Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

TGA Seeks Feedback on Changes to Oversight of Low-Risk OTC Products

The Therapeutic Goods Administration (TGA) of Australia has put forward proposed changes to the regulation of low-risk products for consultation. TGA is seeking feedback on whether it should free some over-the-counter (OTC) medicines from the need to go through premarket assessments.

Currently, TGA classes products such as antiseptic first aid treatments, some laxatives and benzoyl peroxide-based acne drugs as registered non-prescription medicines. This status is placed on OTC products that contain active ingredients that are either found in the Australian Poisons Standard or are prohibited for use in listed medicines. Listed medicines only undergo sponsor self-assessment before going on sale, whereas producers of registered OTC products must complete a premarket review of safety and efficacy data and comply with good manufacturing practices.     

TGA is debating whether this is too heavy-handed an approach to regulating OTC products with a long history of safe use. This thought was planted by the Expert Panel Review of Medicines and Medical Devices Regulation, which said some low-risk products and devices should be governed by other regulatory frameworks or treated with a lighter-touch approach within the existing system. The government accepted the recommendations, leading to TGA drafting proposals for consultation.

For OTC medicines, TGA has put forward two options. One option is to maintain the status quo. TGA thinks the current approach fosters a high level of consumer confidence in OTC medicines, but acknowledges it may be driving up costs and extending time to market through over regulation. As such, TGA has also put forward option two. This proposal calls for a review of the safety of active ingredients to identify low-risk OTC products that could move to the self-assessed, listed regulatory framework. TGA thinks this could lower the cost of these products.

The regulator is seeking feedback on which, if any, option people prefer and whether some OTC products definitely should — or should not —  be reviewed with a view to adding them to the listed category. TGA wants people to comment on the impact of the two options on public health, market access and business operations. The agency is also open to hearing alternative proposals.

TGA included the options in a consultation document that shows the breadth of products classed as low risk. The agency has put forward different, typically more liberal options for other classes of OTC products, including diaper rash cream, antiperspirants, hard-surface disinfectants, sunscreens and tampons.

The draft is open for comment until 12 May.

TGA Consultation

CDSCO to Gather Evidence of Illegal Production, Importation of Oxytocin

The Drug Controller General of India (DCGI) has ordered regional regulatory offices to set up ways of collecting complaints about the illegal importation and production of oxytocin. DCGI Dr. GN Singh made the request to tighten regulatory control over the manufacture, sale and distribution of the hormone.

Singh wants zonal, sub-zonal and port offices of the Central Drugs Standard Control Organization (CDSCO) to create mechanisms for collecting complaints. CDSCO staff could use email addresses or physical complaint boxes at their offices to gather the comments. Whatever approach is taken, the idea is to ensure the public can alert CDSCO offices to evidence oxytocin is being illegally made or imported. Singh also wants CDSCO officials to collect evidence of misuse of the hormone.

The request follows a meeting convened by Ministry of Health officials last month. At the meeting, government officials discussed how to restrict and regulate the production of the human peptide hormone. India banned the retail sale of oxytocin by pharmacies in 2014 to curb its misuse by farmers, some of whom used it to boost the milk production of their cattle or to increase the size of fruits and vegetables. Despite this action, misuse continues.

With the High Court of Himachal Pradesh permitting production of oxytocin and reports of misuse continuing to accrue, DCGI wants CDSCO offices to step up their oversight of the product. DCGI expects each office to send a report about oxytocin complaints in their jurisdiction to the headquarters of CDSCO every month. Officials hope this will lead to regulatory actions that curb misuse.

Oxytocin is used, or misused, to accelerate childbirth. A survey of 99 women who gave birth in rural India from 2007 to 2009 found more than three-quarters of them received oxytocin. Use in healthcare facilities was lower. The hormone typically makes the headlines for its role in farming, though. Singh sent a letter to state drug controllers calling for actions to tackle veterinary misuse following the implementation of restrictions on the sale of oxytocin in 2014.  

DCGI Memo, Survey, Letter

Australia Considers Relaxing Ban on Advertising of Pharmacist-Only Medicines

TGA is proposing to relax its ban on the advertising of pharmacist-only medicines. The regulatory rethink could free manufacturers of schedule 3 drugs to engage in direct-to-consumer advertising in Australia.

Officials at the regulator are yet to flesh out how they plan to proceed, but are reviewing the topic at the recommendation of the Expert Panel Review of Medicines and Medical Devices Regulation. TGA’s uncertainty about the best strategy stems, in part, from the diversity of opinions on the topic that emerged when the industry was consulted in 2015 and 2016. Those consultations showed a minority of people favor completely lifting the ban, but most prefer a more nuanced approach.

Faced with the lack of a widely accepted model, TGA has released the suggestions it received during the previous consultations to gauge whether any of them find favor with the sector. One option is to create criteria substances must meet before being included in the TGA advertising framework. Another is to build on the existing appendix H list that today permits the advertising of 16 schedule 3 ingredients. Alternatively, TGA may make advertising requests part of approval filings.  

TGA put forward the ideas in a document that also covered planned reforms of the scheduling policy framework. The consultation addresses the timing of scheduling decisions, tools for better managing rescheduled medicines and other topics.

The document is open for consultation until 28 April.

TGA Consultation

Pakistan Pressures Manufacturers to use Pharmaceutical-Grade Packaging

The Drug Regulatory Authority of Pakistan (DRAP) is pressuring manufacturers to use packaging that meets pharmaceutical standards. DRAP ordered manufacturers to comply with regulations on the topic after its registration board deemed the rules “essential” to product quality. 

Members of the registration board discussed the topic in late December. DRAP has since written to trade groups to say attendees concluded “use of pharmaceutical grade container closure system is essential as it affects quality of the finished pharmaceutical product.” As such, DRAP wants to reinforce the message that packaging materials must be of pharmaceutical grade.

When there is no monograph in a pharmacopoeial reference book, DRAP is advising manufacturers to follow World Health Organization standards.

DRAP Circular

Other News:

DCGI Singh has requested feedback from regulators and trade groups on how officials should update schedule H. The schedule is one classification for prescription drugs sold in India. Officials last updated the list of schedule products in 2006. Now, after a trade group noted the lack of topical corticosteroids on the schedule, DCGI has asked for suggestions about which products to add or delete from the list. DCGI Notice