Welcome to Sisyphus Highway: In Depth.

After introducing generics, originator drugs, and consistency evaluation, we now trace the development of modern pharmaceuticals and generic drugs.

From chemically synthesized drugs to mass-produced penicillin, humanity’s ability to manufacture medicine improved while the questions surrounding it grew more complicated:How do we prove a drug safe and effective? How can we protect innovation while making medicine affordable? When drugs enter a global market, how do different countries establish their rules?

The United States, India, and China gave very different answers. The United States pioneered generic substitution and built regulation through repeated problems and legal reforms. India changed its patent system, creating room for domestic generics and becoming the “pharmacy of the world.” Beginning with a relatively weak pharmaceutical base, China continually adjusted approval and quality standards.

Following these three historical paths, we examine the long technological development, institution-building, and conflict of interests behind generics.

 

- From synthetic drugs to penicillin, how did modern pharmaceuticals develop?

- United States: how did the first country to promote generic substitution gradually build its regulatory system?

· The 1938 Food, Drug, and Cosmetic Act: drug registration and approval begins

· The 1962 Kefauver-Harris Amendments: from “safe” to “safe and effective”

· The 1984 Hatch-Waxman Act: how were the boundaries of interest between innovative and generic drugs redrawn?

- India: how did the “pharmacy of the world” grow wild outside the “world order”?

· Beginning: the 1970 Patent Act amendment opens the door to generics

· Development: process-patent policy and the global AIDS epidemic fuel growth

· Expansion: after joining the WTO, India battles international drug companies over patents

- China: how did a generic-dominated market gradually establish its own standards?

· 1999: Measures for the Approval of Generic Drugs issued

· 2007: Measures for the Administration of Drug Registration revised