Himachal: 29 medicine samples found not conforming to quality norms

Himachal Pradesh: 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. These 29 drugs are among the 113 samples that did not conform to quality standards at the national level and were listed in the monthly alert issued by the regulator. Two batches of Heparin Sodium Injection, which is an anticoagulant, a batch of Methylcobalamin Injection, both manufactured by Baddi firms, and Promethazine Hydrochloride manufactured in Paonta Sahib have been declared substandard. These samples were found to have serious defects such as the presence of particulate matter and lack of assay material and improper pH. Injections containing particulate matter can be a serious health risk for patients, especially in high-risk populations. Calamax Skin Balance Daily Moisturising Lotion manufactured by a Baddi-based company is also on the list, as lead was found in its sample which is not in conformity with the Cosmetics Rules, 2020. The concerned authorities have also targeted eight hair colour shampoo samples manufactured by a Chennai-based company as some of the ingredients did not conform to specifications such as m-phenylenediamine.

Apart from reasons such as inadequate assay affecting the efficacy of the drug, failure in disintegration and disintegration tests were identified as the major reasons for the drugs failing quality parameters. In the case of Ferrimac-X tablets, the sample did not meet the norms of uniformity of weight as per the Indian Pharmacopoeia (IP). Out of the 20 capsules weighed, 11 deviated from the limit of 10 per cent as per the IP, including three capsules which reported double deviation. Therefore, the tablet sample did not meet the specifications with regard to uniformity of weight of capsules. These are manufactured by a drug company based in Kala Amb. The drugs also failed quality standards due to other reasons such as misbranding and drugs not conforming to the claims written on the label. State Drug Controller Manish Kapoor said all such batches will be immediately withdrawn from the market and show cause notices will be issued to the guilty companies. Field staff will be directed to conduct a thorough investigation into the reasons and the drug companies will be asked to rectify the deficiencies. The failed drug samples include Gasnul-O Suspension, Zytum-CV Tablet, Ferimac-XT Tablet, Ombro-XL Syrup, Bisopol-5 Tablet, Ofloxacin Tablet, Pancid-40, Aceclofast, Thricof Cough Syrup, Cofzar-LS Syrup, Kefpod 100 Orange Suspension, Ozomet-PG 2 Tablet, Clarithromycin Tablet, Pantoprazole Tablet, Rabeprazole Tablet, Itraconazole Capsule, Esodens-L Capsule, Paracetamol Tablet, Albendazole and Ivermectin Oral Suspension and Glimeprid and Pioglitazone Hydrochloride Tablet.