Sikkim-made Cipla drugs sub-standard

SNS, Gangtok, 15 July 2013: Drugs manufactured at Pharma major Cipla’s Sikkim unit have come under the scanner of the Drug Controller General of India for failing safety and efficacy tests. 

Samples of Cipla’s Ibugesic 200 and 400 manufactured at the company’s Kumrek unit in East Sikkim tested by drug inspectors last month were found to be of sub-standard quality. The drug controller is likely to take action against the firm, reports a leading national daily quoting a senior DCGI official. 

“The samples were picked up by the state drug inspector and the drug has failed the dissolution test and is found to be sub-standard,” it is learnt. 

According to the drug alert issued by the DCGI, the drug samples were picked up from Sikkim by the state’s Drugs and Cosmetics Cell in June. During testing, some batches of the drug failed to qualify the dissolution test. 

The alert noted two specific batches ~ A10466 (Ibugesic 200) and A10267 (Ibugesic 400), both manufactured at Cipla’s Kumrek unit. 

However, Cipla said it had not received any communication from DCGI for recall of the drug. 

“Cipla has not received any letter from DCGI to recall batches of Ibugesic tablets in the month of June,” the company said in response to a query. Ibugesic, a combination of ibuprofen and paracetamol, is widely prescribed for pain relief mainly to patients with symptoms of rheumatoid arthritis and osteoarthritis.