29 drug samples fail to conform to quality norms
The Central Drugs Standard Control Organisation (CDSCO) declared 29 drug samples, including three injections, manufactured by 22 firms in the state as substandard last evening. The 29 drugs figure among 113 samples that had failed to conform to quality parameters nationally and were listed in the monthly alert issued by the regulator.
Two batches of Heparin Sodium injection, which is an anticoagulant, one batch of Methylcobalamin injection, both manufactured by Baddi firms, and Promethazine hydrochloride manufactured in Paonta Sahib have been declared substandard. Serious defects like the presence of particulate matter and the lack of assay content and inappropriate pH were found in these samples.
Injections that contain particulate matter can be a serious health risk for patients, especially those in high-risk population. The Calamax skin balance daily moisturising lotion manufactured by a Baddi-basded company is also on the list, as its sample contained lead that does not conform to the Cosmetic Rules, 2020.
The authorities concerned have also targeted eight hair colour shampoo samples manufactured by a Chennai-based company as some contents do not conform to specifications like m-phenylenediamine.
Besides causes like inadequate assay that hits the efficacy of a drug, the failure in the dissolution and disintegration tests were identified as the major reasons for drugs failing quality parameters.
In case of Ferrimack-X tablet, the sample did not meet the criteria for the uniformity of weight, as per Indian Pharmacopeia (IP). Out of 20 capsules weighed, 11 deviated from the 10 per cent limit, as per the IP, including three capsules that were reported double deviation. Hence, the tablet sample did not meet the specifications with respect to the uniformity of weight of capsules. They are manufactured by a Kala Amb-based pharmaceutical company.
Other causes like misbranding and drugs not conforming to the label claims also led to the drugs failing quality parameters. State Drugs Controller Manish Kapoor said that all such batches would be immediately withdrawn from the market and show-cause notices would be issued to the erring firms. The field staff would be instructed to thoroughly enquire into the causes and the drug firms would be required to remove the shortcomings.
The failed drug samples comprise Gasnul-O suspension, Xytum-CV tablets, Ferrimack-XT tablets, Ombro-XL syrup, Bisopol-5 tablets, Ofloxacin tablets, Pancid-40, Aceclofast, Thricof cough syrup, Cofzar-Ls syrup, Kefpod 100 Orange suspension, Ozomet-PG 2 tablets, Clarithromycin tablets, Pantoprazole tablets, Rabeprazole tablets, Itraconazole capsules, Esodense-L capsules, Paracetamol tablets, Albendazole and Ivermectin oral suspension and Glimepride and Pioglitazone Hydrochloride tablets.
