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Drugmaker Sanofi has recalled four batches of painkiller medicine Combiflam due to delay in the disintegration time of the tablet.
This qualifies as a Class III recall where consumption of the product is not likely to cause adverse health consequences, a company spokesperson said. “We have acted immediately, and completed the recall for two batches, while the recall of the remaining two batches is ongoing,” she added.
The recall is from retailers across the country and comes after the regulatory Drug Controller General of India issued alerts on the drug earlier this year. The drug regulators had categorized the batches as “sub-standard” or not of “standard” quality. The drug is made at Sanofi’s Ankleshwar plant in Gujarat.
Explaining the problem, the company said: “There is a pharmaceutical parameter that requires the breakdown of a tablet in the human body to be assessed. In the case of Combiflam, though the disintegration time was delayed, doctors and patients can be assured that there is no impact on the safety and efficacy of the product. “
Appropriate remedial steps have been taken to ensure that the tablets disintegrate within the specified timelines, the company added. The 30-year old drug, Combiflam crossed revenues of Rs 162 crore.
C.M. Gulati, Editor of the drug journal MIMS told Business Line that substandard products needed to be hauled up, irrespective of whether they were made by a local or multinational company. The development comes at a time when Indian companies were facing much flak from overseas regulatory authorities for not adhering to current Good Manufacturing Practices (cGMP).
The real problem with a drug like Combiflam, Gulati said, was that it was a combination product (Ibuprofen and Paracetamol). And the development comes at a time when the Government looks to weed out irrational combinations from the market. Combinations that are from before the regulatory 1988 cut-off like Combiflam remain in the market, he said, adding that the regulator should insist that these combinations also prove their efficacy.
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