Issues that Union and state regulators detected during their monthly inspections in June include contamination and incorrect labelling.
New Delhi: Batches of as many as 185 drugs were found to be not of standard quality (NSQ) by Union and state drug regulators during their monthly inspection in June. The results of their inspections were released on Friday (July 18).
A drug is labelled NSQ if it does not meet the quality standards laid down in the Indian laws governing drugs.
The Central Drugs Standard Control Organisation (CDSCO) found batches of 55 drugs NSQ, with batches of the remaining 130 being flagged by various state drug regulators. The CDSCO is India’s drug regulator at the Union government level.
This is not a one-off list. It is a monthly document that the CDSCO publishes. The exercise became regular about a year ago.
“As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point and analysed, and the list of spurious [NSQ] drugs are displayed on the CDSCO portal on a monthly basis,” the CDSCO said.
The purpose of displaying the list is to make stakeholders aware about the NSQ batches identified in the market, it added.
The drugs that the CDSCO and state regulators most commonly found to be NSQ were mainly antibiotics, vitamin and calcium supplements, and anti-hypertensives (used for controlling blood pressure) in oral and injectable forms.
The companies mentioned in this article are not the only ones whose products were found to be NSQ. We have only considered companies that made either multiple batches of a given drug that were found sub-par, or those that have manufactured various drugs that were found sub-par.
It must be mentioned here that the CDSCO’s and the states’ labs only test a certain batch(es) of a particular medicine. If one batch of any drug has been red-flagged, it does not necessarily mean that all its batches would be substandard.
Common ‘errors’
One of the most serious risks associated with NSQ drugs is improper sterility. This means that the drug contains harmful microorganisms that can lead to infection in a patient’s body after ingestion. This could potentially cause extremely serious complications in patients, like sepsis or even death due to acute infection.
The other common problem that some drugs have is that they contain ‘particulate matter’ – particles that inadvertently enter the drug during the manufacturing process. These particles can contaminate the drug.
A ‘description’ error is one in which a drug’s physical appearance does not match its prescribed appearance as per regulation. For example, if a tablet is described in regulation as having a white colour but a patient finds it to be orange, the tablet would have a description error.
Several medicines were reported as experiencing ‘loss on drying’. This error reflects the lack of moisture in drugs, which may cause microbial growth in them, potentially causing infection if ingested.
A drug is labelled as having assay errors when an ingredient in it is found in a quantity that is higher or lower than what is mentioned on its label. A higher amount would mean an overdose and a lower amount would result in an underdose – the latter would lead to a situation where a patient even after consuming the prescribed strength of a drug ends up ingesting a lower quantity of some ingredient. This can lead to their disease getting worse.
‘Extractable volume’ errors usually occur with vials. If the liquid that is to be extracted from a vial using a syringe is present in a quantity greater or lower than as labelled, this can again lead to an overdose or underdose of the drug given in injectable form.
‘Dissolution’ errors can adversely affect the absorption of a drug.
What did the CDSCO find?
Six drugs manufactured by Paksons Pharmaceuticals Private Limited were found to be NSQ. These include a dexamethasone sodium phosphate injection – an antibiotic; an ascorbic acid injection, used as a vitamin C supplement; an adrenaline bitartrate injection, used during cardiac arrest; an ondansetron injection, used for treating nausea caused by cancer medicines; and a gentamicin injection, used for treating bacterial injections.
The company’s diclofenac sodium injection, used as a pain killer, had extractable volume issues in its vials.
Four batches of Phaex Polymers Private Limited’s colestyramine (used to treat high cholesterol) and three batches of its sodium polystyrene sulfonate (for regulating potassium levels) reported ‘loss of drying’ mistakes.
Zee Laboratories’ tranexamic acid injection, used for preventing excessive loss of blood during surgery in patients suffering from haemophilia, reported assay problems.
On the other hand, its glipizide & metformin tablets, used for treating high blood sugar, had a description error.
Two batches of Overseas Health Care Pvt Ltd’s calcium aspartate, calcium orotate, calcitriol minerals and vitamin tablets, which are used to supplement calcium and micronutrients like zinc and vitamins to treat deficiencies, had compromised assays for almost all of their ingredients.
Martin & Brown BioSciences Pvt Ltd’s calcium gluconate injection had particulate matter and description errors along with extractable volume issues. Three batches of its rabeprazole sodium injection – used to treat acid reflux – also had particulate matter and assay problems.
Two batches of E.G. Pharmaceuticals’ vitamin C injection and vitamin B12, folic acid and niacinamide injection had particulate matter and description errors.
Two batches of Healers Lab’s telmisartan tablets (used to manage blood pressure) had dissolution issues.
What did state drug regulators find?
State drug regulators too found serious errors in some drugs.
Five batches of Puniska Injectables’s sodium chloride injection had serious sterility problems. These injections have multiple purposes. They are primarily given in cases of dehydration to restore electrolytes (sodium and chlorine).
Similarly, Paschim Banga’s dextrose injection, which is used to normalise blood sugar levels, and its sodium chloride injection, had sterility issues.
Thirteen batches of Martin & Brown BioSciences’ calcium and vitamin D3 tablets had description errors.
Vivek Pharmachem’s paracetamol and ciprofloxacin hydrochloride tablets had description and dissolution issues respectively.
Safe Care Life Sciences’s mecobalamin 2,500 mg injection, which is used for vitamin B12 supplementation, had 2.38 mg per ml of mecobalamin against the labelled claim of 2,500 mg per ml in its vial.
Two batches of Oscar Remedies’s ciprofloxacin & dexamethasone eye/ear drops had 943.33% more ciprofloxacin than the labelled amount.
The full lists of NSQ drugs made by the CDSCO and state regulators can be found here and here respectively.
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