Asia Regulatory Roundup: Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist (15 November 2016)

Regulatory NewsRegulatory News | 15 November 2016 |  By 

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

TGA Prepares Changes to Advertising Complaints Process

The Therapeutic Goods Administration (TGA) of Australia is seeking industry feedback on the reform of the advertising complaints management process. TGA is considering either setting up a centralized process for handling complaints or outsourcing some or all of the work to an independent authority and wants to get the industry’s take before pushing ahead.

Currently, complaints about advertising are addressed to different panels depending on the medium of promotion. For example, complaints about leaflets are heard by a different panel than complaints about adverts in magazines. A review into drug and device regulation found fault with this approach. Healthcare providers cited the confusing, opaque and slow nature of the current process as reasons for reform. The penalties possible under the existing approach are seen as being ineffective, too. This prompted the review to recommend the overhaul of the system.

The recommendation suggested a single agency should handle complaints, but gave the government flexibility in how it realized the proposal. One option given by reviewers was to put TGA or another government agency in charge of complaint management. The other was to put the work out to tender. This second approach would lead to an independent, nongovernmental organization handling the task. The review gave no indication as to which option was preferred by the authors of the report.

TGA has taken the reviewers’ brief and put forward three models for assessment by the industry. The first option is for TGA to take full control of the work. The regulator doubts any other government agency has the necessary expertise to take on the job, and therefore has put itself forward as the only internal candidate to manage the process. TGA thinks it could remedy many of the concerns raised in the review if given control of the complaints process. However, it is concerned companies will see the model as giving TGA a role traditionally shared with the industry. 

One alternative model is to contract an independent group and give it statutory powers to receive, investigate and determine complaints. The power to enforce compliance and take punitive actions could reside with either TGA or the independent body.  The regulator has some concerns with this approach. For an independent body to rule whether a claim is misleading, it would need comparable expertise to TGA, leading to duplicated capabilities. One workaround would be for TGA to be an expert advisor, but the regulator sees cost and complexity problems with this approach.

TGA is proposing a third model in which it receives all complaints and outsources those that are less serious or unrelated to therapeutic claims to an independent organization. This is seen as allowing TGA to focus its resources on major cases, but could also create delays.

The consultation is open until 21 December.

TGA Consultation

DCGI Promotes WhatsApp Channel to Resolve Drug Shortage

The Drug Controller General India (DCGI) has promoted Panacea Biotec’s use of a WhatsApp channel to resolve a drug shortage. Panacea set up the channel on the Facebook-owned messaging platform to connect patients and doctors affected by the penicillamine shortage to its executives.

DCGI GN Singh alerted the public and his regulatory colleagues to the initiative in a letter published on the Central Drugs Standard Control Organisation’s (CDSCO) website this week. The channel is one of several outreach programs initiated by Panacea since it stepped up its response to the shortage. Panacea also has a Twitter handle, Facebook page and website dedicated to informing patients and doctors about the availability of its formulation of the rare disease drug penicillamine.

Singh is telling anyone affected by the penicillamine shortage to contact Panacea through one of the communication channels set up by the company. The issuing of advice continues the active role Singh and his colleagues have played in the shortage over the past two months. Panacea was one of five companies Indian regulators called to a meeting late in September. The meeting was scheduled after officials learned penicillamine had “disappeared from the market.”

Since then, Singh has pressured local manufacturer Fleming Laboratories to increase its output of the active pharmaceutical ingredient penicillamine to offset the disruption of supply from China.     

DCGI Letter

Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist

The Drug Administration of Vietnam has added Aurobindo Pharma and five other Indian companies to the blacklist it uses to keep track of drugmakers that violate quality standards. Aurobindo is one of 39 Indian companies on the latest version of the list.

The notice is light on details of what Aurobindo, Brawn Laboratories, Macleods Pharmaceuticals, Prayash Healthcare, Vintanova Pharma and Zee Laboratories did to land themselves on the blacklist. The six Indian drugmakers are joined on the latest batch of new additions to the blacklist by Il Dong Pharmaceuticals of Korea and Nexus Pharma of Pakistan. Indian drugmakers now account for three-quarters of the companies on the blacklist.

That proportion was affected slightly by the companies the regulator removed from the list in the latest update. India’s Umedica Laboratories and Zim Laboratories are no longer on the blacklist. Bangladesh’s Globe Pharmaceuticals and Korea’s Dae Han New Pharm were also removed this week. The regulator also reviewed the cases of three other companies — two Indian, one Korean — but left them on the blacklist. 

The update brought no changes to the status of the few Western drugmakers on the list. Vietnamese regulators last provided an update on the status of Apotex, ADH Health Products and Robinson Pharma — the three North American companies on the list — in 2014.  

Regulatory Update(Vietnamese)

CFDA Trials Data Reporting Platform for Narcotics, Precursor Chemicals

China Food and Drug Administration (CFDA) is set to trial a data reporting platform for organizations involved in the supply of narcotic drugs, precursor chemicals and other substances of interest to the authorities. The pilot project is set to begin at the start of next year.

CFDA has designed the platform to keep track of all substances that could be diverted into the supply chain for recreational drugs. Companies that work with such substances are already subject to an extra layer of regulations, and the platform would give authorities a more up to date look at their activities. CFDA expects companies to frequently add details of recent production runs, sales and other activities.

The regulator is now asking companies to register to use the platform. Pilot testing of the system is due to take place in Beijing, Hunan and Gansu next month. This phase is intended to enable CFDA to fix any problems before the nationwide trial of the platform begins on 1 January. CFDA wants users of the system to provide feedback on problems or potential improvements by the end of March, after which it will tweak the platform as needed.

CFDA Circular (Chinese)

Other News:

Regulators in India have put imports from China on their radar. The focus on China follows analyses that showed most substandard drugs that enter India come from China. An anonymous official at the DCGI’s office said this has prompted a shift in strategy. Officials are using an electronic system to check the documentation of imported drugs and the veracity of their labels. The Economic Times

Torrent Pharmaceuticals has claimed substandard products purporting to be manufactured at its plant were counterfeits made elsewhere. The Economic Times


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