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MUMBAI/AHMEDABAD--The US Food and Drug Administration has issued a warning letter to Zydus Lifesciences Ltd's injectables manufacturing facility at Jarod near Vadodara in Gujarat, the drugmaker said in a filing with the stock exchanges today. The warning letter comes as a result of the US FDA finding serious compliance issues at the unit, which included deficiencies in quality control, sanitisation, record-keeping, investigations into impurities and procedures for sterile drugs. 

 

In July, Zydus Lifesciences notified shareholders that its Jarod facility received an official action indicated status by the US regulator, following an audit of the facility from Apr 15-23. An official action indicated tag by the US drug regulator means the facility is at an unacceptable state of compliance with regard to current good manufacturing practices and administrative action may follow if the issues flagged are not resolved in the stipulated time.

 

The US FDA had flagged 10 observations after having inspected the unit. The key observations listed include failure to thoroughly review any unexplained discrepancy and the failure of batches, or any of their components, to meet any of its specifications. The observation pointed towards cross contamination due to inadequate cleaning and that injection batches were not thorough in evaluating all impacted batches, with some being rejected due to unknown impurity.
 
The regulator also found the sampling plans and test procedures not being followed at Zydus Life's Jarod injectables facility. The US drug regulator pointed out that during the interviews with employees responsible for sampling on Apr 15-16, 2024, employees provided inaccurate statements or refused to answer questions.
 
The drug agency observed that the procedures to prevent microbiological contamination of drug products purporting to be sterile were not followed. It also said that the equipment and utensils were not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. 

 

The news of the warning letter weighed on the company's shares, which erased gains to end 0.4% lower at 1,127.90 rupees on the National Stock Exchange. Sterile injectables are one of the most complex drugs that pharmaceutical companies produce, and they require a high level of quality control and laboratory management to ensure the safety, quality and purity of these medications. 

 

In recent times, the US FDA has increased vigilance on injectables manufacturing facilities in India. Earlier this month, the regulator sent a warning letter to Aurobindo Pharma's subsidiary Eugia Pharma Specialties, and pointed out several data integrity issues in the subsidiary's injectables unit in Hyderabad and recommended audits and an external consultant to rectify the issues, which several experts believe may take a long time.