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Drugs manufactured by Mumbai-based Cipla have come under the scanner of the regulator for failing safety and efficacy tests. Samples of Cipla’s Ibugesic 200 and 400 picked up by drug inspectors last month were found to be of substandard quality and the regulator is likely to take action against the firm, a senior official in the office of Drug Controller General of India (DCGI) said.
“The samples were picked up by the state drug inspector and the drug has failed the dissolution test and are found to be substandard,” the official told Business Standard.
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.
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 (of Ibugesic 200) and A10267 (Ibugesic 400), both manufactured by Cipla’s Kumrek unit in East Sikkim.
As part of their routine process, state drug inspectors collect random samples from the market to test for safety and efficacy. Apart from Cipla’s Ibugesic, the Central drug regulator has received similar reports of substandard medicines manufactured by various other small companies available in different states.
While the official did not disclose what action can be taken against companies manufacturing or selling substandard medicines, he said DCGI office is contemplating the penalty, which will be in line with the provisions of the Drugs and Cosmetics Act.
On Thursday, shares of Cipla ended at Rs 399.55 on the BSE, down 0.1 per cent from their previous close.
“The samples were picked up by the state drug inspector and the drug has failed the dissolution test and are found to be substandard,” the official told Business Standard.
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.
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 (of Ibugesic 200) and A10267 (Ibugesic 400), both manufactured by Cipla’s Kumrek unit in East Sikkim.
As part of their routine process, state drug inspectors collect random samples from the market to test for safety and efficacy. Apart from Cipla’s Ibugesic, the Central drug regulator has received similar reports of substandard medicines manufactured by various other small companies available in different states.
While the official did not disclose what action can be taken against companies manufacturing or selling substandard medicines, he said DCGI office is contemplating the penalty, which will be in line with the provisions of the Drugs and Cosmetics Act.
On Thursday, shares of Cipla ended at Rs 399.55 on the BSE, down 0.1 per cent from their previous close.
