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Regulatory News | 30 May 2017 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India’s National Pharmaceutical Pricing Authority (NPPA) has withdrawn lists of drugmakers it thinks have violated its rules. NPPA published three such lists in recent months to get drug manufacturers including Abbott, Novartis and Sanofi to provide it with information, causing "discomfort” to the industry.
That "discomfort” prompted NPPA to take the lists off its website. NPPA said it took the action "with a hope that the companies will now be sensitized enough to comply with different provisions of [The Drug Price Control Order (DPCO), 2013].” While that implies NPPA hopes sharing the lists publicly has spurred companies into action, the price watchdog said that was not its goal. Rather, NPPA opted against sending individual letters and opted for the list approach as it lacked the resources to issue and process preliminary notices for each company separately.
The climbdown over the publication of the lists is not preventing NPPA from keeping up pressure on the companies in other areas. NPPA used the latest letter to ask companies to check the prices of drugs in their portfolios are set correctly by 30 June. The price watchdog still wants companies to give it the information on more than 1,000 cases as requested, too. This includes pricing data and explanations for their actions.
NPPA will publish a list of any companies it falsely accused, but its experience to date suggests it will maintain its position on the noncompliance of the firms after it has heard their arguments. On the basis of replies received, NPPA said, "In most of the cases [its] database is correct and violation has taken place.” The regulator warned its capabilities enable it to detect such violations and as such companies should comply with the "letter and spirit” of DPCO, 2013.
Precedent suggests NPPA will struggle to make companies comply. NPPA is still struggling to make companies enter information into its pricing database. The latest letter states this is yet to happen "in most of the cases in spite of constant reminders, meetings, notices and untiring efforts on the part of the NPPA.” The regulator wants trade associations to consider why companies are violating its requirements, adding that it has evidence of more violations it is yet to process.
Roche is recalling batches of Valium from Australia after uncovering evidence some packs contain blister sheets of other drugs. The affected Valium packs were tampered with by substituting blister sheets containing one of three other drugs manufactured by Apotex for the Roche medication.
The Therapeutic Goods Administration (TGA) of Australia said the tampering is not thought to be widespread. Even so, Roche is recalling all 5 mg tablets supplied in blister packs of 50 tablets. The recall is intended to ensure patients are not harmed, either because they do not take the Valium they need or because they inadvertently take one of the drugs swapped into their medicine packs.
TGA said the affected batches of Valium contain blister sheets of pantoprazole, a combination of codeine-paracetamol or rosuvastatin. All three products are manufactured by Apotex. In parallel to the Roche recall, Apotex is withdrawing one batch of each of the three medicines from the market. Apotex initiated the recall because some packs in the affected batch are missing blister sheets of the drugs, possibly because they were inserted into the packs of Valium.
Authorities are investigating the potential medicine tampering. News of the case comes one week after TGA revised its code of practice for tamper-evident packaging. The update sought to bring the document in line with current practices and did not impose additional requirements on the industry.
TGA published the original code of practice in 2003, three years after Herron Pharmaceuticals and SmithKline Beecham recalled products because of tampering. In those cases, criminals tried to extort money from the companies by claiming to have tampered with their products. SmithKline Beecham recalled all batches of its painkiller Panadol. Some people reportedly suffered strychnine poisoning after taking Panadol. Herron also recalled packs of paracetamol, the active ingredient in Panadol, following a poisoning and blackmail attempt.
At this stage, it is unclear why blister sheets of the three Apotex drugs were substituted for Valium. The substituted Apotex medicines either relieve pain, lower cholesterol or decrease production of stomach acid. Valium treats anxiety disorders, the symptoms of alcohol withdrawal and muscle spasms.
Valium, Pantoprazole, Paracetamol, Rosuvastatin
China Food and Drug Administration (CFDA) is planning to exempt 130 types of in-vitro diagnostic (IVD) tests from clinical trials. The regulator made the suggestion alongside the release of draft rules for the clinical development of IVDs not subject to the exemption.
In keeping with earlier initiatives to exempt medical devices from clinical trials, CFDA published the list of IVDs set to be afforded a special status alongside a description of their purpose. The draft list includes reagents used in the detection of biomarkers including C-reactive protein, hemoglobin and troponin. Physicians use these biomarkers to identify anemia, inflammation and heart attacks.
Some of the tests were previously exempted from clinical trials alongside other types of medical devices, but the vast majority are being given a special status for the first time. The historic lack of exemptions for IVDs in China has forced companies to generate data locally to bring products to market. CFDA’s proposal would lift this burden from 130 types of IVD.
CFDA has also sought to clarify the status of IVDs not covered by the list. The agency published the list alongside another document that sets out how to test and gain approval for IVDs. CFDA has used the document to explain how to pick a reference method, select a sample size and prepare an evaluation report.
Both documents are open for comment until the end of June.
CFDA Notice (Chinese)
Kazakhstan has signed an agreement to cap the prices of 105 drugs and medical devices. The list of drugs now subject to price controls includes products sold by companies including Merck KGaA, Sun Pharma and Takeda.
Politicians in the Kazakh ministry of health put together the list of products and accompanying text to protect socially vulnerable people from high prices. The plan is to cap the prices of 105 critical medicines while further curbing the cost of health care by negotiating with the manufacturers, distributors and sellers of other products.
The price caps mainly affect products made by domestic manufacturers but drugs from some better-known businesses are also subject to the ceiling. For example, officials have capped the price of Merck KGaA’s 100-tablet packs of 200 mg Yodbalans at 865 Kazakhstani tenge ($2.78). The other price caps range from KZT 40 for gauze to KZT 2,315 for the anti-inflammatory Atsekloran. A Kazakh website states Atsekloran is currently available for between KZT 2,118 and KZT 2,705.
Tags: Asia Regulatory Roundup, NPPA, Roche, Kazakhstan