API production in India will take a hit this week with plant closures for Aurobindo, Hetero Drugs, Divis Pharmaceuticals, and Sri Krishna Pharmaceuticals following allegations of environmental wrongdoing.
In a crackdown on drugsmakers failing to abide by the 1974 Water (Prevention & Control of Pollution) Act, the Andhra Pradesh Pollution Control Board (APPCB) will force the closure of 12 plants in the area by July 23.
As part of the swoop, bulk manufacturer Aurobindo will close it’s API (active pharmaceutical ingredient) plants Unit-IX and Unit-I, Hetero will end production at three facilities, whilst Divis and Sri Krishna will each close one factory.
Cirex Pharmaceuticals, Covalent Laboratories, Innogent Laboratories and SMS Pharma will also cease production at some of their plants.
“After detailed discussions, the board is of the firm opinion that certain industries are violating the orders of the Supreme Court of India and the ban notification issued by the Andhra Pradesh government, among others,” APPCB said in a statement.
The news follows APPCB’s stricter policies for local drug producers last year, after it reportedly suspected several plants of disposing chemicals unsafely.
Around the same time Aurobindo was issued with an FDA (US Food and Drug Administration) warning letter for two of its plants regarding cGMP (current good manufacturing practices), one specifically warning about discrepancies in the environmental monitoring data it presented from 2009 – 2010.
The firms are now reportedly now set to bring the case to India’s Appellate Tribunal on Wednesday.
During the appeal, it is said the firms will negotiate a deal which will allow them to work again, and will promise to adhere to the organisation’s rules from now on.
In a statement, SMS Pharma said they will “take the necessary steps to revoke the closure orders through the respective authorities shortly.”