Hyderabad: Domestic checking of imported devices must be carried out by Indian regulatory authorities since it has been found that 50% of the products are broken, repaired or recycled as they break during the process of transition. For this reason, Indian manufacturers of medical devices want the certification process of such devices to be carried out by Indian regulators only.
According to sources, in the medical industry, there are three levels of distributors and the trading which is carried out by 20 multinational companies, controls the prices of such devices in India.
It has been found that once the product is damaged as there is no checking done, it is passed on to the hospital, but the life-cycle of the machine is affected. Due to this reason, there are constant breakdowns and repairs, which have to be carried out for the machine.
Managing Director of Trivitron Healthcare, a medical device company, Dr G.S.K. Velu explained, “When a machine comes from abroad it has been made at a different temperature and has to be kept in controlled temperatures here too. If there is a defect during transition, it has been found that the life-cycle of the machine which was to last for eight to 10 years gets reduced to 5 to 6 years. The local technicians carry out minor changes but the major problem starts at the hospital level when there is a breakdown.”
“The same is the case with implants. Why are we using implants that are tested on American or European population? Why can’t we have implants which are suitable for our population?” he questioned.
The Chinese have taken the stand that they will allow only made in China products and certified by Chinese authorities only. Another clause has also been added where the clinical trials are to be carried out on Chinese patients and what is suitable for them only has to be manufactured.
But in India, it is found that the local manufacturers are also going to the US Food Drug and Administration and European authorities for certification of their products. This is because hospitals are more comfortable to take US FDA approved products.
The Indian certification of Indian Certification for Medical Devices (ICMD) is hardly known in the health sector. It has to be strengthened to gain popularity said the medical device manufacturers who are keen that the Indian manufacturing in the healthcare sector must improve.
The Medical Technology Association of India (MTaI) states that more than 75% of medical devices and more than 85% of critical care medical devices are currently imported in India. These are sold by MNC subsidiaries in the the country.
These medical devices are a very important part of healthcare, but, have been given the least importance. A medical device manufacturer on condition of anonymity explained, “The complete market is dominated by these forces and due to this reason there is too much of confusion on the pricing. The margins on devices range from 200 to 1500 per cent and that is in consumables which are required on a daily basis. It is high time; the central government directs the state governments to ensure that basics which have been in the market for the last 50 years are procured from Indian manufacturers. By doing so, the procedure prices will see a major drop.”
