A good sign for Device users in India. The Indian Government is finally woken up to the fact that devices and drugs are different. As a result of this waking up and coming to terms with reality, they are planning to separate the two replacing the provisions under the Drugs and cosmetics amendment Bill tabled in 2007.
This may come as a big source of relief to Indian Device users and may cause additional cost for the domestic manufacturers who would have t now meet specific norms on device safety.
Recently I had the chance to visit the premises of Underwriters laboratories(UL) and talk to Karthik Venkataraman, a manager with UL who has been working with many Multinational Device manufacturers. UL is the market leader when it comes to Medical Device testing. Karthik did allude to the fact that domestic requirements are not very stringent and as a result Indian domestic players do not necessarily spend a lot of time testing the devices.
According to the government, the bill would provide for monitoring and setting standards for medical devices. When passed, it will help strengthen the domestic manufacturing industry and could make medical devices more accessible and affordable to the people at large in the country.
In addition the Government also plans to strengthen the its regulatory body – Central Drugs Standard Control Organisation – by providing more skilled manpower and better infrastructure in its offices across the country.
So finally Devices in India would get their own day under the sun, will it raise the standards in India, only time shall tell.