India has probably the most complex set of laws, rules and regulations governing the manufacture, sate, marketing and advertising and to some extent use of drugs. Some of these have been in existence for decades. Not only this, there is also a whole host of implementing agencies and various related levels of bureaucracy. And in more recent times there has been what the government has chosen to call the drug policy, which in reality amounts to a policy directed by the industry. At frequent points during the evolution of this machinery the issue of quality control has received significant attention