India regulator orders Aurobindo, others to close 12 plants

India's Aurobindo Pharma, which has had its difficulties with the FDA, is now being ordered by pollution regulators in India to close two plants.

The order comes from the Pollution Control Board in the Indian state of Andhra Pradesh. The board has demanded that 8 API- or drugmakers stop production July 23 at a dozen plants because they are violating pollution standards, reports The Economic Times. In addition to Aurobindo's two facilities, there are four operated by Hetero Labs, and one each operated by Cirex Pharmaceuticals, Covalent Laboratories, Divis Pharmaceuticals, Sri Krishna Pharmaceuticals, Inogent Laboratories and SMS Pharma, the newspaper reports. It is unclear if this is a temporary action. 

"After detailed discussions, the board is of the firm opinion that certain industries are violating the orders of Supreme Court of India, Ban Notification," the board's release says, according to NDTV.  

The board has been battling drugmakers over environmental problems and last year threatened 6 plants with closure for allegedly failing to safely dispose of the spent solvents. The board said it suspected them of selling the substances to construction companies, which were using them to produce bitumen for road construction.

While it is unclear if it is same the facilities now being targeted, the FDA in May 2011 issued a warning letter citing two Aurobindo plants in Andhra Pradesh. Inspectors said one plant was failing to meet standards to prevent bacterial contamination and was not reporting all of the problems with microbiological testing. It says some problems at the plants were repeats from earlier inspections raising "concerns regarding the robustness of your quality system." The problems were severe enough that the FDA placed the company's antibiotics plant in Andhra Pradesh under an import alert, banning any of its products from the U.S. The company also had a fire at one of the plants last year that killed two workers.

The company did not respond to a request for comment. Sources have told The Economic Times that Aurobindo believes that its plants are the best in the state and that it may appeal the decision.

- Here's The Economic Timesstory
- get more from NDTV
- read the FDA warning letter
- see the FDA import alerts

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