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As many Indian drugmakers find themselves on wrong side of American rules, the US health regulator FDA says they are finding contaminants like filth, pesticides and insect parts in drugs manufactured here, but similar problems exit in many other countries as well.
The US Food and Drug Administration (FDA) also warned of "appropriate action" against the companies who fail to implement "Good Manufacturing Practices".
The health watchdog said that many Indian drugmakers are well-compliant with the rules in the US, to whom India is the second largest drug exporter, while it is ready to provide guidance to others that "present problems and challenges".
The comments follow various instances of Indian pharma companies facing regulatory actions like drug recalls, warning letters and penalties from the FDA for violating the US rules.
At least two firms, Wockhardt and Fresenius Kabi, have received warning letters this month alone, while Hospira
Healthcare India and RPG Life Sciences got such letters in May. These warnings have been issued by FDA mostly for lapses in good manufacturing practices.
Besides, the FDA last week clamped down on 15 companies globally, including Gujarat-based Amrutam Life Care, for illegal sale of drugs labelled as dietary supplements and ayurvedic products for treating diabetes.
Others having faced FDA action for non-compliance with various US regulations include Ranbaxy, Dr Reddy's Labs, Sun Pharma, Cadila, Aurobindo Pharma and Glenmark.
Asked about the spate of such actions, an FDA spokesperson Christopher C Kelly told PTI in reply to emailed queries that India has been "a consistent provider of low-cost and quality medical products for many countries of the world".
"FDA seeks to ensure that Indian manufacturing facilities importing to the US understand the risks associated with their product's processes and assure they remain compliant to FDA's regulations," he said.
Listing out the problems encountered by its investigators in India, FDA said these were similar to those seen around the world and include issues associated with quality systems implementation, data integrity, and validation of various processes used in manufacturing or testing.
"FDA also encounters adulteration with contaminants that shouldn't be there, like microbiological agents (such as salmonella, listeria), or products identified with unapproved chemicals or pesticides, or presence of filth (such as foreign bodies, insect parts).
Known for making cheaper generic versions of expensive well-known drugs, India enjoys about 10% share in the finished-dose product market in the US.
According to estimates, original drugmakers across the world would lose patent over products worth over USD 100 billion in the next five years, thus opening further market for generic versions.
