Eight Chinese pharma firms may be blacklisted over quality issues

By Rupesh Dutta
New Delhi, Jan 7  The Indian government has issued showcause notices to, and may soon blacklist, eight Chinese pharmaceutical companies found to be supplying poor quality raw material to drug manufacturers in this country.

The notices were issued after a special inspection team of the Drug Controller General of India (DCGI) inspected the eight companies in China.

According to documents available with IANS, the eight companies are M/S Qilu Tianhe Pharmaceuticals, M/S Hinan Xinxiang Pharmaceuticals, M/S Zhuhai United Labratories, 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.

According to sources in the DCGI, the companies on the verge of getting blacklisted are currently supplying a huge chunk of raw material to the Indian drug manufacturers.

“The allegations against the companies are of providing poor quality products and the action against them will soon be decided by the government. This will be harsh as we don’t want the quality of drugs in India compromised,” said a senior DCGI officer.

Sources said that with government’s action against the Chine firms, India may witness a shortage of medicines, including for vital diseases such as cancer, for a couple of months.

Data from the Ministry for Chemicals and Fertilisers states that India gets 70 per cent of its raw material for drugs from China.

According to figures furnished to Parliament, Active Pharmaceutical Ingredients (APIs) worth Rs 12,254.97 crore were imported in 2016-17. The figure for 2015-16 was Rs 13,853.20 crore. (API refers to the biologically active component of a drug product.)

In 2014-15, the API import stood at Rs 12,757.96 crore and at Rs 12,061.53 crore in 2013-14.

Sources in the DCGI said that following poor quality of pharmaceutical raw products from China, the Indian government has also decided to inspect API from other countries such as the United States, Italy and some European nations.

India imported APIs worth Rs 18,372.54 crore in 2016-17. This included APIs estimated to be worth Rs 820.18 crore from the United States, worth Rs 701.85 crore from Italy, worth Rs 485.11 crore from Germany and Rs 422.01 from Singapore.

Earlier, in 2014 and 2015, the National Security Advisor’s office had warned the government of over-dependence on China for the supply of essential drugs and APIs.

In March 2017, Nirmala Sitharaman, then the Commerce and Industries Minister and now the Defence Minister, had also said that Chinese APIs were about four times cheaper than those produced in India.

Senior Congress leader Anand Sharma too expressed concern over the issue and suggested that an inter-ministerial committee look into it.


(Rupesh Dutta can be contacted at Rupesh.d@ians.in )