Sun Pharmaceutical Industries Ltd, the country’s largest drug maker, has come under the US Food and Drug Administration (USFDA) lens. The pharma major’s manufacturing facility at Halol in Gujarat is being inspected by the US drug regulatory agency, sources told CNBC-TV18.

The inspection, which began on Monday, is expected to look into Current Good Manufacturing Practices (CGMP) followed at the facility.

CGMP inspections are normal course of business for pharma firms as the USFDA inspects facilities periodically to see whether manufacturers adhere to requisite regulatory standards. The inspections generally take place once in 18 to 24 months. While it is a routine occurrence, the development has caused anxiety among investors and analysts as Halol is Sun Pharma’s key unit that supplies products to the US market. The facility, which has a difficult regulatory history, contributes as much as 10-15 percent of the company’s total US sales, and according to analysts, its contribution has only risen since an FDA warning letter was revoked last year. The letter was issued in 2015.

In fact, the Halol facility saw at least two inspections last year. The first inspection was in February 2018 which resulted in three observations. The facility was upgraded to a Voluntary Action Indicated (VAI) status from an Official Action Indicated (OAI) status in June 2018. The VAI status meant Sun Pharma would undertake the necessary remediation and communicate it to the USFDA. Unlike in the case of OAI status, the USFDA would not need to come back and re-inspect the facility to give its approval.

Eventually, Sun Pharma received the Establishment Inspection Report for the facility in June and its first approval from the facility – for cancer injection drug Infugem -- came in July 2018.

The second inspection was in August 2018, and though the unit was issued six observations, it was later given a No Action Indicated (NAI) status from the USFDA, which is the most benign of the three statuses – OAI, VAI and NAI -- issued by the USFDA to a plant. The NAI status means they are allowed to continue manufacturing and supplying from the plant and the observations were resolvable and doesn’t require a re-inspection.

It has been a tough year on the regulatory front for many Indian pharma companies, industry sources say. It may be noted that Cadila’s Moraiya facility, which was cleared of a warning letter in 2017, was issued 14 observations in April–May this year. Similarly, Aurobindo’s Unit 3 that was inspected for over 10 days in May, was issued 10 observations. Two of Lupin’s facilities, Mandideep and Somerset, were classified as OAI by USFDA while the two plants in Goa and Pithampur Unit 2 that had warning letters since 2017 saw no upgrade from their OAI status. ​

First Published:Jun 4, 2019 2:12 PM IST