Earlier this month, the FDA approved a generic diabetes drug produced by the Indian company Sun Pharmaceutical, one of the largest producers of generic treatments in the world.
The relationship between Sun Pharma and the US Food and Drug Administration has been intense to say the least. Whilst India supplies more than 30 percent all drugs sold in the United States, Sun Pharmaceutical is one of several Indian companies that has been under the FDA’s radar over quality issues following an increase in the frequency of foreign inspections over the past two years.
Our story starts in 2014. That year, Sun Pharma voluntary recalled an estimated 2,528 bottles of its generic version of the diabetes drug Glumetza, after receiving a complaint from a customer that one of the bottles purchased contained tablets of an epilepsy drug. Later that year, the FDA announced that the company had recalled about 200 vials of gemcitabine, a chemotherapy drug, due to concerns over the process of sterilisation. Although a voluntary recall, the FDA issued a Class 2 warning stating that the use or exposure to the recalled drug may cause temporary or medically reversible adverse health consequences.
In the year 2015, the Food and Drug Administration decided to revoke an approval issued earlier in the year for Elepsia XR, a drug aimed at treating seizures, citing multiple manufacturing quality problems at its production site in Halol in the western Indian state of Gujarat. Later that year, a former Sun Pharma production facility, which in the meantime had been sold to the US firm Frontida BioPharm Inc, had been barred from selling its drugs in the United States by the FDA as it had knowingly releasing 27 lots of the hypertension drug clonidine the previous year, despite proof that the raw materials used may have been contaminated. The company did not mention at the time that the FDA had inspected the plant a year earlier between June and July of 2015, nor that it had expressed serious concerns with its quality standards. Further observations by the FDA showed that the factory staff were aware by April of 2015 that the chemical benzophenone had leached into tablets of the hypertension drug felodipine from the ink and varnish on the container label, yet these lots were not recalled until the FDA inspection by July 2015.
December of 2015, Sun Pharma said that it had received a warning letter from the US Food and Drug Administration, citing violations of good manufacturing practices at its manufacturing facility in Halol. The company acknowledged that the issues were identified during a surprise FDA inspection of the facility in September of 2014, a few months after the FDA issued an alert which prevented products mad in another Sun Pharma production site making antibiotics in Karkhadi.
Finally in 2016, the company asked the FDA to re-inspect the Halol plant in Gujarat, as this facility makes up about 15 percent of Sun Pharma’s sales in the United States.