Medical Device and Pharmaceutical Regulatory Affairs and Quality Consulting for India
As India’s population continues to rapidly increase, its economy is doing the same. The establishment of a larger middle class means more Indians are able to afford Western medicinal technology. India’s medical device and pharmaceutical markets have grown significantly over the past few years and that growth is expected to continue. Pacific Bridge Medical’s team of expert partners in India can help Western medical companies to develop or strengthen their business in India.
|India Medical Device Market Size||India Pharmaceutical Market Size|
|$3.5 billion||$20 billion|
|Projected Growth Rate: 7.5%||Projected Growth Rate: 16%|
|India Economic Indicators|
|GDP (PPP): $8 trillion|
|Per Capita GDP (PPP): $6,200|
|Real GDP Growth Rate: 7.3%|
|Population (millions): 1,270|
|Ethnic Diversity: 72% Indo-Aryan; 25% Dravidian; 3% Mongoloid and other|
The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices.
The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenterals, blood products, r-DNA derived), specific medical devices, and new drugs. In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA).
For more information, please check the CDSCO website at: http://www.cdsco.nic.in/forms/Default.aspx