China drug capsules made from leather scraps

CHINA - According to reports, Chinese underground workshops have for years been bleaching worn-out leather scraps with lime, then processing them into a gelling agent that they then sold to manufacturers of medicine capsules.

Gelatin, the gelling agent, can be extracted from animal protein, and is widely used in foods such as gummies.

The danger is that these capsules contain a high level of chromium - a heavy metal that can severely damage a person's kidneys and liver, or even cause cancer.

The industrial gelatin was allegedly made from waste leather at plants in the country's biggest capsule-manufacturing area in East China's Zhejiang province.

Ru'ao township reportedly has more than 10 capsule-producing factories, which provide about one-third of the output on the Chinese mainland, the report said.

Veteran drug safety experts have urged the public not to panic over chromium-contaminated drug capsules illegally made from the industrial gelatin.

So far no cases of adverse reactions have been reported in the country and excessive levels of chromium detected in the capsule wouldn't necessarily lead to poisoning, said Sun Zhongshi, an expert with the National Rational Drug Use Monitoring System under the Ministry of Health.

That is also related to the low level of consumption, echoed Chen Junshi, a food safety expert at the Chinese Academy of Engineering.

"But it's definitely a crime to make capsules from industrial materials and government supervision over non-active substances like capsules should be enhanced," Chen told China Daily on Monday.

Late Sunday night, China's top drug watchdog issued an emergency notice suspending the sale and consumption of a list of capsules with reported chromium contamination.

They involves 13 kinds of drugs, including for the treatment for cold, stomach problems and infections, manufactured by nine domestic pharmaceutical companies including large, well-known ones like Xiuzheng Pharmaceutical Group in Jilin province.

Three products of Chang-chun Overseas Pharmaceutical Group and two products of Sichuan Shuzhong Pharmaceutical are also on the list.

Earlier on Sunday, CCTV revealed in an investigative program that several commonly used medicines were packed into capsules made from industrial gelatin, which contains a much higher degree of chromium than edible gelatin.

The report also found that the factory price of a similar type of capsule ranged from 40 yuan ($6.30) to 100 yuan per 10,000 capsules and the cheaper ones might have been made from industrial gelatin.

In response, the State Food and Drug Administration has instructed its local bureaus to investigate the cases and examine the drugs mentioned in the report, said an online notice issued by the administration a few hours later.

The Chinese Pharmacopoeia sets a clear standard for capsules and requires drug makers to purchase capsules from manufacturers with appropriate drug-making licenses, said the notice.

It also noted that drug makers would face legal consequences if the examination results fail to meet standards.

However, industry insiders revealed that some drug companies bought cheap capsules from underground manufacturers for cost control.

"Such companies never registered with drug authorities as required, so were out of their supervision," Sun Zhongshi said.

The problematic drugs so far have been detected in areas such as Beijing, and Jiangxi and Jilin provinces.

"I felt upset at the news," said Beijing college teacher Shao Yiwei. "And how about other drug capsules? Are they safe?"

There are more than 10,000 drugs in the country and thousands of them are packed in capsules, estimated Zhou Fucheng, deputy secretary-general of the Chinese Pharmacopoeia Commission.

According to Zhou, the manufacture of capsules is regulated and supervised as a non-active pharmaceutical product by drug authorities.

Normally, capsules are made from material from animal bones.

Also, related regulations clearly stipulate that drug companies are responsible for examining the non-active substances they use to make drugs.

However, many companies do not practice that, Sun said.

In addition, unlike active ingredients in medicines, drug authorities do not routinely test non-active substances before they hit the market, he said.

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