37 drug samples from 33 state units found substandard

As many as 37 drug samples, including eight injections and an eye drop, from 33 pharmaceutical units of the state have failed to conform to quality parameters as they figure in the monthly alert issued last evening by the Central Drugs Standard Control Organisation (CDSCO).

They figure among 90 drug samples which figure in the list from across the nation.

They are used to treat common ailments like bacterial infection, epilepsy, vitamin deficiency, fungal infection, bronchitis, hypertension, cough, ashthma, wheezing, relieving pain and swelling associated with post-operative wounds and inflammatory disease, lower cholesterol and reduce the risk of heart disease and gastroesophageal reflux disease.

A majority of drug samples suffer from the issues like uniformity of weight and assay, misbrand, presence of spots and discolouration, presence of particulate matter in the eye drops and injections which are considered serious defects by the CDSCO pointing towards grave laxity in their manufacturing.

With the CDSCO focusing on the quality of injections as many as eight found mention in the list. They comprise Prochlorperazine Mesylate injection used to treat nausea and vomiting failed the test ‘pH’ as per Indian Pharmacoepia as specified in the laboratory protocol, Ambilip injection suffers from Bacterial endotoxins and lacks assay of amphote phosphate injection as well a Betamethsano sodium, Phosphate injections were found having particulate matter, while Enroxacin injection used to treat respiratory tract injection suffers from ‘Ph”issues.

Acyclotech injection used for viral infection was found lacking assay which hits its efficacy.

Nataprime eye drops which also finds a place in the list suffers from sterility issue putting a question mark over its quality.

State Drugs Controller Manish Kapoor said all batches of drugs figuring in the list would be immediately withdrawn and notices would be served to the erring firms. Besides, the field staff would enquire into the manufacturing laxities in the related firm in detail.

Among the major drug samples which figure in the list are Cefem -200 tablet, Cefpodoxime Proxetil dispersible tablet, Divalproex Sodium SR tablet, vitamin B complex tablet, Itraconazole capsule, cefixime dispersible tablets, orsemide tablets, cough DM syrup, Montelukas, Ciprofloxacin Hydrochloride tablet, Tyrpsin Chymotrypsin tablet, Rozutin 10 tablet and Rabalkem capsule.