Comments
Pharma major Dr Reddy’s Laboratories Ltd appears to be in serious trouble as the US Food and Drug Administration (US FDA) has raised serious concerns about some of the practices being followed by the company.
It may be recalled that on November 5, the US regulator had issued a warning letter to the Hyderabad-based company on its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as an oncology formulation manufacturing facility at Duvvada, Visakhapatnam, AP.
While Dr Reddy’s had announced that it will send a response to the FDA, the alleged violations appear to be of significance with a possibility of pushing the company into further trouble.
For instance, the FDA has specifically mentioned that the company did not put in place a system for ensuring data protection as its systems were not protected by any administrator’s password.
It also questioned the lack of corrective action for those testing results that were found to be out of specific nature as well as prevention of microbial infections.
Corrective actions “These items, as well as other deficiencies our investigators found, lead us to question the effectiveness of your current corporate quality system to achieve overall compliance with CGMP,’’ the regulator said in the letter addressed to Dr Reddy’s Chairman K Satish Reddy.
A suggestive list of corrective actions included contacting customers, recalling product (s), conducting additional testing, adding lots to stability programs to assure stability, monitoring complaints, revising procedures, implementing new controls and training or re-training personnel.
The time given for Dr Reddy’s to respond with corrective actions had expired on November 20, 2015, and it now remains to be seen how the issues are addressed.
The company faces the prospect of losing product approvals from the facilities under question.
The US FDA action follows the earlier inspections of these sites by the agency in November 2014, January 2015 and February 2015, respectively.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.