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Asia Regulatory Roundup: India to Add EU to List of Regions Covered by Clinical Trial Waiver

Posted 20 August 2019 | By Nick Paul Taylor 

Asia Regulatory Roundup: India to Add EU to List of Regions Covered by Clinical Trial Waiver

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
India Seeks Feedback on Mandatory use of QR Codes on API Packaging
 
India is planning to require manufacturers to feature quick response (QR) codes on the packaging of locally made and imported active pharmaceutical ingredients (API). The Indian government plans to implement the system at the start of April.
 
Through an amendment to the Drugs and Cosmetics Rules, 1945, the Indian government wants to mandate the use of QR codes on each level of packaging. The codes will store information intended to facilitate the tracking and tracing of packs of API across the supply chain. At a minimum, officials expect the codes to store 11 pieces of information.
 
The proposed list of minimum data requirements includes a unique product identification code, the name of the API, details of the manufacturer and information about the ingredient, such as its batch number and the date it was made.
 
In parallel to putting the required legislation in place, the Indian government is working to establish the technological infrastructure needed to make the system work. The Centre for Development of Advanced Computing, which was involved with India’s Sugam online regulatory portal, is in charge of setting up an online system for tracing and authenticating API shipments.
 
If passed, the legislation would place additional regulatory requirements on companies that want to sell APIs in India. Separately, the government is working to lessen reliance on API imports, most of which come from companies based in China.
 
The Indian government is accepting feedback on the QR code proposal for 30 days.
 
Gazette Notification
 
TGA’s UDI Proposal Gets Broad Industry Support
 
The medtech industry has voiced broad support for the Therapeutic Goods Administration’s (TGA) plans to adopt a unique device identifier (UDI) system in Australia. Trade groups and manufacturers backed the broad outline of the plan, while raising concerns about some of the details.
 
TGA exited the consultation with industry support for the introduction of a UDI system in Australia, leading the agency to outline plans to develop the legislative amendments needed to turn the idea into a reality. The feedback received during the consultation will inform those legislative activities, although TGA is yet to provide details of exactly what effect the comments had on its thinking.
 
Even so, the TGA consultation document and industry responses to it provide an overview of how the agency is likely to proceed. Respondents welcomed TGA’s plan to base its UDI system on guidelines in development at the International Medical Device Regulators Forum.
 
Most of the respondents also advocated for TGA to handle the creation and management of the UDI database, known as AusUDID. Boeheringer Ingelheim was among the organizations to make the case for TGA handling the work itself.
 
“There is no concern with the TGA establishing and managing the AusUDID. This is similar to the European Union and USFDA managing their own databases,” the company wrote. “Disadvantages of other organizations establishing and managing the AusUDID include data safety, data security and information protection.”
 
Boehringer and some other organizations also backed TGA’s proposal to take a risk-based approach to the transition to UDI and align itself with the European Union timelines. However, TGA also received pushback on that proposal, including from MedTech Europe.
 
“Aligning the transitional timeframe for UDI labelling/marking compliance with the EU transitional times may not be appropriate due to the different timelines for the Eudamed and the AusUDID. For database milestones, it will only be appropriate to align with the EU if the AusUDID is available and validated on the same timeline as the Eudamed UDID,” the trade group wrote.
 
TGA is yet to share a timeline for the next steps in the development of the UDI system. If it sticks with its plan to align with the EU transitional timelines, TGA will start requiring Class III and implantable devices to carry UDIs in May 2021 and enforce the rules for lower-risk products in stages through to 2027.
 
Consultation Responses
 
India to Add EU to List of Regions Covered by Clinical Trial Waiver
 
India is planning to add the European Union to the list of regions covered by its clinical trial waiver rule. The change will free companies from the need to run clinical trials of medical devices that are already available in the EU when they want to access the Indian market.
 
In the Medical Device Rules, 2017, Indian legislators agreed to waive the need for clinical trials when a device is “approved by the regulatory authorities of either the United Kingdom or the United States of America or Australia or Canada or Japan and the said device has been marketed for at least two years in that country.” The EU is the notable omission from that list.
 
Representatives of the EU pointed out the omission at a meeting of the India-EU subcommission on trade in 2018, leading to the matter being referred to the Drugs Technical Advisory Board (DTAB). In meeting minutes published this week, DTAB agreed to change the rules to include the EU.
 
The change was one of a clutch of recommendations made by DTAB at the meeting. DTAB also looked at good distribution practices (GDPs), a subject it has considered several times in the past. The focus on GDPs reflects a concern that the current Indian rules enable unauthorized entities to distribute and sell medicines, leading to the introduction of spurious drugs into the legal supply chain.
 
Faced with that problem, DTAB thinks Indian legislators should make provisions for GDPs in the Drugs and Cosmetics Rules, 1945. The recommendation follows a request for feedback on draft GDP guidelines.
 
Meeting Minutes
 
TGA Hits More Sellers of Selective Androgen Receptor Modulators With Notices
 
TGA has issued two more advertising directions notices to sellers of selective androgen receptor modulators (SARMs), a type of performance-enhancing drug. The agency has targeted promotions of the Schedule 4 products since taking over the handling of advertising complaints in Australia.
 
In its brief history of handling complaints, TGA has told four organizations to stop running ads. Three of those TGA notices, the only ones issued by the agency this year, relate partly or exclusively to SARMs.
 
Auzsupps and ESR You are the latest two organizations to receive TGA notices about the promotion of SARMs. TGA told ESR You to stop advertising SARMs and other products on various websites, including Facebook and Instagram, after a complaint led it to information it thinks violates the ban on the promotion of Schedule 4 products.
 
The promotional materials cited in the TGA notice link SARMs to outcomes including more muscle mass, increased libido and accelerated healing and joint repair. As the products are represented as therapeutic goods, TGA asked ESR You to take down the ads in May. However, at the time of TGA’s latest action, ESR You had yet to made the requested changes.
 
Auzsupps did make changes in response to TGA’s original request. However, the agency found, “The website still contains a range of advertisements featuring products which contain substances included in Schedule 4 to the current Poisons Standard,” leading it to issue the advertising direction notice.
 
TGA Notices
 
Other News:
 
TGA has outlined plans to crack down on the non-compliant advertising of bioresonance devices. The devices are marketed on the grounds that they detect illness by measuring electromagnetic waves emitted by the body. TGA Notice
 
CDSCO’s deputy drug controller Naresh Sharma was arrested on 16 August on corruption charges. Economic Times
 

Tags: API, CDSCO, TGA, UDI

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