20 drug samples made in state found substandard

Twenty drug samples manufactured by 17 pharmaceutical units of the state were declared substandard, including one being declared spurious, in the monthly alert issued today by the Central Drugs Standard Control Organisation (CDSCO).

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They figure among 64 drug samples declared substandard by the Central and various state laboratories nationally. These drugs comprise Paziva 40 and Pantomed 40, both of whom are used for gastroesophageal reflux disease. These drugs are manufactured by Kala Amb based pharmaceutical units. Another drug Moxymed CV, used to treat bacterial infection, is manufactured by a Baddi based unit in the CDSCO’s list.

To be withdrawn

• State Drugs Controller Manish Kapoor says the batches of drugs figuring in the monthly alert will be immediately recalled from the market
• The field staff will initiate an in-depth probe into the causes of these drugs failing quality parameters

Telmisartan 40, manufactured by Baddi based pharmaceutical company, is also included in the list of states. It is used for treating high blood pressure. The actual manufacturer, as per label claim, however informed the authorities that the said batch of the product has not been manufacturer by them and that it is a spurious drug.

The other drugs which figure in the list are used for common ailments like seasonal allergy, diarrhoea, bacterial infection, diabetes, constipation, blood clots, severe hypersensitivity reaction, severe pain, anxiety and common cold. The CDSCO was according special attention to injection samples and as many as four injection samples have been declared substandard for failing to adhere to quality parameters.

Causes like lack of assay content, dissolution and presence of particulate matter have been declared as the cause behind these drug samples lacking quality parameters. They are considered serious defects as per the CDSCO guidelines and need a thorough investigation at the manufacturing level. They affect the efficacy of the drugs.

State Drugs Controller Manish Kapoor said batches of drugs figuring in the monthly alert will be immediately recalled from the market and the field staff will initiate an in-depth probe into the causes of these drugs failing quality parameters.

Other drugs which figure in the lists include Amoxycillin & Potassium Clavulanate tablets, Glycimet-SR-500 tablet, Rifmin 550, Fexofenadine Hydrochloride tablet, Laxnorm solution, Heparin Sodium injection, Nunim-Cold tablet, Adrenaline injection, Vingel XL pro gel, Cefoperazone & Sulbactam injection, Heparin Sodium injection and Klozaps-ES tablets.