Canadian importers to quarantine products from DRL, IPCA facilities

Action applies to active pharmaceutical ingredients from DRL as well as to finished drug products from a different IPCA Laboratories’ facility, Health Canada said.

December 24, 2014 11:52 pm | Updated 11:52 pm IST - HYDERABAD:

Canadian importers have decided to quarantine health products from Dr. Reddy’s Laboratories’ (DRL) unit in Srikakulam in Andhra Pradesh, as well as IPCA Laboratories’ Pithampur facility near Indore in Madhya Pradesh.

This follows regulator Health Canada’s request to them citing data integrity concerns at the two facilities. Their decision means they would stop import and distribution of the products. Health Canada said it made the request “in light of recent information from a trusted regulatory partner that raises concerns about the reliability of the laboratory data generated at these [two] sites.”

It is an interim precautionary measure to help mitigate any potential risk. “At this time there is no identified risk to health and Health Canada is not requesting a recall of any of the products,” the regulator said in a release available on its website.

The action applies to active pharmaceutical ingredients (APIs) from DRL as well as to finished drug products from a different IPCA Laboratories’ facility, Health Canada said. Last month, DRL had received inspectional observations from the US FDA, after a team visited the API facility in Srikakulam.

On Wednesday, a DRL spokesperson said the company had submitted its response to the USFDA within the set timeline.

Regarding the action of Health Canada, the spokesperson said the company had “voluntarily placed under observation all the APIs and formulation, meant for Canada, at the Srikakulam unit.

“They have been kept under observation,” she said, when asked to elaborate, adding production for other markets, however, was continuing as usual.

Sarabjit Kour Nangra, VP (Research-Pharma) of Angel Broking, said both companies “do not derive significant revenues from these facilities.”

0 / 0
Sign in to unlock member-only benefits!
  • Access 10 free stories every month
  • Save stories to read later
  • Access to comment on every story
  • Sign-up/manage your newsletter subscriptions with a single click
  • Get notified by email for early access to discounts & offers on our products
Sign in

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 The Hindu 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.