Between 2011 and 2016, as many as 27 drug manufacturing plants in India got FDA warning letters for data integrity violations.
Mumbai: The US Food and Drug Administration (FDA) wants Indian drug manufacturers to get their act together, citing instances of sale of drugs which lack the stated content and complaints of medicines not delivering desired results.
FDA’s India office director Matthew Thomas highlighted his concerns at an Indian Pharmaceutical Alliance (IPA) gathering here. “I had the opportunity to test some of the products with a rapid test tool. I got a blister pack of paracetamol and the test showed there was no drug in it,” he stated.
Thomas said he occasionally got samples from the US embassy’s health unit in Delhi and the complaints are usually about the medicines not giving the desired results. “I do not think any one of us wants to take such drugs which lack efficacy,” he said.
He added that further tests would be required in laboratories to ascertain whether these drugs are non-standard. “What we are telling Indian companies is that they need to take the onus of developing quality products, and investigate and follow up on complaints.”
Reacting to these observations, Cadila Healthcare chairperson Pankaj Patel said companies here do not have a different standard of quality for medicines sold in India and those exported to the US. “As a company, we follow a global standard but in order to have it uniformly implemented across the entire industry, Indian regulators will have to adopt it.”
IPA general secretary D.G. Shah said the FDA’s observation was an illustration to explain the issue of investigation of complaints, and that it was by no means a reflection of the state of Indian pharma.
Lupin’s managing director Nilesh Gupta refused to comment specifically on what Thomas had said. “There will be quality problems but how you deal with these is a more important issue. We have a global pharmacovigilance cell in Lupin and we investigate all the complaints we receive,” Gupta said.
India contributes to a third of generic medicines to the US and manufacturers here have been facing flak from foreign drug regulators, including the FDA, resulting in warning letters and delayed product approvals.
Between 2011 and 2016, as many as 27 drug manufacturing plants in India got FDA warning letters for data integrity violations. And 15 of these had import alerts issued against them, according to a Nomura Research report. None of the alerts has been withdrawn, resulting in delayed product approvals or restrictions in export to the world’s largest pharmaceutical market.
Two years earlier, six drug makers began initiating steps to improve quality standards after being caught on the wrong foot by regulators. Investment is being made in automation and staff training. Companies are also working towards making their quality control labs paperless.
“We have created teams at the plant level to identify root causes of problems and find solutions at their level,” said Umang Vohra, Cipla’s global chief executive. Cadila chairperson Patel said he’d stopped the practice of direct communication between marketing teams and the plants, reducing the unwanted pressure on employees at the plants.
By arrangement with Business Standard.