financial year 2017-18, of the 584 samples tested, 30 were found to be below standard quality.
Four were a combination drug of domperidone and pantoprazole, which are used to treat acidity, heartburn, nausea and vomiting. The fifth drug was an antihistamine used to treat allergies, the government report said. A court case has been registered against the people caught in the raid.
The antibacterial drug cefuroxime and the painkiller diclofenac sodium failed quality test because they lacked “uniformity of weight”, which means the weight of individual tablets deviated from the average weight. One sample of albutamol syrup used for asthma management was found to have an abnormal pH level. A fixed dose combination of ofloxacin and metronidazole was found to have a higher quantity of metronidazole.
A committee recently set up by the Central government to review 349 fixed-dose combination medicines had said in its report that getting the quantity of one of the components of FDCs wrong may result in toxicity.
“In case of minor defects, such as the sample failing the uniformity of the weight test, the impact on health is not much. However, if it is category A or B defects, meaning that the drugs are either spurious or the active ingredient is very less than intended, the drugs will fail to act,” said Nasa.
Following the raids, companies manufacturing the drugs that failed the quality test may face a suspension for a fortnight to a month or cancellation of their licence, depending on the magnitude of offence.
Action was additionally initiated against 207 medicine stores, both wholesale and retail, for not maintaining records.
“Several pharmacies did not maintain a register for the schedule H1 drugs (high-end antibiotics, including TB drugs) and others were found to be selling prescription drugs without asking for a prescription. Some did not have a pharmacist on duty while a few wholesalers did not maintain a proper cold-chain to store medicines to ensure viability,” said Nasa.
“The licences of most of these shops have already been suspended and the rest are being processed,” he added.
“It is essential for the drugs to have the prescribed amount of active ingredient. If the active ingredient is less it will be ineffective, if it more, it will cause toxicity, which is more harmful,” said Dr Naresh Gupta, professor of medicine at Lok Nayak Hospital.
“Moreover, apart from the active ingredient there is also a risk of contamination if proper manufacturing practices are not followed. As for the spurious drugs without the active ingredient, very few would be seen in the market nowadays as it makes no economic sense; several active ingredients are imported from China and are cheap,” said Sanjay Bajaj, a Delhi government pharmacist.
First Published: Aug 15, 2018 04:01 IST