A povidone-iodine solution, a widely used topical antiseptic for preventing and treating infections in wounds, besides surgery was among 59 drugs declared substandard in the monthly alert issued by the Central Drugs Standard Control Organisation (CDSCO) on Friday.
These drugs have been manufactured by 31 firms located in Baddi, Barotiwala, Nalagarh, Kala Amb, Paonta Sahib, Solan, etc.
Various batches of Telmisartan tablet, manufactured by a Baddi-based company and drug used for hypertension, failed quality parameters. The company has been found defaulting since months on manufacturing this drug.
Key issues like sterility assay, uniformity of weight, lack of assay content and presence of particulate matter have been found to be the key reasons of drug samples failing quality parameters. They comprise the grossly substandard drugs requiring immediate attention of the authorities.
Quality issues have also been flagged in several injections, including methylcobalamin that is used to treat deficiency of vitamin B12 in body, tranexamic acid injection used to control or prevent excessive or heavy bleeding during dental procedures in patients with hemophilia, calcium gluconate injection used for increasing calcium level in body, vitamin C injection IP and vitamin B12, folic acid and niacinamide injection.
The Mupirocin ointment used to treat secondarily infected traumatic skin lesions due to specific bacteria, iron sucrose injection used to treat iron deficiency have also found a place in the list.
At least six batches of Nalagarh-based firm’s calcium and vitamin D3 tablets failed quality parameters due to description issues. Altogether 14 drug samples of this firm figure in the list, thus putting a question mark on its quality control measures.
Other drugs figuring in the list include amoxicillin potassium clavulanate tablets, ampicillin and cloxacillin capsules, levocetrizine tablets, domperidone & paracetomal tablets, aceclofenac paracetamol and chlorzoxazone tablets, pabeprazole sodium and domperidone capsules and Ibuprofen IP 400.
They are used to treat common ailments, including gastroesophageal reflux, bacterial infection, fever, vitamin deficiency,migraine, blood pressure, heart ailments etc
Dr Sanjay Aggarwal, a Solan-based surgeon, said “Povidone-iodine solution, if found deficient in requisite assay and deviating from the safe pH level can have adverse impact. These are critical factors for the effectiveness, solubility and stability of a drug. If the pH is acidic it can burn the skin as it is supposed to have a neutral pH. Its long-term storage after its expiry date can alter its composition, thus making it toxic.”
“Similarly, the lack of assay can have far-reaching health impact on a patient as a medical practitioner will prescribe a higher dosage, which are bound to increase the side effects,”said Dr Aggarwal.
State Drugs Controller Manish Kapoor said all such drug samples of listed batches would be immediately withdrawn and the filed staff would probe the causes behind samples failing quality parameters.
