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A pall of gloom may have descended over domestic drug-makers with the US Food and Drug Administration (FDA) cracking the regulatory whip on home-grown companies Ranbaxy and Wockhardt.
Universal codes
However, mid-size drug companies with ambitions to sell their products in regulated markets such as the US should look ahead and grow their business by also investing in processes that ensure regulatory compliance, industry veteran D. S. Brar, Chairman of GVK Biosciences, told Business Line over phone. Brar had headed Ranbaxy during its dizzy growth period between the early 1990s and 2000s.
The recent directives from the US regulator are to ensure implementation of correct systems and processes when it comes to products being sold in their market, said Brar, adding that domestic drug companies need to put in place codes of conduct that are universal across the different markets they operate in. This would keep out inadvertent errors that could creep in when companies seek to meet different regulatory standards across in various markets, he explained.
Earlier this month, Ranbaxy said it would pay $500 million to settle criminal and fraud charges against it in the US. Close on its heels, the USFDA issued an import alert on one of Wockhardt’s manufacturing facilities. Away from the spotlight was another US-related product recall by local company Glenmark.
Dream team
Brar’s advice to next-generation companies aspiring to grow in regulated markets assumes significance given that he was part of the dream-team with Ranbaxy’s visionary-promoter, the late Parvinder Singh, then head of the company.
In 2004, Brar exited Ranbaxy as Chief Executive, as the company had met the milestones it had set out for itself, he had told Business Line in late 2003.
It is difficult to comment on the latest goings-on involving the USFDA and Ranbaxy, Brar said, as it was privileged information between the two.
He was, however, confident that the company’s management was “on the job” of rectifying what was amiss. Side-stepping comments on how Ranbaxy was run in the past or at present, he nevertheless gave the company his vote of confidence, saying he had “abiding trust in Ranbaxy and its products.”
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