cGMPs

FDA Scrutiny of China Will Hurt India Drugmakers

Jan 20, 2015

Increased FDA scrutiny of Chinese active pharmaceutical ingredients (API) manufacturers -- highlighted recently by the FDA's warning to Novacyl Wuxi Pharmaceutical for cGMP violations -- will also cause hardship for India drugmakers.

According to Business Standard, India imports over 80 percent of its API ingredients from Chinese manufacturers, who offer hard to obstain ingredients to India at a cheap pricepoint.

Government officials in India have urged India to create a conducive atmosphere for production of bulk drugs to cut dependence on imports. According to The Hindu, India government has decided to work out a package of interventions and concessions required to build domestic production capabilities for essential drugs and examine the cost implications.