According to the July “NSQ Alert” issued by the Central Drugs Standards Authority, 57 drugs were declared to be of “substandard quality” or substandard. (Getty)
While failure may not make the drug harmful for consumption, it may make the drug less effective or ineffective
An analysis of the list of substandard medicines shows that – from simple paracetamol pills to vital anti-cancer injections, anti-asthma drugs or antibiotics to treat infections – drugs produced by Big Pharma failed quality checks last month.
According to the July “National Quality Alert” issued by the Central Drug Standards Organization (CDSCO), the national drug regulatory authority, 57 drugs were declared to be of “substandard quality” or substandard.
This list is important because key drugs produced by several top pharmaceutical companies including Cipla, Aurobindo Pharma, Hetero Drugs, Hindustan Antibiotics Limited and Karnataka Antibiotics & Pharmaceuticals Ltd have failed. Harmful to consumption, but may reduce the efficacy of the drug or be ineffective.
The alert mentioned that two products of Mumbai-based Cipla, both of its best-selling brands – anti-asthma drugs Budecort Respules and Urimax-D – failed to relieve symptoms of prostate enlargement. Budecort Respules is used to control asthma symptoms such as shortness of breath in adults and to prevent the occurrence of asthma in children under 10 years old.
Similarly, Pressclav 625 antibiotic manufactured by Hyderabad-based Aurobindo Pharma also failed the quality test. Hetero's carboplatin, an anti-cancer drug used to treat ovarian cancer and small cell lung cancer, was found to be substandard.
Reasons for such failures include problems with dissolution, assay, and presence of moisture.
Drugs produced by two public sector drug manufacturers are also on the unqualified list. HAL's “Lactated Ringer's Solution for Injection” is certified as NSQ. It is used for fluid replacement in patients with severe blood loss or burns. According to HAL's detailed response, the test called “bacterial endotoxin” conducted by CDSCO may give false positives.
Paracetamol, one of the most commonly used drugs, and tablets of ofloxacin and ornidazole, the antibiotics used to treat stomach infections, failed quality tests at the Karnataka Antibiotics and Pharmaceuticals Ltd. News18 contacted all drug manufacturers for comment but only HAL responded. Despite repeated reminders, no other drugmakers responded.
HAL clarification
“Lactated Ringer is a very sensitive product. There have been many false positives in the bacterial endotoxin test,” HAL Assistant Manager SB Mukherjee said in an email reply to News18. ”
“The presence of bacterial endotoxins in water used for saline or intravenous infusions creates stringent requirements for dosing and can sometimes become serious or even fatal due to the presence of bacterial endotoxins. This is why any injectable or sterile product must be Reasons for Bacterial Endotoxin Testing (BET).
“We check bacterial endotoxin testing with great care at all stages of production and the finished product is released only after it meets the quality parameters of the stipulated standards,” Mukherjee said.
HAL has also taken corrective measures, including regular disinfection of production tanks and production lines to prevent the growth of microbial flora.
“If found positive during the testing, the test will be carried out through 'gel clot method' as well as UV spectrophotometer as prescribed in the Indian Pharmacopoeia.”
