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By PharmaCompass
2019-10-10
Impressions: 3139
India’s leading generic drug manufacturers continue to be in the news for regulatory concerns regarding the state of their manufacturing compliance.
Last week, after the US Food and Drug Administration (FDA) issued a warning letter to Lupin’s Mandideep facility, there was news that Glenmark Pharmaceuticals has received a warning letter from the US agency for their facility in Baddi in Himachal Pradesh.
The regulatory concerns and actions being taken repeatedly by regulatory agencies only go on to reiterate that there are wide gaps in the manufacturing practices being adopted by some of the leading drug manufacturers of India.
Concerns over
anti-fungal product made by Glenmark
In the case of Glenmark, the inspection conducted by the FDA between April 15, 2019 and April 20, 2019 was initially classified as an ‘Official Action Indicated’ (OAI). This meant the facility was considered to be in an unacceptable state of compliance with regard to current good manufacturing practice (cGMP).
Following the inspection, Glenmark recalled 31,000 tubes of an anti-fungal product from the US market, which had been manufactured at the Baddi facility, due to “temperature abuse” and complaints received due to the liquid texture of the product.
It seems the actions taken by Glenmark failed to address the US agency’s concerns and the FDA went on to issue a warning letter to the Baddi facility.
Glenmark’s filing states that it does not believe the warning letter will interrupt manufacturing or sales from the facility, which contributes US$ 30 million in total sales for the company. This makes up for about 7 percent of its US sales.
The news comes a few months after manufacturing concerns derailed Glenmark’s plans to get an approval for the New Drug Application of Ryaltris as the FDA cited deficiencies in the Drug Master File pertaining to one of the APIs used in the product. The agency also cited deficiencies at its manufacturing facilities.
Warning letter to Torrent: The FDA also issued a warning letter to Torrent Pharmaceuticals, another leading Indian generic drugmaker, for its largest manufacturing facility based in Indrad, Gujarat.
As has been the case with Lupin and Glenmark in the past, the inspection of Torrent’s facility in Indrad had been classified as OAI in August. And recently, more serious action was taken against it in the form of an FDA warning letter.
Concerns over data generated at Aurobindo
At Aurobindo, an inspection of its manufacturing facility in Telangana conducted last month — from September 19 to September 27 — raised concerns over the data generated at the site, leading its stock to plunge.
The Form 483 issued after the inspection shows that a review of the out of specification (OOS) investigations conducted by Aurobindo had revealed that the firm had invalidated over 90 percent of the OOS results related to product stability, raw materials and hold time studies.
In the case of one investigation, Aurobindo’s chemists simulated multiple hypothesis studies to confirm the cause of the OOS result. After reviewing the investigation, the FDA inspectors “were unable to determine if the hypothesis studies were actually conducted”.
In another case, a product complaint report was found to have been signed off with all associated tasks completed on or before September 14. However, a review of the electronic data revealed that the tasks were not completed until two days after the report had been authored (i.e. September 16).
The FDA also found multiple instances of production batch records that were unaccounted for. In one case, the Vice President of Quality provided a complete list of batches which had been made of a product. However, a review of the firm’s electronic record management system showed that additional batch records had been issued and executed.
The investigators also said the “documents requested were provided as incomplete, inaccurate, and/or explained with potentially misleading statements throughout the inspection”.
In addition, the reporting structure of the computer system administrator provided the FDA with “no confidence in maintaining the integrity of electronic data without potential conflict of interest”. The computer system administrator falls within the quality assurance department.
Compliance problems continue to mount at Aurobindo as earlier this year, Aurobindo’s active pharmaceutical ingredient (API) manufacturing facility in Hyderabad had received a warning letter a month after the FDA had classified three plants of the Indian drug major as OAI, necessitating regulatory and administrative action.
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Image Credit : Compliance Concerns in India by PharmaCompass is licensed under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
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