The U.S. Food and Drug Administration (FDA) hhas placed an import ban on a major Indian pharmaceutical manufacturer, Polydrug. The company is located at the Ambernath Industrial Area manufacturing plant in Mumbai.
The import bans stems from, as set out in the FDA report, concerns with intended “good manufacturing practices,” set out in FDA guidance documents, for the processing and formulating of human and animal drugs. The ban came into force on September 11, 2015.
Polydrug Laboratories manufactures anti-hypertensive, anti-fungal, anti-microbial, and muscle relaxant drugs. The company has an international supply chain and exports to several countries including Mexico, China, Korea, Russia, Taiwan, Singapore, and Ukraine.
The U.S. is not the first country to raise concerns and to place restrictions on Polydrug products. So far Canada and Europe have banned products, produced at the same site manufacturing site. Both of these bans were made earlier in 2015.
This latest FDA action comes a couple of weeks after Svizera Labs, a different Indian supplier of tuberculosis drugs to developing countries, was criticized by the World Health Organization for inadequate manufacturing standards and poor testing procedures. The WHO said approval and use of its products would be suspended if “critical and major observations are not corrected within a reasonable time frame”.
There are a number of concerns with the Indian pharmaceutical sector, as Digital Journal has reported recently. These include Marck Biosciencies’ plant in Kheda, India; three Mylan facilities; and two Ranbaxy plants.
These issues aside, India’s $15 billion pharmaceutical industry continues to supply 40 percent of the generic and over-the-counter medicines sold in the U.S.
