THE MEDICAL DEVICE INDUSTRY IS SET FOR EXTENSIVE EXPANSION THROUGH 2020
The Indian Healthcare industry has seen a rapid growth in the last decade. According to a 2014 report by the Boston Consulting Group, the industry was valued at $6.3 Billion, growing at 10-12 percent per year. With the industry growth the intake of technology related to health has seen a profound increase, whether it is for treatment of chronic illness such as cancer, a new diagnostic technique for diagnosing non-communicable diseases or even checking prognosis of illness like glucometers for diabetes. It is estimated that 70 percent of this equipment is imported.
Although India’s population is over 1.3 billion, healthcare in India is primarily funded out of pocket by the individual, with the government only spending about 1 percent of the GDP on healthcare.
To date, India’s public health regulations primarily apply to pharmaceutical devices, as the regulation currently falls under the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. There is a list of a few higher risk devices including specific implants, IVD and combination devices and others that are considered “Notified” by The Ministry of Health and Family Welfare.
July 12, 2016: Draft Rules: Medical Device Rules, 2016 Version 1
October 17, 2016: Draft Rules: Medical Device Rules, 2016 Version 2
January 31, 2017: Medical Device Rule 2017