Tests by the Central Drugs Standard Control Organisation have found painkiller Combiflam and cold medicine D Cold Total to be below the accepted standards, The Indian Express reported on Friday. The regulatory organisation has issued a drug alert for 60 medicines, including Cipla’s Oflox-100 DT tablets and Theo Asthalin tablets, as well as Cadilose solution manufactured by Cadila, the English daily said.
The list of medication found to be sub-standard included popular over-the-counter painkillers, medicines for anti-allergy, fever, cold, diarrhoea, constipation, and supplements among others, NDTV reported.
Sanofi India said its Combiflam batch’s failing the disintegration test had no impact on its safety and efficacy. The quality regulator had found painkiller Combiflam to be substandard three times last year, prompting a recall by its manufacturer Sanofi India. “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. Once we receive the official notice, we will ascertain the finding and take appropriate action,” Sanofi India’s spokesperson was quoted as saying.
The English daily report said Cipla and Reckitt Benckiser Healthcare India had not responded to its queries. Cadila told The Indian Express that it could not comment on the matter as it had not received a notice from the CDSCO yet.