Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
NPPA Ratchets up Pressure on Abbott, Medtronic to Keep Supplying Stents
The National Pharmaceutical Pricing Authority (NPPA) of India has stepped up its attempts to stop Abbott Healthcare and Medtronic from curbing supply of their high-end cardiac stents. NPPA’s latest move is to encourage hospitals, doctors and patients to tell it if there is a shortage of certain brands of stents.
The brands of cardiac stents targeted by NPPA make its intentions clear. In a memo to healthcare providers, patients, regulators and the industry, NPPA singles out two stents sold by Abbott, one manufactured by Medtronic and another produced by Boston Scientific as products of particular interest. The Abbott and Medtronic cardiac stents targeted by NPPA are the same brands the companies asked to pull from the market following the adoption of price controls earlier this year.
NPPA wants anyone with knowledge of supply shortages of these stents to contact it, either via telephone, WhatsApp or its online complaint platform. If a stent shortage is identified, NPPA will prioritize the issue and act to bring supplies of the Abbott, Boston Scientific or Medtronic product to the affected hospital.
The cost watchdog is also encouraging state drug controllers to perform checks to ensure hospitals and distributors have supplies of the stents. If necessary, NPPA wants the local regulatory officials to use powers provided by the Drugs (Prices Control) Order (DPCO), 2013 to inspect the offices of stent manufacturers, hospitals and distributors and “take necessary action.”
DPCO, 2013 allows regulatory inspectors to “enter and search any place” and seize any products or documents they suspect are involved in the violating of the drug pricing legislation. Inspectors can also “take all measures necessary for securing production of the drug ... in a court of law.”
The memo reiterates NPPA’s commitment to holding Abbott and Medtronic to the responsibilities it placed upon them earlier this year. Recognizing the potential for manufacturers to pull stents from the market following the imposition of a price cap, NPPA invoked powers to force companies to continue supplying their products for at least six months. NPPA cited this stipulation in its rejection of requests by Abbott and Medtronic to withdraw certain high-end stents from the market.
TGA Seeks Feedback on Plans to Broaden, Strengthen Punishment Powers
The Therapeutic Goods Administration (TGA) of Australia has detailed plans to bolster its powers to punish wrongdoing. TGA is seeking feedback on reforms that would enable it to seek injunctions to quickly stop serious cases of non-compliant advertising and enhance the sanctions it can impose on companies.
One aim of the proposed reforms is to empower TGA to act faster and more decisively against the most egregious and potentially harmful cases of noncompliance. TGA foresees using the injunctions to help clampdown on the advertising of “purported cancer cures or infant vaccines.”
TGA is also proposing to start issuing substantiation notices. These notices would require the recipient to provide information or documents to support a claim they made in an advert. TGA sees the notices acting as a preliminary investigative tool to help it establish whether a fuller probe is warranted. Companies and individuals who fail to respond within 21 days could face fines of up to AU$27,000 ($20,000) and AU$5,400, respectively. The fines for providing false information are almost twice as big.
Other proposed changes include the creation of powers to enable TGA to issue public notices. TGA would issue such notices when it has “reasonable grounds” to suspect an advert is noncompliant, is satisfied someone has or may suffer as the result of the promotion and thinks the regulatory action is in the public interest.
The start of the consultation marks the next step in a long-running reassessment of how Australia handles the regulation of advertising. Members of the expert panel convened by the government in 2014 proposed some of the ideas now on the cusp of coming into force. Last year, the government offered its response to the proposals and TGA held a consultation on the regulatory framework for advertising therapeutic goods. That consultation referred back to a 2013 review.
TGA to ban Advertising of Medicines Containing Codeine
TGA is to ban the advertising of medicines containing codeine from 1 February 2018. The change in the advertising policy is a consequence of the decision to reclassify codeine-containing medicines as prescription-only drugs.
Officials made the decision after almost two years of discussion, the publication of a 101-page on the safety and efficacy of codeine and the commissioning of an independent assessment of the regulatory, social and economic implications of reclassifying the active ingredient. The latest note from TGA focuses in on one of the regulatory implications manufacturers and pharmacists must deal with before the reclassification.
Companies can continue to advertise codeine-containing medicines until 31 January 2018. After that, medicines containing codeine will only be available on prescription and, as such, TGA regulations will restrict their promotion. TGA wants companies to prepare for this “well in advance” of the date of reclassification to ensure they do not inadvertently continue advertising medicines in print, online, on social media or in any other medium.
The change in status also affects pharmacists. TGA has told pharmacists to remove “product packaging, shelf, stand and floor advertising, dummy display products, website and social media material” by the deadline.
DCGI Extends Deadline for Implementation of Revised Medical Device Labelling
The Drug Controller General of India (DCGI) has extended the deadline for compliance with revised requirements for medical device labelling. DCGI Dr GN Singh’s decision means manufacturers can continue using stickers to show the date of manufacture and expiry of their devices until the end of the year.
Singh first allowed medical device manufacturers to use stickers to show the dates last year. That earlier action temporarily relaxed the rules on the labelling of medical devices to allow companies to comply with requirements through the use of stickers. With the temporary reprieve due to end later this month, manufacturers approached Singh to seek an extension.
The companies argued they needed more than the initially-allocated six months to adapt their labels to the date requirements. Singh has accepted this argument and is allowing companies to continue to use stickers to show the dates while they work to make their labelling lines compliant with the rules.
Manufacturers can now continue using stickers until December 31.
Pakistan Re-Advertises for Consultant to Shape Cardiac Stent Price Control Plan
Pakistan has re-advertised for a consultant to support its plan to impose a price cap on cardiac stents. The Drug Regulatory Authority of Pakistan (DRAP) first advertised for the role last month but failed to identify and hire a consultant capable of meeting its needs.
Those needs remain unchanged. DRAP is still seeking a consultant to assess the cost, sales, marketing and operating expenses and supply chain markups associated with imported cardiac stents, defibrillators, pacemakers, prosthetic heart valves and cardiac balloon catheters. The Pakistani regulator also wants the consultant to suggest a “reasonable” profit margin to build into the price cap for importers.
All that has changed is the deadline for the submission of expressions of interest. DRAP originally asked consultants to submit technical and financial proposals by 24 April. With that date having come and gone, DRAP has reset the deadline to 23 May.