Asia Regulatory Roundup: India Caps Prices of Drug-Eluting and Bare-Metal Stents (26 July 2016)

Regulatory NewsRegulatory News | 26 July 2016 |  By 

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

India Caps Prices of Drug-Eluting and Bare-Metal Stents

The Indian government has decided to cap the prices of drug-eluting and bare-metal stents. Officials reached the decision, which follows years of debate about the subject, after a subcommittee of cardiologists recommended that coronary stents be categorized as essential medical devices. 

Members of the subcommittee reached this position after holding four meetings to discuss whether coronary stents are essential. The meetings led to the publication of a 26-page report, in which the subcommittee outlines the rise of coronary heart disease as a public health problem in India and the role drug-eluting and bare-metal stents are playing in mitigating the effects of the trend. One of the main findings from the review is that, in the view of the subcommittee, “coronary stents should be included in the National List of Essential Medicines (NLEM), 2015.”

By making the recommendation, the subcommittee has given the Indian government expert backing for its long-gestating plan to include stents on the NLEM. Once the two classes of stents are added to the NLEM, the National Pharmaceutical Pricing Authority (NPPA) will gain the power to cap the prices of devices sold in India. NPPA is yet to state the price cap it will place on stents, but is expected to do so after debating the matter internally. As it stands, drug-eluting stents can cost up to Rs 150,000 ($2,200) in private hospitals, according to The Economic Times.

The high price of stents in certain health facilities — and markups as devices pass along the supply chain — have made the devices the focus of complaints about the cost of healthcare in India. These complaints have intensified as the use of stents has increased. Data from the National Interventional Council registry show the number of stent procedures has trebled in the past six years. The upward trend is set to continue, leading the World Economic Forum to forecast that cardiovascular disease will cost the Indian economy $2.17 trillion between 2012 and 2030. 

Committee Report, The Economic Times

CFDA Modifies Drug Quality Management Rules to Push Traceability

China Food and Drug Administration (CFDA) has changed drug quality management rules to promote good supply chain practices and ensure medicines are traceable. The revisions follow a period when a vaccine storage scandal exposed flaws in regulation of the supply chain, and criticism of CFDA’s relationship with Ali Health forced a rethink of traceability technology. 

In response to this situation, CFDA has set out new expectations for organizations involved in the production and shipping of medicines. Some of the most notable changes are deletions of sections of the earlier rules. With CFDA rethinking its approach to traceability following the Ali Health scandal, the regulator has removed references to scanning codes on medicines and uploading the data to a centralized monitoring platform.

CFDA has strengthened the wording of other sections. The new text states that organizations must be able to trace drugs back through the supply chain. CFDA wants to see companies establish computer systems to fulfill this traceability requirement. Similar stipulations were written into the drug quality rules CFDA released in 2013, but now the need to be able to trace a drug back through the supply chain, and have a computer system capable of supporting this, is emphasized more strongly.

Other sections have undergone minor revisions. CFDA has tweaked the wording of a section that sets out the cold-chain capabilities players in the vaccine supply chain must have, and made similarly slight modifications to the text explaining the experience people employed to oversee vaccine quality must possess.  

CFDA Statement, More (both Chinese)

Indonesia Commits to Monitoring Children who Received Fake Vaccines

The Indonesian Ministry of Health has committed to monitoring the progress of children who were given counterfeit vaccines. Officials made the promise as part of an attempt to ease tensions among parents in the country, which have escalated to the extent that a doctor was attacked in Jakarta.

Nila Moeloek, the Indonesian minister of health, joined with organizations representing pharmacists, pediatricians, nurses and other healthcare professionals to make the commitment. The promise to monitor children who received fake vaccines was preceded by commitments to identify all of the affected kids and re-vaccinate them for free at government health clinics. Officials claim government facilities were unaffected by the fake vaccines, which they are presenting as a private sector problem. 

The commitments to children who received fake vaccines and the attempt to differentiate between private and government-run facilities are part of an effort to reassure the public, particularly parents of affected children. As happened when China suffered a vaccine quality problem earlier this year, the situation in Indonesia has angered the public — the Associated Press reports a mob of parents attacked a doctor — and intensified skepticism about the healthcare system.

Some of that skepticism appears to be well-founded. In 2013, GlaxoSmithKline told the Indonesian National Agency of Drug and Food Control a fake version of one of its vaccines was being peddled in the country. One of the guilty parties was identified and charged. The punishment was a fine of less than $100. Subsequent reports of fake vaccines in 2014 and 2015 failed to spark a major clampdown. The decade-long vaccine scandal only became public this year following a police investigation. 

MoH Statement, More (both Indonesian), Associated Press

China Plans More Surprise Inspections After First Wave Nets Miscreants

Regulators on the Chinese island province of Hainan have committed to performing more surprise inspections after the first wave of actions led to the cancellations of drug wholesaler licenses. The inspections form part of a country-wide move to step up attempts to identify illegal activities.  

In Hainan, an initial foray into conducting surprise inspections has resulted in 12 drug wholesalers losing their licenses. The loss of the licenses stemmed from inspections in which regulators in Hainan identified serious violations of good practices and found some companies unable to provide the necessary business records. For Hainan, which has a population of approximately 8 million, the scale of the regulatory clampdown is significant.

Officials in Hainan now plan to increase the number of surprise inspections they conduct as part of a campaign to crack down on illegal activity in the pharmaceutical industry. The focus of the initiative and the use of surprise inspections to enable it are in keeping with the prevailing areas of regulatory focus across China, which, driven by the orders of senior government officials and the fallout from the vaccine storage scandal, is trying to improve drug quality and practices. 

CFDA Notice (Chinese)

Other News:

The Therapeutic Goods Administration (TGA) of Australia has approved AbbVie’s Humira for use in the treatment of active moderate to severe hidradenitis suppurativa. TGA’s decision follows months after the United States Food and Drug Administration and the European Medicines Agency cleared Humira for use in the indication. TGA Report

CFDA has released draft regulations on drug export and registration for consultation. The registration text, which forms part of China’s attempts to reform the drug and medical device approval process, is open for comment until 26 August. CFDA is accepting comments on the drug export regulations until August 30. Registration Regulations, Export Regulations (both Chinese)



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