India is the Main Non-US Producer of Prescription Drugs

This week the Office of Generic Drugs (OGD) released its annual report touting another year of record approvals of generic drugs. Almost 800 new generic drugs were approved last year by the OGD and just about half of them come from manufacturers based in India. Indian generic manufacturer had more approvals than even those located in the US. The manufacturers of finished generic drugs from India far out-numbered those from any other country. It is important to note that while GMP deficiencies at manufacturing sites in India have been in the headlines for a long time, contributions made by manufacturer located in India to supply the critically needed inexpensive generic drugs to the US market frequently goes unappreciated. This is further emphasized by the fact that for the innovator drugs, almost all the approvals were obtained by US companies. Out of 104 new drug products approved by FDA in 2016, only 4 products were from manufacturers in India. About 80% of the 104 new drug products approved were 505(b)(2).The 4 drugs approved for Indian manufactures were under the 505(b)(2) regulatory pathway. This brings out an interesting perspective; while the cheaper generic drugs are manufactured mostly by manufacturers based outside the US, the expensive new drugs are almost entirely monopolized by US companies. It shows that the US companies maintain an extreme advantage over their non-US competition with regards to innovator drugs and technologies, while not bothering much with the less profitable generic drugs. It also shows that despite the tremendous progress made by companies in India in manufacturing drugs, Indian companies are unable to compete in the developing truly new products