Sun Pharma, others on regulator’s radar as drugs flunk quality tests

Sun Pharmaceutical Industries’s antiviral medicine and Zydus Cadila’s anti-inflammatory drugs were among the 34 samples flagged as substandard by the Central Drugs Standard Control Organization (CDSCO) during inspections conducted in January.

The Indian drugs regulator found that two samples of Sun Pharmaceutical’s antiviral medication valaciclovir hydrochloride have impurities.

Sun Pharmaceutical disputed the findings and said its internal tests of samples retained by it from the two batches found the drug ingredients are in compliance with standards prescribed by the regulator.

“We have tested the retain samples of the two active pharmaceutical ingredient (API) batches of valaciclovir hydrochloride. The API material is in compliance with the stated specification limits for related substances and all other tests,” a spokesperson for Sun Pharmaceutical said.

As such the CDSCO test may have been conducted at the distribution level and the failure could have been because of improper storage. Sun Pharmaceutical will share its internal test report with CDSCO and will work with the regulator to resolve all issues, the spokesperson said.

The regulator also flagged a sample of Zydus Cadila’s pain relief drug Depotex for failing to meet standards for dissolution. Dissolution tests are used to measure the effectiveness of a drug. “We are looking into the matter and shall initiate action,” said a spokesperson for Zydus Cadila.

The CDSCO also flagged a sample each of state-owned firm Bengal Chemicals & Pharmaceuticals Ltd’s (BCPL) de-worming drug albendazole and anti-inflammatory medicine diclofenac sodium.

BCPL’s diclofenac failed to meet the standards for disintegration, which is the rate at which the medicine is released in the body, while albendazole failed to meet dissolution standards. “We have tested our control batch of diclofenac tablets after getting the report from CDSCO, and the sample is of standard quality. However, we have sent another sample to an independent laboratory and are awaiting the results,” a BCPL official said on condition of anonymity. The state-run firm is yet to receive a report from CDSCO on the albendazole sample, the official said. Four other samples of albendazole were also flagged for failing the dissolution test, with two of them from another public-sector pharmaceutical firm, Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL). The issue with albendazole arose due to a change in standards for the drug, as dissolution tests were recently added to the standards for the product and were supposed to be effective from January this year, said B. Uday Kamath, head of quality assurance at KAPL. The drugs were manufactured in January last year and hence the dissolution test for albendazole that was added in Indian Pharmacopoeia, a set of standards for the identification of medicines, was not applicable to the drug, Kamath said. The company has replied to the drug regulator about the standard not being applicable to its product, he said. “Since the change in Indian Pharmacopoeia was announced, we have changed our process and are ahead of the benchmark for dissolution now,” he said.

Other companies whose albendazole samples failed to meet dissolution standards were Nestor Pharmaceuticals and Orissa Drugs and Chemicals.