USA is one of the largest importers of drugs from India and the drugs exported to USA have to comply with its regulatory requirements. Isolated cases of USFDA finding shortcomings in Indian pharmaceutical products/facilities have been reported in the recent past. Details in this regard are not maintained by this Ministry.
The Central and State drug regulatory authorities take a series of steps to ensure quality, safety and efficacy of drugs. Accordingly, a number of samples of drugs are drawn for testing and inspections of manufacturing sites are carried out for ensuring adherence to Good Manufacturing, Good Laboratory, Good Storage and Good Distribution Practices. The capacity of the regulatory staff is also being enhanced through a number of programmes aimed at training and development. Workshops and training programmes are also carried out for Industry.