The increasing volumes of drugs from India in the US market is proof enough that the US regulator is not specifically targeting the country on quality issues, says Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy, USFDA.

In an interview with BusinessLine, Sklamberg explains in details the reason behind the increase in inspections, the importance of coordinating on quality issues and how the proposed quality metrics will work out. Edited excerpts:

There is a perception that the inspections on Indian firms are going up. Is it true?

I don’t have a number, but I can say that in order to sell the drugs in the US, there has to be inspections. If it weren’t for the increased inspections that have occurred in the last few years, there wouldn’t have been an increase in the number of drugs sold by Indian companies. Both go together. Once firms enter the market, there are going to be surveillance inspections to make sure those drugs are of the quality that we expect.

The ratio of import alerts against Indian firms seems to be increasing, too. Does this in any way impact the drug availability in the US?

When we take an enforcement action, an import alert or any other, we do consider drug availability and other issues such as drug shortages. We have several goals. One of them is access to drugs and the other is quality of drugs and we want to make sure they are both there.

Indian Government has been asking for some time that they be given prior information when inspections are carried out by the USFDA on Indian firms. Will you oblige?

Generally speaking, we provide a schedule to the Indian Government at the end of the week (of inspections in the coming week). We do provide them notice. Drug inspections in the US are typically unannounced. It is not specific to India. It is a general approach the FDA has.

So, has the demand of prior notice stopped being an issue between India and the USFDA?

In this visit, we have had a very positive discussion about information sharing and about joint inspections and providing inspection schedules. I don’t want to characterise Indian Government’s view. But I think it was very positive.

We have carried out joint inspections with Indian inspectors. We have been giving information to the Government, and have got information in return about companies. We want to build on that.

You talked about quality metrics being developed that would rate drug companies. What was the reaction from the Indian industry? Do they have any apprehensions?

We had very positive interaction with them today. One of the advantages of developing the system is that it makes sure that everybody is on the same page. The firm will get to know where they stand with the FDA. It will improve information sharing with firms. Firms can do a better job of evaluating how they are doing. It will determine how much money is invested in quality and what their priorities are.

Will this involve a compliance cost?

We are looking to develop metrics that consist of information that firms already collect. What we hope is that it increases the efficiency of the system. If a firm has a high commitment to quality, as shown by the metrics, it can be inspected less often. And inspections cost money both for the FDA and the companies. We feel this will create financial incentive for firms seeking and achieving higher quality.

You mentioned that the USFDA workshops with Indian industry and government officials have been successful. Do you plan to continue with these?

We intend to have more workshops. That’s something we are very committed to. And that’s something we consider to have been very successful.

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