IPA Defends Members After CDSCO Flags Quality Failures
Among the drugs identified as Not of Standard Quality (NSQ) were popular products such as Alkem’s Clavam 625 and PAN-D, Sun Pharma’s Pantocid and Pulmosil, and Glenmark’s Telma H.
The Indian Pharma Alliance (IPA), representing 23 major pharmaceutical companies, has come to the defense of its member firms after the Central Drug Standard Control Organisation (CDSCO) flagged 53 commonly used medicines for failing quality tests in its August 2024 report.
Among the drugs identified as Not of Standard Quality (NSQ) were popular products such as Alkem’s Clavam 625 and PAN-D, Sun Pharma’s Pantocid and Pulmosil, and Glenmark’s Telma H.
The IPA emphasized the importance of distinguishing between NSQ and spurious drugs.
It explained that NSQ drugs may contain issues such as incorrect ingredient quantities or labeling errors, while spurious drugs are counterfeit products designed to deceive consumers.
Conflating the two terms, the IPA warned, could unfairly implicate legitimate manufacturers and damage India’s reputation as a trusted exporter of pharmaceuticals.
Pharma Companies Deny Allegations
In response to the report, several major pharmaceutical companies, including Sun Pharma, Glenmark, and Alkem, denied producing the flagged batches, asserting that the identified products were spurious, and not manufactured by them.
Torrent Pharma also clarified that the flagged batch of Shelcal 500 did not belong to them.
Pharma experts, including activist Dinesh Thakur, have called for the CDSCO to release detailed investigations to determine whether the flagged drugs are counterfeit or genuine.
According to a 2022 study by Assocham, about 25% of drugs in India are fake, counterfeit, or substandard.
The recent case of antibiotics supplied to Maharashtra government hospitals, which were found to be talcum powder mixed with starch, has further highlighted the issue.
In response to the spurious drug crisis, pharmaceutical companies have implemented QR codes and other unique features in their packaging to differentiate genuine products from fakes.
The government has also ramped up inspections and revoked the licenses of 18 pharma companies in December 2023.
However, experts stress that greater vigilance and tighter regulations are needed to combat the growing threat of counterfeit drugs in India’s pharmaceutical market.
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