Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Australia’s TGA to Make Changes to Advertising Regulations
Australia’s Therapeutic Goods Administration (TGA) announced Tuesday that it will make a number of changes this month to its regulations around the advertising of therapeutic goods. Changes will be implemented over the next two years.
Specifically, the TGA said it will increase sanctions and penalties for advertisements that are noncompliant, amend its advertising code and complaints handling system as of 1 July and abolish the requirement for certain advertisements to be pre-approved, beginning 1 July 2020.
“In addition a formal education program including guidance materials will be developed and implemented to support advertisers,” TGA said.
NPPA Study Uncovers Triple-Digit Medical Device Margins
An analysis by India’s drug and device price watchdog has found producers of needles and syringes routinely add three-figure markups to their products. The trade margin analysis is reminiscent of the reviews the National Pharmaceutical Pricing Authority (NPPA) undertook before capping the price of cardiac stents and knee implants.
NPPA performed the review by gathering data from manufacturers and importers to support official records. The result is a comparison of the price to distributors and maximum retail prices of various types of hypodermic and insulin syringes.
For every type of device covered by the review, the average trade margin is at least 200%. Four devices have average trade margins of more than 600%. Those average figures hide some outliers. For a handful of devices, the maximum trade margin identified by NPPA tops 1,000%.
The findings have sparked calls for NPPA to cap prices. Some manufacturers of needles and syringes sought to deter NPPA from capping the prices of their products by voluntarily agreeing to cap margins at 75% late last year. However, with other companies opting against self-regulation, the move has reportedly had unintended consequences for firms that capped their margins.
“In the last month, we have lost accounts from as many as 50 hospitals because we decided to self-regulate,” an anonymous syringe manufacturer told The Economic Times
. “Some hospitals have told us that they will be switching to companies that can give better margins.”
NPPA referred to the self-regulation initiative last month when discussing the prices private hospitals charge patients for syringes and other pieces of medical equipment. The agency said some device manufacturers had asked it to intervene “in rationalizing the trade margins so that it is compulsorily compiled by all.” NPPA said it was “closely monitoring the developments” but revealed nothing about its willingness to intervene to address what it sees as “unethical profiteering in a failed market.”
The report on hospital margins was seen by some people as the trigger for the transfer of NPPA chairman Bhupendra Singh to another agency. The notice disclosing the syringe trade margins is dated 1 March, the day of Singh’s departure, but as is common with Indian regulatory releases was only made public several days later.
, The Economic Times
Australia Publishes Major Revision to Clinical Trial Handbook
The Therapeutic Goods Administration (TGA) of Australia has revised its guidance on running clinical trials. TGA’s revisions, its first major changes to the document since 2006, bring the text into line with the current regulatory environment and provide more detail about how to set up and run studies in Australia.
Version 2.0 of the guidance touches on all aspects of clinical trials, from broad basics such as the different phases, through to more advanced, Australia-specific aspects of getting a study approved. TGA hopes this will help sponsors, ethics committees, investigators and other groups understand their roles and obligations. The earlier document covered some of the same ground but in less detail, and aspects of its advice had been rendered obsolete by regulatory changes in Australia.
Among the wholly new parts of the document are sections on the advertising of experimental drugs and the retrieval and destruction of unapproved medicines. Other sections, such as a discussion of the merits of running trial extensions, are covered in more detail than previously. The changes have resulted in a document with 50% more pages than its predecessor.
In expanding the document, TGA has covered topics addressed in texts on access to unapproved drugs and human research ethics it published in the early to mid-2000s. Those documents, as well as the 2006 version of the clinical trial handbook, are superseded by the guidance released this week.
CDSCO Creates Public Relations Office to Handle Industry Grievances
The Central Drugs Standard Control Organization (CDSCO) has created a public relations office at its headquarters. CDSCO is setting up the office to act as a “single window” for redressing grievances, a task the agency has grappled with over the past year.
The agency sought to get its backlog of grievances under control last month by telling all senior officers to spend half their time addressing issues for one week. That done, CDSCO has decided it is best served by centralizing the grievance process so all new issues come into a public relations office that reports directly to the Drug Controller General of India.
Assistant drugs controller Sunil Kulshrestha will run the unit out of the reception of CDSCO offices in New Delhi with the support of a drug inspector and assistant drug inspector. People can take their grievances to the office during the work week without making an appointment. The unit will then seek information needed to resolve the issue from other units of CDSCO, which have been told by management to share whatever materials it needs.
CDSCO also wants the office to help people understand regulatory requirements related to their operations and otherwise support their activities.
Pakistan Posts Advert for Regulatory Chief as Scandal Engulfs Interim Leader
The Drug Regulatory Authority of Pakistan (DRAP) has begun recruiting a new chief executive officer. DRAP is without a leader following the retirement of its inaugural CEO and is embroiled in a scandal regarding its choice of interim successor.
Mohammed Aslam, DRAP’s inaugural CEO, retired at the start of last month when his three-year term came to an end. DRAP replaced Aslam with Sheikh Akhtar Hussain on an interim basis, only for legal challenges and an investigation by the National Accountability Bureau to mar the appointment.
The furor centers on allegations Hussain declared himself dead to dodge two corruption cases. Those allegations predate Hussain’s appointment but have received renewed attention in recent weeks. The interim appointment has also been criticized on the grounds Hussain occupied a lower rank in DRAP’s organizational structure than some of the officers overlooked for the temporary post.
DRAP’s tardy start to the search for a successor means Hussain could be in the temporary post for some time. Pakistani law requires DRAP to advertise for the CEO role in newspapers, but it was slow to comply. The advert went up on DRAP’s site last week, more than one month after Aslam retired.
In the advert, DRAP states it is seeking someone 45 to 56 years old with more than 20 years of experience in pharmaceutical management or regulatory affairs in the public sector. DRAP will only consider private sector candidates if no suitable person is identified in the public sphere. Aslam came from the private sector, a fact that made him a controversial choice in some quarters.
, The News
has approved and published a revised version of its product information form. The introduction of the new form follows amendments to the Therapeutic Goods Act 1989. TGA has updated the references to the act, provided additional instructions and tweaked the form to make it clearer. The changes amount to relatively minor updates to the form TGA adopted at the start of the year. TGA Notice
has issued a warning about a thermometer. The warning details ToLife Technologies’ decision to recall one lot of the Rite Aid Mini Digital Temple Touch Thermometer after learning the battery compartment is inadequately secured. TGA Notice