The US Food and Drug Administration (FDA) has found nine deviations in Indian drug maker Cipla’s manufacturing process during a recent inspection of the company’s Bangalore plant. The Mumbai-based company, however, said the deviations are minor ones relating to manufacturing practices.
“The deviations are of a routine minor nature, suggesting need for improvements in good manufacturing practices (FDA’s drug manufacturing quality standards). One of the nine deviations is related to incorrect data entry,” a Cipla spokesman said. He said the company has taken immediate steps to correct deficiencies, and will mail a formal response to FDA within the stipulated 30 days.
The US drugs regulator refused to comment on the issue. “FDA does not comment on ongoing investigations,” said FDA spokesman Christopher Kelly in an email response.
FDA periodically inspects plants approved by it, in the US and in other markets, to ensure that drugs made at these facilities are safe to be sold in the US. For Indian plants, the FDA usually makes a biannual inspection. Industry experts said the development is not a matter of immediate concern. “The FDA has merely pointed out deviations which happen even with the case of global pharma majors. But if Cipla fails to address the issues, it could invite a warning letter, followed by harsher action,” said a Mumbai-based analyst with an investment bank, who asked not to be named.
Harsher steps from FDA could even mean freezing of new approvals from the plant. But Cipla’s US sales are small, unlike the case of other large Indian drug makers that are dependent on the US market for bulk of their revenues.
In September last year, FDA had banned 30 Ranbaxy drugs, which are manufactured at two of its plants in India. A month later, the regulator issued a warning letter to Caraco Pharmaceutical, Sun Pharma’s American subsidiary, and has also halted approval of new drug applications from its Detroit facility. In November, the agency found 15 manufacturing deficiencies at Lupin’s plant in Madhya Pradesh.
The domestic industry is divided on FDA’s actions against Indian companies in recent times. “FDA is now tightening its scrutiny of all overseas plants, as imports of generics have significantly increased over the years. India being one of the largest exporters of low-cost drugs to the US, it’s natural to have more inspections of domestic companies,” an industry official said, requesting anonymity.
However, some say FDA’s action may have been influenced by global innovator companies. “The business of global innovator companies is clearly threatened by the increasing exports of low-cost quality drugs from India,” said an industry veteran, who asked not to be named.
Last year, while defending Ranbaxy, Indian health ministry officials had said American drug companies were behind FDA decision to ban the firm’s 30 drugs.