Indian Pharmaceutical Company Zydus Lifesciences Fails 10 FDA Requirements

Indian Pharmaceutical Company Zydus Lifesciences Fails 10 FDA Requirements

Generic drug exporter Zydus Lifesciences received poor marks again in April following a Food and Drug Administration inspection of its lab in Vadodara, a city in Gujarat state on India’s western coast. Inspectors noted 10 instances where the company was not in line with Current Good Manufacturing Practices, essentially a how-to guide on making medication for the U.S. market.

According to the CNBC affiliate in India, the 10 discrepancies noted by the FDA were:

  1. Failed to review unexplained discrepancy in batch distribution
  2. Establishing sampling plans and test procedures not followed
  3. Procedures to prevent contamination didn’t include adequate validation
  4. Procedures to prevent microbial contamination not followed
  5. Failed to establish procedures to establish purity and quality of products
  6. Aseptic processing areas to monitor environmental conditions are deficient
  7. Equipment and utensils not cleaned and maintained properly
  8. Employees engaged in manufacturing drug product lack the training required
  9. Procedures for cleaning and maintenance of equipment are deficient
  10. Appropriate controls over computers not followed

The violations relating to cleaning and even training should be considered red flags by the FDA.

The FDA is often forced to wrestle with allowing imports of pharmaceuticals from labs that have demonstrated poor manufacturing practices or restrict them until the labs clean up their act. For the most part, the FDA will err on the side of supply over safety, especially in instances where the drugs made at labs with poor inspection results were not deemed dangerous.

The U.S. currently has over 300 different types of drugs in short supply. These shortages are now at record highs, CPA’s chief economist Jeff Ferry noted in an op-ed published by The Washington Times in April.

Source: University of Utah Drug Information Service

Zydus Lifesciences is a 27-year-old health sciences company. It is the fourth-largest pharmaceutical company in India. The Gujarat lab is one of its newest investments. It was first inspected in 2022. It is unclear what they produce at this particular lab, as it is not listed as a manufacturing site on Zydus’ webpage.

Zydus distributes its Indian-made medications through USA Formulations in New Jersey and Pennsylvania.

In 2019, its main lab in Ahmedabad was given a Warning Letter by the FDA.  The problems were resolved in 2022. But other facilities in the country were not in compliance with good manufacturing practices that same year. 

According to a Morning Consult poll, 84% of Americans want the FDA to ban imports of generic medicines from foreign manufacturers that have received a Warning Letter. Another 86% of survey respondents said they support the FDA testing generic medicines imported into the U.S. from foreign manufacturers that have received a Warning Letter. As it stands, Warning Letters are not necessarily import bans. Labs that have received Warning Letters have a period to correct the problems the FDA identified or face what is officially known as an Import Alert, which is a ban. 

White House data from Biden’s first year in office showed over two-thirds of generic drugs and 87% of active pharmaceutical ingredients are imported.  The U.S. is the world’s leading consumer of medication, but it is the global pharmaceutical companies that serve this market much more than domestic ones, especially on the generics side. 

For example, the U.S. has no domestic production capability for many medicines including life-saving antibiotics like penicillin. Amoxycillin –  a type of penicillin – is on the FDA drug shortage list. The U.S. has one small lab that makes a version of it, and it is a relatively new lab in Tennessee.

Zydus Lifesciences is in similar company to other Indian drug manufacturers that have had serious quality problems.  Indian pharmaceutical giant Aurobindo has also had a rough few years, with voluntary product recalls of blood pressure medication, and bad inspections as recent as June 2023. Aurobindo is the leading source of generic drug imports in the U.S.

In February, CPA released an exclusive report on Aurobindo, looking at its reliance on China for key starting materials and the financial support it gets from its government. China and India have what amounts to a choke hold on the U.S. generic drugs market.

According to Indian government and industry sources, India has the highest number of FDA-compliant labs outside the U.S., and it also receives a large share of FDA generic drug market authorizations compared to other countries. But India’s drug manufacturers often perform poorly in inspections, and product recalls are common. 

In March 2023, Zydus recalled 21,936 (30 count) and 33,096 (100 count) bottles of colchicine tablets used to treat gout. 

In October 2023, Zydus recalled 7,248 bottles of oxybutynin chloride – used to treat bladder and urinary conditions – because the medicine did not dissolve properly. 

The FDA has expressed concerns about the standards at pharmaceutical factories in India, and frequently issues warning letters to these companies for not following the required good management practices to sell medication to the U.S. 

Addressing the House Ways & Means Committee in February, Chairman Jason Smith (R-MO-8) said poor manufacturing quality was the lead cause of drug shortages. “We need to incentivize the production of high-quality drugs. We should be using tax policy and trade policy to make more medicine here in the United States,” Chairman Smith said.


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