Going towards its ‘Make in India’ programe, the Ministry of Health and Family Welfare is planning to delink the Medical device industry from Pharmaceutical industry to foster the growth of medical device industry.
It is expected that the Ministry of Health and Family Welfare will issue the a draft notification proposing changes in the Drugs and Cosmetic Rules soon.
“We are also working towards having a separate ministry of pharmaceutical and medical devices.I have recommended this to the Prime Minister and this request is under active consideration by PMO,” said Ananth Kumar, minister of chemical and fertilizer ministry, told DNA
Rajiv Nath, cordinator of the Association of Indian Medical Devices Industry (AIMED) said, “Indian medical devices have for long been incorrectly and incompletely regulated. This has been confusing overseas and Indian investors. Medical device is an engineering industry.”
“This paradoxical situation also contributed to making India overwhelmingly import dependent and scaring away domestic and foreign investment. To rectify the situation, AIMED has been seeking changes in drug rules covering regulatory quality management framework and infrastructure requirements on the lines of the BIS and International ISO 13485 standards” Nath, informed Business Today
Currently, India fulfills its requirement by importing 70 percent of the medical devices. The total annual market size is estimated at over USD 10 billion.
The industry is hoping that the new distinction in policy will make the new roads of growth and reduce the import rate of India.
DNA further reports that along with the idea of making a separate medical device industry, the government is also planning to bear the cost of effluent treatment plant and provide some basic facilities free of cost at the upcoming medical device parks in states such as Andhra Pradesh, Haryana, Gujarat and Maharashtra, to make it globally competitive, and to lower the cost of production.
Experts said that this decision of the government to bear the cost of effluent treatment plant may bring down the cost of medical device manufacturing in India by as much as 30 per cent as the result the productivity of the medical device sector will boost.