New Wave of Supply Shortages Expected in Germany, what do the wholesalers say? Noweda, the German full-service wholesaler draws attention to a political change in China, that is going to affect the whole pharmaceutical industry. The Chinese government adapted and tightened its counter-espionage law and the expected impact is dramatic actually.
The reason is that all pharmaceutical companies need a mandatory document called GMP (Good Manufacturing Practice) certificate from the active ingredients and drugs manufacturers, mainly based in China when the above-mentioned substances need to be imported into any country, including Germany. These certificates have a 3-year validity period and after their expiration, they need to be renewed by the German GMP inspectors, who must visit the manufacturing facilities in China. The problem is the new law is written in such an obscure and ambiguous way, that the inspectors’ visits might be endangered even by arrests and prison. The law can potentially make any information gathering by foreigners a punishable offense. This means that inspectors entering China for the audit would have to expect to be arrested by Chinese security agencies, according to Noweda.
Supply shortages Update
Two Japanese GMP inspectors have already taken the consequences of this newly adapted law and have been arrested while they have been performing their duties. This news shocked the pharmaceutical industry, but as China and India are the main and, in most cases, the only manufacturers of a massive number of active ingredients, the situation is getting pretty disturbing.
Because almost 70 percent of the generic active ingredients are produced in China, Germany (and not only) is almost completely dependent. Noweda fears massive shortages, especially of painkillers and antibiotics. That is because many Chinese pharmaceutical manufacturers no longer have valid import certificates. “We are in close contact with the supervisory authorities and our industry partners,” says Grit Brüninghold, who is responsible for strategic purchasing at Noweda. “If a solution is not found quickly, we will have to prepare for supply bottlenecks.”
“As a cooperative, we are doing everything we can to ensure that patients receive the medicines they need reliably and quickly through pharmacies,” says Dr. Michael Kuck, Noweda CEO, and sends an appeal. “Supervisory authorities and politicians must find an unbureaucratic and quick solution so that we can continue to fully fulfill our care mandate in the coming weeks and months.” The manufacturing process of medicines should be protected by any means, otherwise, it will affect significantly the whole healthcare sector and society.
Source: Antibiotics, painkillers: Noweda warns of shortages | PHARMACY ADHOC (apotheke-adhoc.de)
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