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Editor's Note: For those of you who don’t regularly watch CNBC’s India affiliate, you may have missed PharmAsia News' own Vikas Dandekar on previous installments, but I thought I would forward the link to his interview this morning about the story he broke for PharmAsia News:
GMP Deviations Lead WHO To Issue "Notice Of Concern" To Matrix Labs; May Suspend Prequalified Anti-AIDS Products
Full story reprinted from PharmAsia News - July 24, 2009
MUMBAI - The Indian drug industry received another blow to its reputation when the World Health Organization issued a "Notice of Concern" to Hyderabad-based Matrix Labs, which is now 90 percent owned by Mylan, the third-largest generic drug maker in the world. Read the whole story...
GMP Deviations Lead WHO To Issue "Notice Of Concern" To Matrix Labs; May Suspend Prequalified Anti-AIDS Products
Full story reprinted from PharmAsia News - July 24, 2009
MUMBAI - The Indian drug industry received another blow to its reputation when the World Health Organization issued a "Notice of Concern" to Hyderabad-based Matrix Labs, which is now 90 percent owned by Mylan, the third-largest generic drug maker in the world.
WHO's first prequalification inspection covering the manufacture of Matrix Labs' anti-AIDS drugs was conducted May 26-28; since then, several rounds of communication have taken place between the international health agency and Matrix.
Large Indian generic drug companies like Ranbaxy, Cipla and Lupin are already undergoing close scrutiny by U.S. FDA on alleged lapses in production processes, falsification of data and documentation and charges of inept handling of pharmaceutical products (PharmAsia News, May 25, 2009).
Recently U.S. Marshals seized drugs produced by Caraco - majority owned by India's Sun Pharma - from one of Caraco's facilities in the U.S. (PharmAsia News, June 28, 2009).
In a formal written communication addressed to Matrix Labs, WHO officials stated: "The [Notice of Concern] procedure is performed and serious observations are made that result in concern about the site's compliance with specified standards such as those relating to Good Manufacturing Practices or Good Clinical Practices."
The world health body's inspection of the company's manufacturing facility revealed "major deviations from the WHO GMP standards," the letter said.
Among the listed deviations at the company's plant, which manufactures a host of anti-retroviral drugs, are failure to ensure appropriate control of recording of data and information in batch processing records and failure to ensure appropriate control over certain systems in some areas.
Sending out a stern signal, the agency stated: "It may consider suspension of the product(s) listed as prequalified from this manufacturing site, and/or may recommend suspension of procurement of prequalified products manufactured at this site."
When PharmAsia News contacted a spokesperson at Matrix Labs for clarification, she said she could not comment because the company had to comply with an international communication policy chalked out by Mylan.
According to an industry source familiar with the situation, the WHO has conducted similar prequalification investigations of a few other Indian manufacturing plants, and the possibility that more warnings could be issued to other companies cannot be ruled out.
- Vikas Dandekar
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