USFDA Enforcements To Push Up Costs For Indian Pharma

 HYDERABAD: Stricter norms by American drugs regulator USFDA will lead to higher compliance costs for Indian pharma, although these enforcements are not country specific but more on account of "cultural differences", said a report by global credit rating agency Crisil.

The companies have little choice but to invest in bringing compliance processes up to speed, it said, adding that the cost of not doing so (warning letters/import alerts may impact both current revenues and future pipeline) will be far higher.

In general, the cost of compliance of drug makers has doubled over the past 5 years. About 30 percent - or $ 4 billion worth - of India's pharma exports are to the U.S.

India remains a location of significant importance to the FDA as it has the largest number of FDA-approved drug- manufacturing plants with over 150 formulation facilities and is also the second-largest pharmaceutical supplier to the U.S. market in terms of volume of generic drugs.

The enforcements by U.S. Food and Drug Administration over Indian pharma companies, though not country specific, are mainly on account of issues such as cultural differences and attitude of employees, it said.

READ MORE: Conglomeration for Consumer Goods Companies

Budget 2014: A Balm for Businesses Hurt By Tax!