New Delhi: Reacting to the recent news of as many as 53 medicines failing the drug quality test, the Central Drugs Control Standards Organisation (CDSCO) said today (September 26) that such a list of drugs is released every month and that this is a routine process.
As per the list for the month of August, commonly used medicines such as some brands of antacids, anti-diabetic drugs and paracetamol, have failed the quality test. These drugs were found to be ‘not of standard quality’ (NSQ).
These drugs don’t contain any harmful materials as spurious drugs do, but many do not work adequately against the disease that they are supposed to.
So, while patients may not be harmed directly by taking these drugs, it may result in their consuming an inadequate dosage, due to the presence of an insufficient quantity of ingredients in the drugs as against what is supposed to be present in them.
The resultant inadequate consumption of drugs, therefore, can aggravate disease despite the patient believing that she has taken the dosage as prescribed.
“Such [a] list is released every month and this shows that the Drugs Controller General of India (DCGI) is constantly monitoring the quality of medicines and taking action against manufacturing companies who are selling drugs which are of NSQ … NSQ is mostly minor in nature which is not life-threatening,” an unnamed source in the CDSCO was quoted as saying by ANI.
The CDSCO has not made it clear in its statement as to what action it will take against the defaulting pharma companies.
It randomly samples particular batches of a given drug. Since only certain batches of different drugs are tested, it is wrong to construe that all batches would be NSQ.
The CDSCO then takes up the matter with the drug companies whose drugs do not pass the test.
Pan D (antacid), Telmisartan (for hypertension), Glimepiride (anti-diabetic), calcium supplements, paracetamol, amoxicillin and potassium clavulanate tablets (antibiotics), vitamin B-complex, Rolled Gauze (for dressing), were among other drugs that failed the CDSCO’s quality test.
Many popular drug makers figure in the list.
The full list of the NSQ drugs that the CDSCO – which is the Union government’s drug regulator – and state drug regulators released for August can be found here and here.
The list contains the generic names of the drugs and their respective manufacturing companies.
Talking to News18, at least two companies tried to wash the problem off their hands. They said the samples under question were not produced by them but illegally made by entities who used their labels.
“The products mentioned seem to be spurious and not manufactured by Alkem. The company is engaging with the authorities on this matter,” an Alkem Laboratories spokesperson was quoted as saying.
Sun Pharma took a similar approach. “We have investigated the matter and found that Pulmosil (sildenafil injection), batch no KFA0300; Pantocid (pantoprazole tablets IP), batch no SID2041A, and Ursocol 300 (ursodeoxycholic acid tablets IP), batch no GTE1350A are spurious. The said batches tested by the regulatory authority are not manufactured by Sun Pharma,” the company was quoted as saying.
The CDSCO has not commented on these claims by the pharmaceutical companies.
