Mumbai: India’s growing importance as a hub of copycat medicine producers and rising compliance problems in local factories serving the American market have prompted the US drug regulator to consider starting surprise inspections in the country.
The Food and Drug Administration (FDA) plans to follow in India the same system of facility inspections that it follows in the US and other developed countries, including an aggressive surveillance and surprise inspections of manufacturing sites, according to two people aware of the development. Both declined to be named.
“India has become a priority location for the FDA as it houses the largest number of FDA-approved drug manufacturing plants outside the US and it is also emerging as the largest exporter of generic drugs to that country,” one of the people said.
Albinus D’Sa, deputy director of FDA’s India office, did not respond to queries emailed on 3 October.
“The US regulator, since it has set up an local office in 2009, has been doing site inspections with very short notice. But with more people and infrastructure in various locations, they can (now) manage these quite frequently,” said Dilip G. Shah, secretary general of the Indian Pharmaceutical Alliance, a lobby group of Indian pharma firms.
In the past nine months, the US regulator has expanded its inspection team in India from 12 to 19, and opened two more offices, in Hyderabad and Mumbai, in addition to its first office in New Delhi.
Until now, FDA’s inspections of Indian pharma plants have always been with prior notice. The surprise checks are being considered because of instances of fabrication of documents and human error in Indian manufacturing units, the two people cited above added.
“The local industry has been trying to comply with the requirements as it can’t afford to take risks with the US market. But still, issues can happen as human errors are possible always,” Shah added.
The FDA had inducted people with expertise in crime detection and investigation in its team, said the first person cited earlier.
“The FDA has also outsourced such work to consultancy firms led by former officials from the (US) Federal Bureau of Investigation (FBI) and such investigation agencies,” added this person, who works in the Indian pharma industry.
Units of Ranbaxy Laboratories Ltd and Wockhardt Ltd were in 2009 and 2013, respectively, barred from exporting to the US. In the recent past, units of Lupin Ltd, Cadila Healthcare Ltd, Aurobindo Pharma Ltd and Strides Arcolabs Ltd have received warning letters from the FDA. Lupin said the issue was resolved in 2010.
India is home to 135 FDA-approved manufacturing units and its Rs.1.1 trillion drug industry, which largely makes generics, exported around Rs.40,000 crore of drugs in 2012, 30% of this value being exported to the US alone, according to the Pharmaceutical Export Promotion Council of India.
The FDA banned two export-oriented manufacturing plants of Ranbaxy at Poanta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh in 2009. In Ranbaxy’s case, the FDA found not only serious violations in complying with good manufacturing practices, but also data integrity issues.
The company was also at the receiving end of the US regulator’s action regarding the functioning of its third manufacturing site at Mohali in Punjab, in September. In May, Ranbaxy paid a fine of $500 million to the US department of justice after it pleaded guilty on the data integrity issue.
Mumbai-based Wockhardt also faced similar action in June regarding the functioning of its export unit at Aurangabad. These companies are currently in the process of resolving the shortcomings in manufacturing compliance.
“We have initiated the remedial measures to resolve the compliance issue at Aurangabad,” a Wockhardt executive said on Thursday. “Leading consultants have been hired to help in the corrective measures.” The official declined to be named.
“At this point, I would like to assure you that the issues that were raised by the US FDA in 2012 have been addressed and we have taken stringent steps to ensure that we meet all US FDA concerns,” Ranbaxy managing director and chief executive officer Arun Sawhney said by email. “It is important to take cognisance of the fact that since the last inspection by the US FDA at Mohali in 2012, Ranbaxy has strengthened its management, manufacturing and monitoring systems and processes to ensure quality and compliance in all areas.”
“The root cause of compliance issues in the Indian units is often linked to human elements, including the culture and the attitude of the people at the facilities and in the senior management (of the companies involved),” said Ajaz Hussain, a former head of the compliance cell at FDA, and currently a consultant to pharma companies in the US on quality issues.