Asia Regulatory Roundup: India Creates Compensation Application Form for People Affected by J&J Implants

Regulatory NewsRegulatory News | 25 September 2018 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Pushes Ahead With Efficacy Claimer Labels Despite Mixed Response
Australia’s Therapeutic Goods Administration (TGA) is going ahead with plans to allow the addition of an efficacy claim to the labels of certain nonprescription products. TGA committed to implementing the idea despite it receiving a frosty reception from producers of over-the-counter (OTC) medicines.
The idea of adding efficacy claims to the labels of certain complementary products emerged in response to work on the assessed listed pathway. As products that follow this pathway must undergo pre-market efficacy assessments, TGA proposed allowing manufacturers to use label claims to differentiate their merchandise from rivals that follow less rigorous pathways. Branded drugmakers including Pfizer and Sanofi have attacked the proposal. 
TGA’s claimer proposal began receiving criticism during a consultation on complementary medicine reform last year, and was attacked again during a more targeted consultation that began in May. The respondents warned that applying claimers to complementary medicines could create the impression that these products had been more rigorously assessed than prescription and OTC drugs. Yet, with consumers, healthcare professionals and the complementary medicines industry supporting the idea, TGA has gone against the wishes of prescription and OTC medicine manufacturers.
“We considered the OTC sector's concerns about the potential impacts of the claimer for OTC products. However, we note that complementary medicines are generally separated from OTC products in the retail outlets where they are purchased and furthermore, that there does not appear to be a significant overlap between the therapeutic uses for OTC and complementary medicines,” TGA wrote in its response to the latest feedback.
TGA’s downplaying of the concerns of the OTC industry led it to allow manufacturers of assessed listed medicines and registered complementary medicines to display efficacy claimers.
The agency took the other concerns of OTC manufacturers on board, though. With companies warning that allowing OTC medicines to carry efficacy claimers would complicate efforts to globally harmonize product labels, TGA excluded registered OTC drugs from the products that can carry the labels. TGA will also run an education campaign designed to address concerns that consumers will perceive products with claimer labels to be more effective than registered OTC products.  
Consumer usability tests commissioned by TGA suggest the risk of confusion is real. Most of the surveyed people were unfamiliar with TGA and unsure about its assessment processes. The tests also suggested a symbol is the best way to alert consumers to an efficacy claim and found that people are confused by terms such as “efficacy.” That led TGA to settle on a “TGA assessed” claimer symbol and allow companies to add a simple statement to their product labels.
TGA Statement
India Creates Compensation Application Form for People Affected by J&J Implants
India’s Central Drugs Standard Control Organization (CDSCO) has created a compensation application form for people affected by Johnson & Johnson’s hip implants. The form is designed to help people on state- and national-level committees assess who is eligible to receive compensation.
In recent weeks, the Indian government has released a report into hip implants made by J&J’s DePuy Medical, set up compensation committees and asked people affected by the medical devices to come forward. Now, CDSCO has released a form to facilitate the efficient submission of patient information to the committees.
The form features boxes about basic patient information, such as name, address and occupation, sections that cover the details of the surgery they underwent and more detailed questions intended to flesh out the applicant’s medical history and interactions with J&J.
CDSCO wants to know if applicants have received any “medical management” or compensation from J&J or DePuy. Other questions seek to understand the impact complications related to the implants have had on the lives of applicants. CDSCO wants to know if applicants have lost jobs as a result of the complications and, if so, how much income they were deprived of as a result.
Compensation Form
TGA Proposes Restricting Pediatric Use of Anesthetic Benzocaine
TGA has proposed prohibiting the use of most topical oral forms of the anesthetic benzocaine in children under two years of age. If the changes are adopted, lozenges will be the only topical oral preparation of the anesthetic cleared for use in the pediatric population.
Australian officials are planning to revise the required medicine label advisory statement for the drug in response to a warning from the United States Food and Drug Administration (FDA). Writing in May, FDA warned against using OTC oral products containing benzocaine to treat teething pain. FDA found the products have little effect on pain and raise the risk of methemoglobinemia, a potentially fatal condition that occurs when oxygen-loaded hemoglobin accumulates.
In light of the significant risks posed by OTC oral benzocaine products, FDA urged manufacturers to stop selling them and warned it would take action against companies that failed to comply. TGA does not need to take the same steps as FDA, as no benzocaine-containing teething products are on the market in Australia. TGA wants to make sure the market remains free of the products.
To achieve that goal, TGA is proposing to limit the use of benzocaine in infants to lozenges, which are themselves restricted by existing labeling requirements. The current requirements state benzocaine lozenges can only be used in children aged under six upon the recommendation of a doctor, pharmacist or dentist.
TGA is accepting feedback on the proposed changes until 16 October. Beyond that, TGA has penciled in the publication of the final changes for January 2019. Manufacturers would then have 18 months to update their labels.
TGA Consultation
India Moves Blood Product Filings Over to Online Regulatory Portal
CDSCO is set to stop accepting physical applications regarding the registration and import of blood products this week. From 26 September, companies seeking blood product clearances will need to use the online Sugam portal.
In expanding use of Sugam to new areas, CDSCO has typically allowed companies to choose between the online portal and paper filings for a period of time. This approach creates a staggered transition and gives companies a fallback option in case they have difficulties with Sugam. However, CDSCO is taking a different approach with blood products.
CDSCO will activate the blood product module of Sugam on 26 September and stop accepting paper filings the same day. The agency decided to make Sugam mandatory with immediate effect after meeting with industry representatives earlier this month.
The decision means the blood product industry will start realizing the purported benefits of Sugam as soon as possible. A recent report from the Comptroller and Auditor General (CAG) of India suggests the industry needs these benefits more than most. CAG found 32 of the 68 blood banks in the Delhi region lacked licenses “due to delay in processing applications for their renewal.”
As Sugam is supposed to make regulatory timelines shorter and more predictable, news of the move to the online portal has raised hopes that oversight of blood product organizations will improve.
“Any move to streamline the blood banking system and expedite licensing is a welcome step, as many of these firms are currently functioning without proper approvals,” a health professional associated with the Indian Red Cross Society told Pharmabiz last month.
DCGI Notice, CAG Report, Pharmabiz


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