Indian pharma is now gearing up to comply with the Australian Therapeutic Goods Administration (TGA) latest guidance enforced from January 15, 2018. The new Uniform Recall Procedure for Therapeutic Goods (URPTG) provides a consistent approach for undertaking recall and non-recall actions of therapeutic goods supplied, imported into or exported from Australia. It replaces the Uniform Recall Procedure for Therapeutic Goods (2004) following public consultation.
While the fundamentals for undertaking a recall or non-recall action remains the same, the new procedure introduces some changes, such as new types of recall and non-recall actions.
According to Kaushik Desai, Hon. Secretary, Indian Pharmaceutical Association and pharma consultant, the regulation is applicable for Indian exports and imports and these norms are in sync with the current requirements of international marketing. Drug recall needs a set of rules and the withdrawing from the locations. This procedure is applicable for exports and imports. All Indian companies will now have to follow this procedure.
The updated version after 14 years makes it more simplified and consistent. However, it is an elaborate procedure of 81 pages. India has a number of TGA approved plants. In fact all the USFDA and EU audited facilities are TGA endorsed production units, added Desai.
The market in Australia is small but significant for Indian pharma. Moreover, TGA approval is the first audit taken by most Indian companies and puts a system in place for clearances from international regulatory agencies like the US FDA and the EMA, said Desai.
Now this URPTG outlines the non-recall actions which is introduced for the first time. This will bring in transparency and uniformity with the global requirements, stated Desai.
According to TGA, the purpose of the new regulation is to assist the sponsor to conduct recalls and non-recall actions using a standardised systematic procedure. It enables sponsors to respond efficiently and effectively to issues with a therapeutic good that has or may pose a risk to public health and safety.
This procedure is also applicable when the TGA orders an appropriate responsible entity to conduct a mandatory recall. Civil and criminal penalties apply if you do not comply with a mandatory recall, stated the guidance.
Not all issues require recall actions. A company undertake a non-recall action if the therapeutic goods meet all specifications and standards and there are no deficiencies in safety, quality, efficacy, performance or presentation.
More over the supply chain can identify an issue that requires either a recall or non-recall action. It could be through the manufacturer through the implementation of their Quality Management System or an Australian sponsor through adverse event reports or complaints or even through TGA its through post-market monitoring and compliance activities. Further, it could also be through even other regulators, who notify TGA through international collaborative activities and Third party audits or inspections by other regulators.
The Australian regulator further noted in its guidance that it would encourage sponsors to follow this procedure to decide, in consultation with them, to take the most appropriate action which is recall or non-recall to mitigate an actual or potential public health risk from a particular drug or device. There are immediate recalls, other recalls, product tampering and non recall actions. In other recalls there should be a risk assessment and need to obtain distribution and stock status.
Source : www.pharmabiz.com
Published on: January 24, 2018