12 drugs manufactured in state found substandard

Ambika Sharma

Solan, May 17

As many as 34 drug samples, including 12 manufactured in Himachal, were declared substandard while one was found spurious in the monthly alert issued today by the national drugs regulator, Central Drugs Standard Control Organisation.

All cases to be examined

The field staff will examine all such cases to know what led to substandard drug manufacturing at these units. All batches which figure in the list will be withdrawn from the market. Manish Kapoor, deputy drugs controller, baddi

As many as 895 drug samples were tested from across the nation. Out of these, 859 were found adhering to the standard quality while 34 were declared not of standard quality. One was found spurious. Those found spurious also included a veterinary drug.

Among the drugs declared substandard from Himachal were Astrazol injection, Astrizo tablets, Misoprostol tablets, Amoxycillin capsules, Paracetamol oral suspension, Finaviv tablets, Pantoprazole and Domperidone capsules, Rantidine Hydrochloride tablets and Levocetirizine and Ibuprofen tablet. Enrofloxacin injection, which is used to treat bacterial infection in animals, also figures in the list.

Samples of loose green colour capsules, purported to contain Tramadol and Pregabalin, which were lifted by the state drugs control administration during a raid in an unauthorised manufacturing facility, also figure in the list. The manufacturers are based in the Baddi-Barotiwala-Nalagarh, Kala Amb as well as Paonta Sahib industrial clusters.

These drugs are used for breast cancer treatment besides being used to treat common ailments like high level of calcium in the blood, fever, hair loss, acid reflux disease like heartburn and chest discomfort, pain and allergy.

Issues like lack of assay content, dissolution, uniformity in weight, presence of particulate matter, etc, have been identified as the main reasons for the drug samples failing in quality parameters.

Manish Kapoor, Deputy Drugs Controller, Baddi, while confirming the news said, “The field staff will examine all such cases to know what led to substandard drug manufacturing in these pharmaceutical units. All batches which figure in the list will be withdrawn from the market and the firms will be directed to explain their position.”

He said there would be no compromise on quality drugs manufacturing and whatever laxities come to fore would have to be rectified by the manufacturers.