Asia Regulatory Roundup: CFDA Investigates $88M in Improperly Refrigerated Vaccines (22 March 2016)

Regulatory NewsRegulatory News | 22 March 2016 |  By 

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

CFDA Calls for Investigation Into Sellers of $88M Worth of Improperly Refrigerated Vaccines

The China Food and Drug Administration (CFDA) is pressuring local government officials to probe the sale of RMB 570 million ($88 million) worth of improperly refrigerated vaccines. Police officials think the substandard vaccine ring, which was allegedly run by a mother and daughter team, sold products to 247 people in 10 provincial regions.

Shandong, an eastern Chinese province, is the focal point of the investigation. From the province, a former doctor and her daughter reportedly bought vaccines against flu, hepatitis B, rabies and other infectious diseases from traders and resold them around the country. The primary failing of the operation, from a regulatory and quality perspective, was its lack of a cold chain, which resulted in temperature-sensitive vaccines being stored in ambient conditions. Such conditions can render a vaccine ineffective, resulting in the patient having misplaced confidence in their level of immunity.

Details of the full scope of the operation are still emerging, but a rough calculation by suggests the team sold more than two million vaccines. One of the alleged ringleaders, a doctor who was put on probation in 2009 for illegally selling vaccines, reportedly banked RMB 310 million over the past five years. The doctor-daughter team was detained in April, but officials have only just publicized the case. Details have emerged as the government has ramped up its attempts to map the vaccine network. To date, officials have arrested six suspects and detained a further 10 people.

In the near term, the case is centered on ascertaining the scope of the operation, tracking down and arresting those involved and ensuring all of the substandard vaccines are confiscated. Local officials in 20 cities have been asked to take part in the operation, specifically by helping the lead team to ascertain who has used the improperly refrigerated vaccines. In doing so, the investigation will also uncover which organizations administered the vaccines. Such organizations are supposed to request a certificate of quality when buying vaccines.

That this and other regulatory measures appear to have failed to stop the network from operating successfully will lead to questions about the effectiveness of oversight of China’s supply chain, the fragmentation of which is a longstanding source of concern,

CFDA Notice (Chinese), Reuters,Global Times, More (Chinese)

Indian Committee Backs Stronger Regulation of Pharma Packaging Waste Disposal

A committee set up by the Indian Ministry of Health has called for stronger regulation of the disposal of pharmaceutical packaging waste. The recommendation was one of several the committee made in a 31-page report on the health and environmental impact of polyethylene terephthalate (PET), the pharmaceutical packaging material that the government controversially proposed to ban in 2014.

Having discussed the topic at a meeting last year, the panel, which is made up of representatives of the Central Drugs Standard Control Organization (CDSCO) and other government bodies, ruled this week that “within a robust regulatory system and process ... the use of PET as a packaging material for pharmaceuticals can be practiced with assurance of safety.” The committee reached the position after finding a lack of conclusive, reproducible evidence that PET releases any substances at harmful levels or in any other way poses a threat to human health.

While the ruling is a boost to the Indian PET industry and everyone else who sought to overturn the plan to ban the use of the material in certain forms of pharmaceutical packaging, other aspects of the committee’s ruling suggest regulation of the sector will evolve in the coming years. For example, the committee is concerned about addition of phthalates to plastic packaging materials. With data suggesting some phthalates can be toxic, the committee is advocating case-by-case assessments of their use.

The panel is in favor of only allowing the use of diethylhexyl phthalate (DEHP), dibutyl phthalate (DBP) and diethyl phthalate (DEP) under stringent conditions. To support this new policy, the committee is advocating for a review and strengthening of existing regulatory requirements. The performance of this review is seen as a priority. In parallel, the committee is calling for regulators to restrict the use of DEHP, DBP and DEP as pharmaceutical excipients. The committee wants to restrict their use to situations in which it is unavoidable and make producers stick to daily exposure limits.

As well as advocating for these specific regulatory initiatives, the report is calling for a broader look at oversight of pharmaceutical packaging throughout the lifecycle. The committee thinks there is a need for “specific and prescriptive” guidance on the “expectations, documentation and compliance” associated with pharmaceutical packaging. Such guidelines would establish clear standards for the use of additives. The committee wants to complement this proposal with new requirements for the disposal of packaging, an area in which it thinks a lack of regulation is creating environmental risks.

Committee Report

Singapore Allows Sale of Chinese Herbs Containing Berberine as Phased Lifting of Ban Continues

The Health Sciences Agency (HSA) of Singapore will allow the sale and import of Chinese herbs that contain berberine from 1 April. In lifting the ban, HSA is continuing the phased regulatory relaxation that began in 2013 with a greenlighting of the sale of berberine in capsules and other dosage forms.

Singapore banned the use of berberine, an alkaloid found in rhizoma coptidis and other herbs used in Traditional Chinese Medicine (TCM), in the 1978 Poisons Act following reports linking the ingredient to cases of severe jaundice and brain damage in glucose-6-phosphate dehydrogenase (G6PD)-deficient babies. Worries about the risk of adverse events associated with berberine have diminished over the years, culminating in the lifting of the ban on its use in Chinese Proprietary Medicines (CPMs) in 2013.

Having registered more than 140 berberine-containing CPMs since 2013 without receiving reports of any adverse events, HSA has decided to further relax its stance. The decision, which was made after reviewing the literature and talking to advisory committees and the Ministry of Health, is a reflection of HSA’s belief that there are “no major safety concerns with Chinese herbs containing berberine when used appropriately.”

The “when used appropriately” caveat is one area of concern. HSA plans to contact practitioners of TCM to warn them against using berberine in infants, G6PD-deficient individuals and pregnant and breastfeeding women. With Chinese herbs for traditional medicine being exempt from pre-market approval and licensing, HSA is partly reliant on industry self-regulation to prevent misuse of the products. 

HSA Alert

CFDA Posts Explainer for Chemical Registration Classification Reform Program

CFDA has released an explainer to help the industry comply with its recently implemented chemical registration classification reform program. The document talks through the implications of the new policy, which came into force on 4 March.

Through the classification reform program, China has established definitions for innovative drugs and generic medicines, as well as modified products that fall somewhere between these extremes. The changes mark the end of the old classification of “new drugs,” under which a product could be classed as “new” even if it had been marketed outside China.

In parallel, the text sets out technical standards for newly registered products and the period for which they will be monitored. Another section of the explainer deals with how applicants can handle the classification system transition period.

CFDA Statement (Chinese)


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