News about GMP/cGMP

09.01.2018

India reports quality shortcomings of Chinese pharma companies

The Economic Times of India has published an article saying that the Indian government has issued showcause notices to eight Chinese pharmaceutical companies. Those companies were inspected by a special Indian inspection team and were found to supply poor quality APIs to drug manufacturers in India.

The eight Chinese companies who could be blacklisted by the Drug Controller General of India (DCGI) are

  • M/S Qilu Tianhe Pharmaceuticals,
  • M/S Hinan Xinxiang Pharmaceuticals,
  • M/S Guangzhao Baiyunshan Pharmaceuticals,
  • M/S Shouguang Fukang Pharmaceuticals,
  • M/S Qilu Antibiotics (Linyi) Pharmaceuticals,
  • M/S Qindao Brightmoon Seawoods and
  • M/S Shanghaoi Xiandia Hasen (Shangqiu) Pharmaceuticals.

As these companies are supplying a big part of the overall raw material imported to India, imposing restrictions against them could result in a shortage of medicines in India. 70 % of the overall raw material comes from China, mostly due to the fact that it is four times cheaper than those produced in India. The Indian government has meanwhile also decided to inspect APIs imported from other countries such as the United States, Italy and other European nations.


Source:

Economic Times of India



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