The quality of drugs has once again come under scrutiny with 157 medicines and medical products manufactured across various states failing to meet prescribed quality standards. Of those, 44 drug samples, comprising a whopping 28 per cent, were manufactured in 37 drug firms of Himachal, as per the monthly drugs alert issued by the central drugs regulator last evening.
Of particular concern is the fact that those are used to treat both common and serious conditions such as high blood pressure, heart disease, high cholesterol, diabetes, infections, gastric disorders, pain and inflammation. Furthermore, four syrups, four misbranded products and one antibiotic have been declared spurious which is alarming.
The state has recorded the highest number of substandard medicines in the country with such firms being located in Baddi, Barotiwala, Nalagarh, Jharmajri, Kala Amb, Paonta Sahib, Parwanoo and Una.
The drugs that failed quality tests include Iron Sucrose, Rabeprazole, Diclofenac, Ondansetron and Oxytocin injections; Amoxicillin and Clavulanic Acid, Cefixime, Cefpodoxime, Telmisartan, Rosuvastatin, Atorvastatin, Gabapentin, Pregabalin and Levocetirizine tablets; Omeprazole and Itraconazole capsules; various cough syrups; vitamin supplements; and several medications for diabetes and hypertension.
Quality defects in injectable and syrup-based products are viewed with greater concern by regulatory agencies as those can have a serious bearing on the health of a patient.
As part of the continuous regulatory surveillance, drugs, cosmetics and medical devices samples from the market are analysed by the central and state drug regulators. Samples failing quality parameters are listed as monthly alerts.
A significant number of commonly used drugs such as Telmisartan (used for high blood pressure), Rosuvastatin and Atorvastatin (for cholesterol control), Rabeprazole and Omeprazole (gastric ailments), diabetes medications and antibiotics like Amoxicillin-Clavulanic Acid, Cefixime and Cefpodoxime have also been listed in the alert, raising concern among its users.
With an antibiotic manufactured in Sirmaur being declared “spurious” (fake), considered a grossly serious defect, an aspersion has been cast on the quality parameters of its manufacturer though the error pertains to a specific batch.
State Drug Controller Dr Manish Kapoor stated that notices are being issued to the manufacturers of these products and the process of recalling the affected batches from the market has begun. Detailed investigations into the cases to identify the cause behind sample failure would be enquired into as patient safety is the top priority and there would be no compromise on quality standards.
