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Reine Lifescience gets US FDA warning letter for flouting cGMP norms for APIs; second Gujarat firm to face heat this year
Arun Sreenivasan, New Delhi | Monday, May 21, 2018, 08:00 Hrs  [IST]

Just a few weeks after finding deficiencies at the production plant of a Gujarat-based drug maker, another pharamaceutical company in the state, this time a leading active pharmaceutical ingredient (API) manufacturer, has come under fire from the US Food and Drug Administration (FDA). The US federal agency has issued a warning letter to Reine Lifescience, the first cautionary note to an Indian firm in May, and put the company on import alert after finding ‘significant deviations’ from current good manufacturing practice (cGMP) norms for APIs.

The Ankleshwar-based Reine Lifescience is specialised in the manufacturing and development of a wide range of bulk drugs and its advanced intermediates. Its product portfolio includes APIs such as atorvastatin calcium, pregabalin IP and bumadizone calcium hemihydrates. In April, the US FDA had pulled up Goran Pharma, another Gujarat-based company that manufactured oral care and pain relief products, over serious violations of cGMP tenets.

API is a drug’s central and chemically active ingredient that produces the intended therapeutic effect on a patient. According to official figures, India imports about 84 per cent of the APIs it needs and a major portion of it comes from China.

The FDA officials, who inspected Reine’s manufacturing facility in the GIDC Industrial Estate from October 30 to November 3 last year, observed that the company failed to validate and verify the suitability of analytical methods. The analytical data was in a folder named PD Trial. While the folder was normally intended for product development, PD Trial folder contained batch data for API and results appeared to differ significantly from recorded test results.

In its response, the company had committed to completing method validation and performing an impact assessment for commercially distributed batches by February 2018. But the FDA found the action inadequate as the firm did not provide updated procedures that would implement use of only validated methods for testing future batches of API intended for the US supply chain.

The FDA also noticed failure to exercise sufficient controls over computerised systems to prevent unauthorised access or changes to data, and failure to have adequate measures to prevent omission of data.

“Our investigator observed that the audit trail feature was disabled on instruments you use for quality control testing of your API, including your high performance liquid chromatography system. Your analytical systems also lacked controls to prevent users from deleting or altering electronic data. For example, your quality assurance executive, who also performed your analytical tests, had administrator access to each system,” the FDA stated in its warning letter to the company.

The US agency found fault with Reine’s written procedures for the cleaning and maintenance of equipment to curb cross contamination. According to the US FDA, the Indian pharma manufacturer “released and shipped APIs to the US market that were manufactured using multi-product equipment before completing equipment cleaning validation”. The FDA placed the firm on import alert. The authority is expected to withhold approval of any new applications or supplements listing Reine as a drug manufacturer until all deviations are corrected. Failure to correct the deviations may also result in the authority continuing to refuse admission of articles manufactured at the Reine plant into the US market.

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