New Delhi, Dec 26, 2014: US FDA has decided to increase the staff responsible for inspection in China. They have decided to increase the number of staff from 8 to 26 and number of drug inspectors from 1 to 11.The number of US FDA inspections during 2008 to 2014 have increased and have become stricter which has led to drug shortages in the US. According to the drug master file filings in China, strict FDA inspections could lead to shortages in antibiotics, cardiovascular and chemotherapeutic drugs.
According to a statement given by a top executive from Aurobindo Pharma,” Most Indian drug manufacturers will be benefitted from any adverse impact suffered by China as they have large manufacturing capabilities and thus can fill the gap created by Chinese pharmaceutical companies in the US market fastly.” If the number of inspections increase in China then Indian manufacturers will have major opportunity for bulk drugs.
However there can be a setback also for the Indian manufacturers due to their dependence on chinese raw materials as china can restrict the usage of key raw materials intermediates for making bulk drugs for the US market. This can lead to a major impact on large number of Indian drug manufacturers until they achieve self sufficiency in the manufacturing of raw materials intermediates.
Almost $6 billion of the chinese raw materials are being imported in India and US and therefore these two countries are the largest importers of chinese pharmaceutical raw materials. Nearly 80 % of the Indian drugs are exported from India to North America. Almost 3,601 DMFs of India are registered in the US market while China has 1,216 DMFs covering only a third of it. Almost $4 billion of the bulk drugs are exported to the US market ever year by China while India exports almost $5 billion drugs to the North American market with formulations dominating the exports.Although almost 600 manufacturing facilities of China and India are approved by US FDA but Indian facilities faced increased inspections by US FDA leading to increased import alerts.IGMPI
