Indian pharmaceutical companies will soon be rated by the US on the basis of quality parameters met by them. The US Food and Drug Administration (US FDA) is working on developing quality metrics to categorise drug companies according to their adherence to norms, which will determine how they are perceived by buyers.
The number of inspections that firms have to face will also be based on how they fare in the categorisation, said Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy, USFDA.
The metrics will be applied on firms across the world, including the US.
Sklamberg is part of a high-level official delegation from the FDA that is presently touring India. The delegation has already met officials from the Ministry of Health and Family Welfare, and the Drugs Controller General of India (DCGI), besides representatives of the industry, to discuss ways to strengthen cooperation and deliberate on the broad contours of the quality metrics.
Committed to quality “We have had a very positive discussion with Indian pharmaceutical companies. They stand to gain from the arrangement as they will get to know where exactly they stand with the FDA and it will also create a cost-effective system,” Sklamberg told BusinessLine in an interaction.
If a firm has a high commitment to quality, it will show in the metrics, and firms can be inspected less often. Inspections cost money both for FDA and the companies, he explained. By building a system that uses “carrots and sticks” to encourage firms to seek higher quality, the US FDA wants to recognise firms that have achieved quality. “We want patients and purchasers of drugs to recognise such firms and say that they wanted to deal with them because they are committed to quality,” he said.
USFDA is working with its regulatory counterparts around the world.
On the increased number of inspections of Indian drug companies by US FDA, Sklamberg said it was mainly a factor of higher supplies.