06.Are pain relief medications safe?
A large chunk of the analgesics we found on Australian shelves are made in India. It’s a country where pharmaceutical manufacturing has come under increasing scrutiny in recent times from the US Food and Drug Administration. In 2013, drug manufacturer Ranbaxy USA was found guilty of violating Good Manufacturing Practices (GMP – principles and procedures that ensure quality drug manufacture) as well as falsifying documents.
Painkillers aren’t tested by TGA laboratories prior to approving them for sale, but rather assessed for safety, quality and efficacy by the TGA based on companies’ self-reported data.
However, all the experts CHOICE spoke with said OTC pain relief medicines in Australia are well regulated, and that there’s no reason for concern about country of origin. If it’s got the AUST R number on it, which all over-the-counter painkillers such as paracetamol and ibuprofen are required to have, it means it’s been through a thorough regulation process by the TGA.
How is pain relief medication regulated?
Painkillers aren’t tested by TGA laboratories prior to approving them for sale, but rather assessed for safety, quality and efficacy by the TGA based on companies’ self-reported data. Drug manufacturers in Australia are also required to demonstrate compliance with GMP, which is usually done through an inspection.
Overseas drug manufacturers must also prove compliance with GMP with documentation, or occasionally an on-site inspection if documentary evidence can’t be provided. Based on the company’s documentation and in conjunction with advice from TGA experts, the TGA decides whether or not to approve the product.