Drug alert: Painkillers Combiflam, D Cold Total found to be substandard on failing disintegration test

In all, 60 medicines, including five others mentioned above, have failed different quality tests last month, leading to a drug alert being issued by the drug regulator

FP Staff April 21, 2017 12:00:14 IST
Drug alert: Painkillers Combiflam, D Cold Total found to be substandard on failing disintegration test

India's drug regulator, the Central Drugs Standard Control Organization (CDSCO) has once again found the popular over the counter painkiller drugs Combiflam and cold medicine D Cold Total to be substandard following its test last month.

The drug being manufactured by Sanofi India had failed the disintegration test last year after CDSCO found it to be substandard thrice -- in February, April and June, The Indian Express report said.

In 2015, one of the Combiflam batch number A151195 manufactured in the month of October, too, failed to adhere to CDSCO test.

Drug alert Painkillers Combiflam D Cold Total found to be substandard on failing disintegration test

Reuters

“Certain batches of Combiflam manufactured in 2015 were deemed substandard because the tablets showed a delay in the disintegration time. Essentially, there are several pharmaceutical parameters that are routinely assessed, one of which is to check the breakdown of a tablet in the human body. The batch identified by the CDSCO in March 2017 was also manufactured in 2015. Once we receive the official notice, we will ascertain the finding and take appropriate action," IE said quoting Sanofi India spokesperson.

Citing QuintilesIMS, a technology-driven healthcare service provider, Combiflam's annual sales stands at Rs 169 crore.

Moreover, the drug regulator also found Cipla’s Oflox-100 DT and Theo Asthalin tablets, and Cadila’s Cadilose solution to be substandard, the report said.

According to QuintilesIMS's estimates, annual sales of Cipla's Theo Asthalin drug in India is Rs 17.3 crore, and that of Oflox is Rs 20.7 crore.

In case of Cadila Pharmaceuticals’ Cadilose, the drug's annual sales stands at Rs 5.8 crore in India.

In all, 60 medicines, including five others mentioned above, have failed different quality tests last month, leading to a drug alert being issued by the drug regulator.

Updated Date:

Find latest and upcoming tech gadgets online on Tech2 Gadgets. Get technology news, gadgets reviews & ratings. Popular gadgets including laptop, tablet and mobile specifications, features, prices, comparison.

also read

Cipla launches generic respiratory drug in Germany, Sweden
Corporate

Cipla launches generic respiratory drug in Germany, Sweden

Pharmaceutical major Cipla today launched its generic drug used for treatment of asthma and chronic obstructive pulmonary disease in Germany and Sweden.

Diabetes to infections medicines: India caps the prices of 36 drugs
Economy

Diabetes to infections medicines: India caps the prices of 36 drugs

The medicines join the 348 drugs deemed essential and that are therefore subject to price caps.

Cipla Q2 net up 62% on robust sales at Rs 500 cr
Fwire

Cipla Q2 net up 62% on robust sales at Rs 500 cr

The company said domestic revenues grew by 13.5 percent to Rs 962 crore during the second quarter.