In a major relief to India's leading drug maker Sun Pharmaceutical Industries, the US drug regulator Food and Drug Administration (FDA) has given a satisfactory report card for one of the key manufacturing plants that was earlier found to flout minimum quality standards.
The inspection team, which inspected the facilities between February 2-23, gave a 'voluntary action indicated' (VAI) remark to Sun's Halol plant in Gujarat. The plant had been struggling with manufacturing standards since 2014. This plant is very crucial for Sun Pharma and its future export plans to the US.
A VAI inspection classification, according to the FDA, indicates that although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time. The remark means the facility is considered to be in a minimally acceptable state of compliance with regards to current good manufacturing practice (CGMP) and if not corrected, the same or similar conditions could lead to a future inspection being classified as "official action indicated" (OAI). However, troubles are not over until the FDA closes the case and gives a clean chit to resume exports to the US, said experts.
The Halol plant was slapped with a warning letter in 2015, barring the firm from exporting products from this plant to the US. At that time, the plant was contributing close to 15 per cent of Sun's overall revenues and over 20 per cent of its US earnings. A re-inspection in 2016 at the unit was not satisfactory for the FDA to give a clean chit.
Sun's another unit at Karkhadi was also slapped with a warning letter in March 2014. A clearance in the short term for Halol will help Sun Pharma to start filing complex generics and new key products from this plant with the US FDA.
In the latest inspection, there were only three minor easily rectifiable observations, like rough, cracked and uneven surfaces that made cleaning difficult, unclean gaskets and deficiencies in the written procedures for some machines.
While a Sun Pharma spokesperson declined to comment, a US FDA inspection data given in its website indicated VAI for the unit, and the same for nine other units of manufacturers including Aurobindo's Unit IV in Medak, Suven Life Science's Pashamylaram, Teva API's JP Nagar unit etc., based on inspections done in February. Sun Pharma's share prices increased over eight per cent on the Bombay Stock Exchange (BSE) today.