Drug-maker Lupin's recent voluntary recall of a batch of its hypertension drug Lisinopril, in the US, will not have a major financial impact on the company.

Lupin had recalled Lisinopril tablets of 30 mg in 100-count bottles, whose expiry date was October 2013, the US Food and Drug Administration said. The company-initiated recall was because of the “adulterated presence of foreign tablets”, the FDA said. Over 14,000 bottles were in circulation, it added.

“We had received a complaint of one bottle of lisinopril tablets containing one tablet of Lupin imipramine tablets. As an abundant precaution, we voluntarily recalled the batch. The recall is limited to one batch and the total value of the batch is less than $15,000,” a Lupin spokesperson clarified.

In the recent past though, several Indian drug companies have come up against quality-related concerns, including recalls. There have been drug recalls from Aurobindo and Claris — both companies involved in a sourcing tie-up with Pfizer. There have also been quality concerns raised on the manufacturing facilities of companies including Sun Pharma and Lupin. Sun is still in the process of resolving concerns over its US facilities. But last year, Lupin resolved a concern (raised in 2009) regarding one of its Indian plants.

On Lupin's latest recall, Ms Sarabjit Kaur Nangra, Vice-President (Research) with Angel Broking, told Business Line, the development would not have a material financial impact on the company's performance. However, she added, it did reflect the stringent regulatory framework in different markets, including the US, in which drug-makers operate.

In fact, recently, ratings agency Fitch singled out regulatory concerns and litigation as a key risk, as Indian drug companies targeted the US market. The outlook was good due to the continued demand for generic drugs — or chemically-similar versions of original medicines. But quality concerns could play spoil-sport, the agency had indicated, as local drug-makers seek to tap the $96-billion-worth opportunity emerging from drugs going off patent between 2011 and 2013.

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