Monday, 16 May 2016

It’s not only Combiflam, more drugs under regulator’s radar

The DGCI’s list includes several popular painkillers, where the regulator has raised concerns ranging from quiality to composition (Shutterstock)

A day after French major Sanofi announced a recall of some batches of its popular painkiller Combiflam, India’s drug regulator said over102 medicines have been highlighted for quality concerns and withdrawal in the last five months. The list includes several popular painkillers.
The Drug Controller General of India (DCGI), the country’s apex drug regulation body, every month prepares an alert list of medicines that have some quality issues.
In the last five months, about 102 medicines have failed the tests and are under the category of spurious, substandard, adulterate, or misbranded medicines.
Some of the medicines that appear on the monthly alert list issued by the government includes Cipla’s CIP-ZOX, Macleods Pharmaceutical’s Orcerin, Indian Drugs and Pharmaceuticals Ltd’s Pantoprazole, Ipca Laboratories’ Zerodol-SP and Karnataka Anibiotics & Pharmaceutical Ltd’s Norfloxacin.
“All drugs listed under the drug alert list should be recalled with immediate effect. We have found some serious problems with the making of the drug because of which we have highlighted quality concerns. Hence, recall is necessary for all companies,” GN Singh, DCGI, told HT. “All these companies do recall the problematic batches from the market, but they do it silently, simply to keep their brand image unhurt.”
Both, Indian Drugs and Pharmaceuticals Ltd and Karnataka Anibiotics & Pharmaceutical Ltd, are run by the government to produce cheap generic drugs.
Cipla’s drug CIP-ZOX, which is used to treat muscle spasm, has been highlighted due to its failure in disintegration test, similar to the failure of Combiflam, as per the drug alert list of February 2016.
Disintegration tests are used to assess the time it takes for tablets and capsules to break down inside the body and are used as a quality-assurance measure, according to the US Food and Drug Administration (FDA).
Macleods Pharmaceutical’s Orcerin, which is used to treat joint diseases such as osteoarthritis failed the test for “related substances” in April 2016. The test shows presence of impurities in the drug.
Ipca Laboratories’ Zerodol-SP tablets, used for relief of pain and moderate fever, failed the test for ‘Identification and Assay’ in December 2015. The test measures the clinical impact and efficacy.
Mail sent to the companies are awaiting response.
Sanofi on Thursday announced that it is recalling some batches of Combiflam after the country’s drug regulator Central Drugs and Standards Control Authority (CDSCO) found the lots to be substandard.
The CDSCO said — in notices posted on its website in February and April — it found some batches of Combiflam to be “not of standard quality” as they failed disintegration tests.
The batches cited by CDSCO were manufactured in June 2015 and July 2015 and carried expiry dates of May 2018 and June 2018, according to the notices.
The Indian drug regulator has also raised concerns over the quality of the painkiller.