In order to address the issue about medical devices being dumped or sold at inflated prices by some countries and trading companies, Drug Controller General of India (DCGI) has assured that a robust mechanism of registration is in place to evaluate safety and quality of products based on a set of parameters of classified medical devices entering the borders of the country. A new legislation widening the scope of regulation in medical devices is in the process of being drafted, DCGI Dr GN Singh informed.
Experts say that the challenge stems from the easy availability and widespread usage of sub-standard quality medical devices in India. The origin of the device is not the issue here. Such sub-standard devices and equipment may be imported from any country or even manufactured locally within India.
These products fall short of the prescribed quality and performance standards and pose hazards to patient safety. More often than not, they are cheap imitations of established medical technology and infringe on the intellectual property legislations.
The medical devices list is long, with FICCI estimating about 14,000 product types. However, the DCGI office has regulations for only 22 devices. Yet few Indians ask doctors about the make of stents or intraocular lenses. The segment in India is worth over Rs.35,000 crore. “Imports account for Rs.27,000 crore and could balloon to Rs.85,000 crore soon," said a healthcare expert.
The US Food and Drug Administration lists 150 types of medical devices used during angioplasties and cardiac bypass surgeries and over 120 types for orthopaedic operations.
There is little awareness among Indian lawmakers that medical devices are classified into seven fields (disposables, consumable, electronics, equipment, implants, diagnostic and surgical instruments). They club these with medicines without realizing that electronic medical devices are different from, say, consumables used in operations.
China led the pack, instituting a probe last year, against western and Japanese medical device makers for selling dialysis kits at exorbitant prices in comparison to indigenous versions. Recently, Uganda and Nigeria complained about poorly-calibrated, old machines being dumped in their hospitals in the name of donation.
Domestic manufacturers, too, have repeatedly petitioned government officials about the need to indigenize this sector quickly for similar reasons.
CT and MRI scanners and ventilators can be imported with zero regulation. Patient monitors and dialysis machines are brought in without regulation. Many of these machines-some refurbished after a year's use and resold cheaper - are dumped in India, where the regulatory framework is feeble, an expert says.
A 2012 report in The Lancet showed that about 40 per cent of healthcare equipment in poor countries is out of service mainly because of ill-conceived donations-for instance, oxygen concentrators donated to a Gambian hospital worked on a voltage incompatible with the country's power supply.
Contributing about 6 per cent of India's $40 billion healthcare sector (FICCI estimate), the medical equipment sector is small but vital to the healthcare industry. Consider cardiac and orthopaedic, the sector's biggest revenue-earners. About 3 lakh Indians undergo heart procedures and around 1 lakh knee-replacement surgeries. Each involves use of medical devices. From the high end stent or a ball-and-socket knee joint to the humble clip or blood pressure-monitoring cuff, devices play a crucial role.
As per the current provisions of the Drugs and Cosmetics Act, 22 categories of medical devices are regulated as “drugs.” Medical devices are very different from drugs and pharmaceuticals. Bracketing devices as drugs poses unique challenges to the manufacturers, importers and distributors in India.