From a simple paracetamol pill to a crucial anti-cancer injection, anti-asthmatic drug or antibiotics to cure infections — drugs manufactured by big pharmaceutical companies failed quality testing last month, an analysis of the list of substandard medicines reveals.
According to the “NSQ alert” for July, released by the country’s drug regulation watchdog Central Drugs Standards Control Organisation (CDSCO), 57 drugs have been declared “not of standard quality” or substandard.
This list holds importance due to the failure of crucial medicines manufactured by several top pharma firms, including Cipla, Aurobindo Pharma, Hetero Drugs, Hindustan Antibiotics Limited and Karnataka Antibiotics & Pharmaceuticals Ltd. While this failure may not make the medicine harmful for consumption, it might make the medicine less effective or ineffective.
The alert mentions the failure of Mumbai-based Cipla’s two products, both of which are top-selling brands — anti-asthma drug Budecort Respules and Urimax-D to relieve the symptoms of enlarged prostate gland. Budecort Respules is used for controlling symptoms of asthma such as shortness of breath in adults and to prevent the occurrence of asthma in children aged less than 10 years.
Similarly, the antibiotic manufactured by Hyderabad-based Aurobindo Pharma’s Pressclav 625 failed the quality tests. Hetero drug’s Carboplatin, which is an anti-cancer medication used for the treatment of ovarian cancer and small cell lung cancer, was found to be sub-standard.
The reason for such failures ranges from problems in dissolution, assay, and presence of moisture among others.
Drugs manufactured by two public-sector drug makers are also part of the failure list. HAL’s “ringers lactate solution for injection” was found NSQ. It is used for fluid replacement in patients with extreme blood loss or burn injuries. According to HAL’s detailed response, the testing conducted by the CDSCO called “Bacterial Endotoxins” can give false positives.
Karnataka Antibiotics & Pharmaceuticals Ltd’s paracetamol — which is one of the most commonly used medications — failed the quality testing along with antibiotic Ofloxacin and Ornidazole tablets which are used to treat stomach infections. News18 contacted all the drug makers for their comments, but only HAL responded. Despite multiple reminders, no other drug makers have replied.
HAL Clarifies
“Ringer lactate is a very sensitive product. It gives a false positive test for Bacterial Endotoxins Test many times,” said SB Mukherjee, assistant manager at HAL, in an email response to News18.
“The presence of it in the water used for saline or IV fluids gives rigours on administration which may at times become severe to fatal, because of the presence of Bacterial Endotoxin. That’s the reason this Bacterial Endotoxin Test (BET) is a must for any injectable or sterile product.”
Mukherjee said, “We are taking utmost care to check bacterial endotoxin test at all manufacturing stages and the finished product is marketed only after passing the quality parameters as per standards specified.”
HAL has also adopted measures for rectification, including periodic sanitisation of manufacturing tanks and lines to prevent the development of microbial flora.
“The samples, if found positive during testing, are taken for testing by ‘gel-clot method’ as per Indian Pharmacopeia and also as per UV Spectrophotometer as per Indian Pharmacopeia.”
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