55 drugs manufactured in state found not of standard quality
Eight batches of a commonly used saline injections used to treat dehydration were found substandard along with 54 other drug samples manufactured by firms in Himachal in the monthly drug alert issued by the central drugs regulator last evening.
These 55 drugs were manufactured by 38 drug firms and they figure among 146 drug samples declared not of standard quality from various states.
Reflecting lack of adherence to key quality parameters, the injections were found contaminated with endotoxins and also having microbial contamination. Manufactured by a Baddi based firm, they have put a question mark on the manufacturing operations of the firm as eight different batches have failed key quality parameters like sterility and endotoxins testing.
Three batches of Carboxymethyl Cellulose Sodium eye drops also figure in the list as it failed various quality parameters.
Several other injection samples like Cefritz S 1.5 injection used to treat bacterial infection, Rabeprazole Sodium used for Gastroesophageal reflux and Ampivee – 500 Injection used for typhoid fever and meningitis have also been found not adhering to the requisite norms, thus bringing their manufacturing standards under the scanner.
As part of the continuous regulatory surveillance, drugs, cosmetics, medical device samples are picked from sales or distribution point, analysed and list of Not of Standard Quality (NSQ) drugs are displayed on the national drug regulators’ portal on a monthly basis. The exercise aims at generating awareness about the NSQ batches identified in the market.
Rabeflux suspension, Telmisartan & Hydrochlorothiazide tablets, Ondansetron oral solution, Albendazole and Ivermectin oral suspension, Acremox-500, Ketoconazole tablets, Sucrapolis-O Suspension, Cefixime & Potassium Clavulanate tablets, Montelukast sodium and levocetirizine hydrochloride syrup, Atorvastatin tablet and paracetamol tablets were some of the major drug samples figuring in the list.
They are used to treat common ailments like nausea vomiting, high blood pressure, bacterial infection, de-worming, bacterial infection, fungal, yeast infection, acidity, stomach ulcer, allergy, lowering cholesterol, etc.
Petben, a Benzoyl peroxide shampoo, was found not adhering to the claims made on its label while
Mamaearth Vitamin C light moisturising cream manufactured by a Parwanoo-based firm was found not conforming to Cosmetics Rules 2020 for the standards of cosmetics. It failed the test for the content of ‘Mercury’ in finished cosmetic products as specified in the Laboratory Protocol.
State Drugs Controller, Manish Kapoor, said all batches figuring in the list will be withdrawn from the market immediately and field investigation will be initiated against firms whose multiple samples are found substandard.
With parameters like appropriate assay content having been breached and presence of particulate matter being found in the injection samples, not only would the efficacy of the drugs be hit but this also reflects serious manufacturing defects necessitating the need for stricter regulation.
Himachal Tribune