Contaminated eye drop issue tarnishing India’s image: Pharmexcil DG

On 2 February, the US Food and Drug Administration (FDA) warned against using Global Healthcare Pharma’s eye drops and Delsam Pharma’s Artificial Tears, after 55 patients suffered adverse events, including blindness, and there was one recorded death. Indian pharma industry is facing a credibility crisis, with the WHO in October saying the deaths of dozens of children in Gambia and Uzbekistan were due to contaminated cough syrups manufactured by Indian drugmakers. Edited excerpts:

How do you view the eye drops controversy?

The present eye drop issue highlighted by the US FDA and CDC is a big blow to the Indian pharmaceutical industry. It may not be a financial loss immediately, but we need to understand India’s image as “pharmacy of the world” is in question, particularly (after) the past three incidents in the last four-five months.

These three incidents are very damaging to India. Previously, there were some voluntary recalls and import alerts of the products due to technical problems, but deaths have never happened in the US. So, we can’t brush it off.

Will the US alert on Indian drugs also influence other countries?

Whenever we are talking about the credibility/capability of the Indian pharmaceutical industry to international agencies, governments and consumers, we always say our 30% of our exports are going to the US, and 52% of our exports are going to the US /EU and 55% to highly regulated markets. So, anything that happens at the level of the US FDA will create a lot of nuisances for India. The entire international media, particularly in the US, is highlighting the issue.

We have had so many challenges in the last two-three years post and during covid. We are telling the world that we are doing an excellent job, but the recent incidents, including the eye drop issue, are going to reflect badly on the image of Indian pharma despite our significant contribution to protecting the healthcare system in the world.

Why are India-made drugs being reported as of “poor quality”? Where is the loophole?

We cannot generalize the quality and efficiency on the basis of these incidents. I feel that fact-finding is not the solution. We need to reach these people.

For instance, in the eye drop case—US FDA and CDC raised an alert, and Uzbekistan, Gambian, and WHO authorities alleged that these deaths are connected to our drugs. So, the need is to open a dialogue with them. The regulators need to be proactive.