Opportunity for Foreign API Companies in India

India makes a lot of their own APIs. However, in 2011, India imported $2.9 billion in Active Pharmaceutical Ingredients (APIs). In 2012, India API imports amounted to significantly more at $4.6 billion. Companies have said the steep increase in imports is to make up for local shortages. The increase in API imports is also to cut costs in preparation for new curbs on drug prices.

Much of the new API imports are coming from China. It is estimated that China’s prices for some APIs are 50-60% lower than APIs produced in India. The increase of imported APIs is raising concerns about quality. Indian law requires foreign drug manufacturing facilities that export to India to register with the Drug Controller General of India. However the law is not always successfully enforced. Not only do importers sometimes intentionally disregard the law, but Indian authorities do not have the resources to carry out the necessary overseas inspections.