India Plans To Boost Oversight By Hiring Hundreds Of Inspectors

Faced with fast growth of its domestic pharmaceutical industry and increasing quality-control problems at some of its biggest drugmakers, Indian authorities plan to add 110 inspectors – a 65 percent boost above current levels – over the next six months as part of a plan to invest $500 million, and perhaps as much as $3 billion*, in order to boost oversight, according to InPharma Technologist. Hundreds more inspectors are expected to be hired later (here is the plan). The planned initiative comes amid sweeping changes planned for licensing manufacturing facilities and a growing number of scandals. In recent weeks, the US FDA issued an import ban on products made from yet another Ranbaxy Laboratories plant and issued scathing warning letters to other drugmakers, Wockhardt and Agila Specialties, a unit of Strides Arcolab that is being purchased by Mylan Laboratories (see this, this and this). Meanwhile, India’s Ministry of Health and Family Welfare recently tested 55,000 finished dose formulation samples in state labs and found that almost 5 percent of the drugs tested were counterfeit. A test with more samples is planned. “Overall, we understand there are lapses,” Arun Panda, the ministry’s joint secretary, tells the website, “but we are really not happy with the number of samples.” In response to these developments, the Indian Central Drugs Standard Control Organization will start overseeing manufacturing licenses, a move that...Read more
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs