Asia Regulatory Roundup: Chinese Distillers Suspected of Lacing Alcohol with Viagra (4 August 2015)

Posted 04 August 2015 | By Nick Paul Taylor 

Asia Regulatory Roundup: Chinese Distillers Suspected of Lacing Alcohol with Viagra (4 August 2015)

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

Chinese Distillers Suspected of Lacing Alcohol with Viagra

Chinese law enforcement officers have found batches of white powder labeled sildenafil next to raw alcohol in two distilleries, Reuters reports. The authorities are now investigating whether the 5,357 bottles of alcohol seized during the raids contain sildenafil, the active ingredient in Pfizer’s erectile dysfunction drug Viagra.

China Food and Drug Administration (CFDA) officials in the southern city of Liuzhou suspect the Guikun Alcohol Plant and the Deshun Alcohol Plant were putting sildenafil in three baijiu products. Baijiu is a clear liquor made from grain, the alcohol content of which is typically upward of 80 proof. Distillers have created a wide range of forms of baijiu for thousands of years, but of late evidence of non-traditional versions has emerged.

One year ago, Chinese police detained a businessman for allegedly buying a kilogram of sildenafil from an online retailer and adding the active ingredient to bottles of baijiu. The scenario described this week in Liuzhou, which is around 750 miles south of where the businessman was detained, is very similar. Bottles seized in the latest raid were promoted as preserving the health of the drinker. The case combines two of China’s long-running problems: Drug counterfeiting and food safety.

Reuters

BIO Calls for Japan to Rethink Restructuring of Drug Pricing Structure

The Biotechnology Industry Organization (BIO) has called on Japan to rethink its plans to restructure the pricing and reimbursement of drugs and medical devices. A host of trade groups, including the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), have now spoken out against the plans.

Japan received the criticisms after floating plans to move to an annual schedule for reimbursement pricing, a change BIO predicts will threaten investment in innovation and delay the time it takes for patients to receive new medicines. As it stands, drugmakers in Japan are subject to biennial repricing decisions. BIO thinks the biennial model strikes the right balance, arguing it has allowed Japan to control prices over the past two decades while ensuring its citizens have timely access to new drugs.

The flipside of the argument is that Japan needs to control the cost of healthcare for its aging population, something the government thinks can be achieved by increasing the frequency with which drug and medical device prices are set. Trade groups are also concerned about plans to raise the sales tax in 2017. Japan raised its sales tax last year, at which time businesses stockpiled drugs ahead of the new rate coming into force.

Press Release

Indian Government Probes Lackluster Performance of Local Medical Device Sector

India’s Department of Pharmaceuticals (DoP) has initiated a review of the country’s medical device sector. The probe is intended to establish why domestic manufacturers have struggled to capture a share of their home market.

A lack of effective regulatory guidelines is one proposed reason for the underperformance of the local medical device industry, which DoP sees as being more effective at exporting products than selling them within India. A high-level meeting to discuss the issue is scheduled for this week. The goal is to emerge with a strategy for how infrastructure support, preferential market access and other policies can make conditions more favorable for domestic medical device manufacturers.

Industry participants have strong views on the problems. “The government must take cognizance of the fact that unfair market practices is rampant in the country due to competition from lower cost imports of China and other countries,” Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry (AIMED), told PharmaBiz. Nath cited the “low duties” on Chinese exports and prices of multinational competitors as problems the government needs to confront. 

PharmaBiz

CFDA Initiates Multi-Front Drive to Deal with Application Backlog

CFDA has outlined a multi-pronged approach to addressing its backlog of applications. The Chinese regulator proposed 10 strategies to deal with the long-standing problem, including a clampdown on fraudulent applications and a streamlining of the clinical trial review process.

Worries about the scale of China’s backlog were pushed to the fore earlier this year when it emerged that CFDA had sat on 18,000 applications. Staffing problems were widely cited as the cause of the issue but, in the absence of a major hiring spree, CFDA has devised other strategies to chip away at the backlog. The 10 policies unveiled this week follow — and in some cases complement — the recently revealed plan to make applicants awaiting approval prove their clinical trial data is legitimate.

Point two of the new strategy gives teeth to the anti-fraud drive. Organizations found to have acted dishonestly will face sanctions including being put on a public blacklist. The other nine plans outlined in the document cover the standardization of the appeal process, a clampdown on certain me-too drugs and the optimization of clinical trial approvals. CFDA is accepting comments on the guidelines until 15 August.

CFDA Notice (Chinese)

Three Years of Drug Testing in India Suggests Almost 5% of Products are Substandard or Fake

The Indian government has released data from the past three years of drug quality testing ahead of the results of its massive nationwide survey. A breakdown of the historical data shows almost 5% of the 205,448 samples tested since 2012 were found to be substandard, spurious or adulterated.

Most of the drugs that fell short of quality expectations were classed as substandard, with regulatory authorities categorizing just 271 of the tested products as spurious or adulterated, the Press Trust of India reports. As such, a little more than 0.1% of drugs tested were classed as fake. The proportion is higher than the one reported in 2009, when India last ran a nationwide drug quality survey, but far lower than some of the figures published by other sources.

Substandard drugs are, as expected, a bigger problem, with between 4% and 5% of products tested in each of the past three financial years failing to meet regulatory expectations of quality. India is on the cusp of releasing new data to give a snapshot of the situation today. Officials have gathered 50,000 samples for testing, far more than were analyzed in the last nationwide survey but fewer than formed the basis of the three-year data released this week.

Press Trust of India

Other News:

The Indian government has confirmed it is still considering setting up a dedicated regulatory unit for Ayurveda, Siddha, Unani and Homoeopathy (AYUSH) within the Central Drugs Standard Control Organisation (CDSCO). Officials have started the process of setting up the unit but are currently unable to give a timeframe for completion of the initiative. Press Trust of India

Australia’s Therapeutic Goods Administration (TGA) has alerted the industry to problems affecting clearance applications. In some cases, issues with the documentation attached to such filings are resulting in TGA being unable to view supporting evidence. The regulator is contacting affected companies to ask for documents to be sent via email. TGA Notice

Negotiators of the Trans-Pacific Partnership are reportedly nearing a compromise on some of the remaining points of disagreement, notably the exclusivity period for innovative drugs. The United States has been pushing for 12 years of exclusivity, but with Asian negotiators calling for a five-year window, the US may be willing to accept eight years as a compromise. Nikkei, More


Categories: Regulatory News

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