According to the ‘NSQ Alert’ for July, issued by the Central Drugs Standards Control Organisation, 57 medicines have been declared ‘not of standard quality’ or substandard. (Getty)
While the failure may not make the drug harmful for consumption, it may make the drug less effective or ineffective
From a simple paracetamol pill to a vital cancer injection, asthma drugs or antibiotics to cure infections – medicines made by big pharmaceutical companies failed quality tests last month, an analysis of the list of substandard medicines shows.
According to the July “NSQ Alert” issued by the country’s drug regulator, the Central Drugs Standards Control Organization (CDSCO), 57 drugs have been declared “not of standard quality” or substandard.
This list is significant due to the failure of important drugs manufactured by several major pharmaceutical companies including Cipla, Aurobindo Pharma, Hetero Drugs, Hindustan Antibiotics Limited and Karnataka Antibiotics & Pharmaceuticals Ltd. While this failure may not make the drug harmful for consumption, it may render the drug ineffective or ineffective.
The warning cites the failure of two products of Mumbai-based Cipla, both of which are top-selling brands – asthma drug Budecort Respules and Urimax-D to relieve symptoms of enlarged prostate. Budecort Respules is used to control asthma symptoms such as breathlessness in adults and to prevent asthma in children under 10 years of age.
Similarly, the antibiotic manufactured by Hyderabad-based Aurobindo Pharma’s Pressclav 625 failed the quality tests. The hetero-drug Carboplatin, a cancer drug used to treat ovarian cancer and small cell carcinoma, was found to be inappropriate.
The reason for such failures ranges from problems with resolution, analysis and the presence of moisture among others.
Drugs produced by two official pharmaceutical manufacturers are also part of the failure list. HAL “ringers lactate solution for injection” was found by NSQ. It is used for fluid replacement in patients with extensive blood loss or burns. According to HAL’s detailed response, tests conducted by CDSCO called “bacterial endotoxins” can give false positive results.
Paracetamol from Karnataka Antibiotics & Pharmaceuticals Ltd – which is one of the most widely used drugs – failed the quality tests along with antibiotics Ofloxacin and Ornidazole tablets which are used to treat stomach infections. News18 contacted all drug manufacturers for their comments, but only HAL responded. Despite multiple reminders, no other drug manufacturers have responded.
HAL explains
“Ringer lactate is a very sensitive product. It often gives a false positive test for bacterial endotoxin test,” said SB Mukherjee, Assistant Director at HAL, in an email reply to News18.
“Its presence in the water used for saline or intravenous fluids causes difficulty in administration, which can sometimes be severe to fatal, due to the presence of bacterial endotoxin.” That is why this bacterial endotoxin test (BET) is required for all injectable or sterile products.”
Mukherjee said, “We take utmost care to check bacterial endotoxin test at every stage of production and the finished product is marketed only after passing the quality parameters as per specified standards.
HAL has also adopted corrective measures, including regular cleaning of production tanks and lines to prevent the development of micro-flora.
“The samples, if found positive during testing, are taken for testing by ‘gel plug method’ as per Indian Pharmacopoeia and also as per UV spectrometer as per Indian Pharmacopoeia.
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