Sunday, 12 October 2014, Dinesh Thakur spoke on securing the supply chain and combating the significant and evolving risks in pharmaceutical sourcing and manufacturing.  He pointed out that just over the last year and a half there have been large spikes in regulatory actions, particularly in batch failures, 483s and problems with data integrity, all of which has increased supply chain risk. He cited both China and India as problem areas, but focused on India and asked if root causes could be understood and if what was going wrong could be fixed?

“Data integrity is a big concern,” said Thakur, noting that the increase in regulatory actions in India has significantly spiked over the last three years. “Why has the problem in India gotten suddenly worse? Why has increased outsourcing led to increased risk? Is the problem from lack of training, lack of oversight? How can this be fixed?”

In looking at the pharmaceutical industry in India he noticed trends in employee attrition in pharmaceutical companies in India and found a high annual attrition rate of 15 percent.  He also investigated skill levels of both top management and lower levels; the lower level workers, he found, had little empowerment. Ultimately, he determined that “hierarchical attitudes in the pharmaceutical industry in India have played a significant role in quality problems.”

Essentially, he discovered that the significant quality problems have resulted from the culture in the industry in India and that Western concepts of quality based on openness were ineffective in a culture based on hierarchy.

“You can’t take what works in a culture of transparency and get it to work in a culture that is opaque,” said Thakur, noting that the quality problem did not exist to this degree three years ago. “The absence of a quality culture and the high cost of remediation have created the ‘perfect storm’.”

He cited one difficulty in finding solutions when he suggested that the attitude in India ‘is not conducive to recognizing that there is a problem.” And that some Indian CEOs have gone so far as to suggest that the accusations of pharmaceutical quality problems are “a vendetta from the West.”

Can regulators from the importing countries fix the problem? No, having 19 inspectors in India will not solve the problem, he said. “The regulators in the manufacturing country need to be held responsible,” he suggested in concluding his remarks.