India’s largest pharmaceutical has ratified that the company has received a letter from USFDA- the drug regulatory authority of the US. The letter is a warning by the US agency citing that the Indian firm has violated manufacturing standards.
USFDA’s remark is against the Halol plant, which is its largest manufacturing facility for Sun pharma. The facility supplies about 40 per cent of the products the company sells in the US.
India is the major exporter of the pharmaceutical items in the US market. Similarly, the country holds largest number of USFDA approved manufacturing facilities outside the US.
Several plants in India are inspected by the USFDA as those facilities are supplying medicines to the US. The US agency follows high standards in pharmaceutical products.
Though US is the sixth largest exporter of medicines and India the tenth largest in terms of value, large volume of generic drugs from India are sold in the US and other advanced country markets because of their low price and sound quality.
Couple of years back, Ranbaxy – the firm acquired by Sun had faced several USFDA disciplinary actions on the basis of small manufacturing related problems. Often such measures are corrected later.
Sun pharma also indicated that it will adopt the necessary corrective actions and will make a re-inspection request to the USFDA.
In recent years, the India –US pharma engagement is not known for trade but for intellectual property battles. India along with China and Pakistan are placed in the US’s priority watch list. The List contains countries that have IPR issues with the US.