The Indian bulk drug or active pharmaceutical ingredient (APIs) manufacturers are facing a health security risk due to increased dependence on import of bulk drugs from China. A recent KPMG India analysis of imports data of nine strategically important intermediates suggests that by having a majority share in imports, China has achieved a near-monopoly in the Indian import basket of critical intermediates and APIs.
This has created a huge loss for bulk drug manufacturers, resulting in either becoming sick or on the verge of closure.
There are approximately 300 large companies and over 10,000 medium and small-scale companies in the sector, of which 77% manufacture formulations and 23% of units manufacture APIs.
In the wake of increasing imports from China, the bulk drug manufacturers, especially the small and mid-sized, have approached the department of pharmaceuticals under the ministry of commerce seeking revival measures due to Chinese competition. “Bulk drugs constitute nearly 25% of the pharma exports from the country. Exports from India are Rs 98,000 crore and bulk drugs and intermediates account for nearly 25%. However, there has been an increasing competition from China which has led to a stagnated growth in the bulk drug exports,” Dr PV Appaji, Pharmaceutical Export Promotion Council of India (Pharmexil), said inaugurating “2015-The Year of Active Pharmaceutical Ingredients” seminar in Hyderabad. The pharma sector has a significant presence of small and medium companies with revenues of around Rs 60,000 crore which contribute 40% of the volume and value and the rest is contributed by large companies with revenue more than Rs 90,000 crore. These API manufacturers not only export 50% of the production to various countries, but also meet majority requirement of the domestic formulations units.