Drug-maker Sun Pharma has said it is working with the Drug Controller General of India’s (DCGI) office on a concern recently raised by it involving Sun’s research facility in Mumbai.
“The company believes it has complied with all existing regulatory requirements,” Sun said, adding that an “ambiguity in guidelines” had resulted in the present situation. However, it added, “all other R&D work at Mumbai and Baroda (Vadodara), including bioanalytical work at Baroda, remains unaffected.”
Interpretative norm
An industry representative familiar with the latest salvo from DCGI to Sun said the issue is more “administrative” in nature.
Sun has a major research facility in Vadodara and a support analytical facility in Mumbai. In this case, some additional work on plasma analysis was being done at Mumbai, and the company informed the regulator’s office of the additional site and people involved.
It could be a difference in interpretation of the norm, as companies believe they have to merely notify the regulator with details of the additional work being done at a different site.
But the regulatory authority seems to want the company to have a licence for the additional work as well, the representative observed.
A lion’s share of the research work at the Mumbai facility involves bio-analytical work for finished medicines that are used in regulatory filings in India and in overseas markets. This does not get affected by the DCGI’s letter as the company has the required permissions, the representative said.
Meanwhile, the additional plasma analysis will revert back to the Vadodara facility until the Mumbai facility gets the necessary paper work in order, the representative added. The DCGI was not reachable for comments.
Across the world, for the past several years, drug companies have been coming under intense regulatory scrutiny over issues ranging from quality to marketing of medicines for unapproved usages.
Earlier this year, the India-based facilities of Ranbaxy and Wockhardt, for instance, got the wrong end of the regulatory stick, as US and UK authorities raised concerns with their manufacturing practices.
Sun Pharma shares closed marginally down at Rs 602 on the BSE on Friday.