The incidence of failure to meet the quality norms in the pharmaceutical sector has been on the rise. Now, Hyderabad-based Matrix Laboratories is the latest to be hauled up for such violations. The company, a subsidiary of the US-based Mylan Laboratories, was issued a notice by the World Health Organisation (WHO) on the grounds of major deviations from WHO’s good manufacturing practices (GMP) guidelines.
The notice is in relation to the anti-retroviral (ARV) drugs that Matrix supplies to WHO for its HIV/AIDS programme. A suspension of such a status could impact Matrix to the extent of its sales to WHO for these products.
In the notice, the WHO quality assurance and safety department said that during an inspection of Matrix’s plant in Vizianagaram between May 25 and May 28 this year, failure to ensure appropriate control of recording of data was a significant deviation that was mentioned. WHO sent a report to the company in June to which Matrix responded with supporting documents on corrective action that was taken within a month.
The WHO team, however, was not satisfied with the company’s responses, which it said “differed from the explanation given at the time of the inspection”. The global organisation has warned the company that it may consider suspension of the products, which were granted pre-qualified status, an action which could severely impact Matrix.
This can be a significant issue, if it is not addressed in time. WHO notices are as significant as those issued by the US FDA. WHO, in the past, has issued such notices to Cipla and Ranbaxy.
crackcrackCompany Name | CMP |
---|---|
Sun Pharma Inds. | 1786.85 |
Dr. Reddys Lab | 1173.55 |
Cipla | 1525.50 |
Lupin | 2018.35 |
Zydus Lifesciences | 859.10 |
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