US FDA lens on China bad news for Indian drug makers

India imports over 80% of API ingredients from China and uses most of those for antibiotics and painkillers

The latest warning by the US Food and Drug Administration (FDA) to a Chinese active pharmaceutical ingredients (API) manufacturer has turned the spotlight on Indian drug companies’ reliance on China.

India imports over 80 per cent of API ingredients from Chinese manufacturers. Most of these are used for antibiotics and painkillers. The FDA has warned Chinese manufacturer Novacyl Wuxi Pharmaceutical over basic manufacturing problems at its facility.

“The investigator from the US Food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) and significant violations of the CGMP regulations…. These deviations and violations cause your APIs and drug products to be adulterated… the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP,” the FDA letter said. The letter was sent after an investigation conducted by the FDA in 2013.

The FDA set up an office in China after Chinese-made crude heparin was tied to dozens of deaths among dialysis patients in 2008. In 2013, the US Congress allocated funds to the FDA to expand operations in China.

India is heavily dependent on China for API ingredients but Chinese manufacturers have made headway in the US market as well. The key reason for India’s reliance is cheaper APIs from China.

There are hardly any domestic producers for many of these ingredients, making India solely dependent on imports.

Imports of APIs and advanced intermediates have grown close to 20 per cent a year from $800 million in 2004 to $3.4 billion now. China accounts for 58 per cent of such imports by value and 80 per cent by volume, trade estimates point out.

The essential drugs include Paracetamol, Ranitidine, Metformin, Amoxicillin, Ciprofloxacin, Acetyl Salicylic Acid, Ofloxacin, Cefixime, Ibuprofen, Ampicillin, and Metronidazole. A recent industry report pointed out any strain in the Sino-Indian relationship could cause a severe shortage of essential drugs.

Also, Chinese manufacturers control the pricing of such drugs. India’s dependence on China for API imports was also raised by the Opposition in the Lok Sabha in November.