The Indian pharmaceutical industry cannot seem to shake off its difficult performance trend during international regulatory inspections. Generic majors Lupin and Zydus Cadila are the latest in the list of companies, who have had serious GMP deficiencies uncovered during recent inspections.
How much will this impact the industry?
Update on Dr Reddy’s Srikakulam observations
In one of our recent assessments, we had analyzed why “Dr. Reddy’s largest API facility maybe the next to get banned from exporting to the United States”.
Quality Executive Partners Inc, a boutique consultancy firm, which specializes in providing executive level talent, recently posted the redacted Form 483 issued to Dr. Reddy’s.
The observations listed on the form, highlight concerns, which had not previously been reported. Dr. Reddy’s not only failed to mention the presence of an analytical laboratory, which was “only discovered” later, they deleted analytical raw data and the inspectors found many original documents in the company’s waste area.
Multiple instances where samples were failing specifications and reported as passing have also been cited.
Serious concerns at Zydus Cadila
Quality Executive Partners Inc, also posted the redacted Form 483 issued to Cadila Healthcare’s Zyfine unit (also known as Zydus Cadila), which was inspected by the U.S. FDA in December 2014. The facility, located in Ahmedabad, India, had a series of glaring data-integrity observations, which ranged from:
- Records were not made readily available during the inspection; the Vice President, Corporate QA stated that the requested document was located at an employee’s home.
- During the FDA walk through the inspectors found five original and rewritten records, which were falsified.
- Inspectors found rough notebooks in the scrap yard as well as the engineering and QA offices.
- Documents were signed and dated by individuals who were not present at the site.
- Reprocessing was performed without review and approval of the quality unit.
- Batch records were not reviewed by production and QA personnel before release.
- Washing and toilet facilities lacked soap.
Could this inspection be the reason Zydus appointed a new President of Corporate Quality in December?
Lupin’s Brazilian dreams hit a bump
Lupin’s Latin America expansion plans hit a bump recently, when the Brazilian Health Agency (ANVISA) suspended imports of certain products from their Mandideep plant due to GMP concerns found, during an ANVISA inspection.
It was less than two weeks ago, when Lupin announced their first major Brazilian foray, an acquisition of Medquimica Industria Farmaceutica S.A. for an estimated $100 million.
The Brazilian pharmaceutical market, the sixth largest in the world and growing at a compounded rate of 17% is part of Lupin’s Latin America strategy, which also had them acquire Mexico’s Laboratorios Grin last year.
While the ANVISA resolution does not list in detail the problems found, ANVISA has recommended the suspension of import of all beta-lactam cephalosporins, and all drugs which have been produced with these products from the Mandideep plant.
Lupin’s 2014 annual report states that the cephalosporin business contributed 47% of the revenues to their API portfolio.
Since Brazil’s ANVISA and Mexico’s regulatory agency, COFEPRIS (Federal Commission for the Protection against Sanitary Risk), share a high level of mutual cooperation (e.g. outcome of certain inspections by one authority are recognized by the other), the impact of the Mandideep inspection on Lupin’s Latin American dreams remains to be seen.
Our view:
Failure in international regulatory inspections is continuously tarnishing India’s reputation as a producer of high quality, low cost medicines. Especially as lots of these concerns can be avoided so easily (see our previous compilation of 'Where companies who fail EDQM inspections go wrong.')
However, while bad news travels fast, India still maintains a more than 90% success rate in international regulatory inspections.
In order to preserve the 'Made in India' image, Indian companies need to avoid what is easily avoidable and continuously communicate and broadcast their inspection successes.
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Image Credit : CHAINED! by Vinoth Chandar is licensed under CC BY 2.0
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