Home / Companies / News /  Ranbaxy example of rogue firm that exploited gaps: whistleblower

New Delhi: Days after Ranbaxy Laboratories Ltd agreed to pay $500 million to settle civil and criminal charges of making fraudulent statements to the US Food and Drug Administration (FDA) and selling adulterated drugs in the US, Indian regulators are initiating inquiries against the country’s largest drug maker. Dinesh Thakur, a former Ranbaxy executive and the whistleblower in the case, will receive $48.7 million as his share of the settlement. In a phone interview from the US, Thakur spoke about the implications of the FDA order for the Indian generic drug industry. Edited excerpts:

Does it worry you that the FDA’s actions did not prompt the Indian regulator (Central Drugs Standard Control Organization, or CDSCO) into taking action against drugs manufactured by Ranbaxy?

There is no way for me to speak how the Indian drug regulator works. But I did read yesterday that they are beginning to look into the document (applications filed with CDSCO). It is a good start.

The FDA relies on data provided by companies. Is this a flaw that companies will continue to exploit?

The process works very well here. It is something that is done routinely. This was one example of a rogue company which clearly exploited some gaps which the FDA has now filled. It has got an international reach now, international offices and local inspectors, so clearly it is responding to the need and evolution of the global supply chain. I think the system works well, except like in this particular case, you have people who take advantage of it and you can always find ways to work around things.

Thinking back, it was a difficult time. Clearly, this was something that (was) needed to be done right, and I wish the company and management had responded by doing it the right way, the way things ought to be done. Unfortunately, they didn’t do it so I really did not have any choice but to act in the way I did. Yes, there were a lot of hardships, but I am just glad it is over and I can move on with my life now.

There is already a growing concern about the quality of drugs manufactured in India. Do you think this verdict might harm the generic drugs industry in India?

I don’t think so. This is one company that did something wrong and ultimately was held accountable for it. I think as long as the manufacturers—and it doesn’t matter whether they are Indian companies or someone else—stay true to the quality of what they are producing and don’t breach the trust of patients, there should be no problem. I cannot paint this with a broad brush.

Now that the legal battle is over, would you take drugs made at Ranbaxy’s facilities?

I travel quite frequently between the US and India, and given an option, I always carry drugs from here (the US).

What lies ahead for you?

It’s a relief and we are all glad that it is over and can get on with our lives. I have learned a lot over the past eight years. I’ve worked with the FDA and the department of justice, and with my legal team here. This is a case that crosses international boundaries. We are dealing with a company not incorporated in the United States, so there are a lot of lessons we have learnt. I’m hoping that going forward I am able to share some of what I have learnt with other drug companies and manufacturers. I have a blog that I’ve started and it’s a nascent thing.

Are there any checks and balances that you think should be incorporated into the Indian drug regulatory regime?

I’m sure that when the DCGI (Drug Controller General of India) completes their review, they will be able to look at it holistically and see where the gaps are and fill them appropriately. It’s far to early for me to comment on something like this.

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