Medical device law set to cut treatment cost

In a further boost to Prime Minister (PM) Narendra Modi’s dream “Make in India” project, a new law that will encourage manufacturing of medical devices indigenously is in the making. The Central Drugs Standard Control Organisation (CDSCO) in India, which regulates medicines and drugs, will add medical devices to its regulatory jurisdiction. With penal provisions for unauthorised manufacturers and unethical practices, the move is not only expected to boost local manufacturing of medical devices but is projected to bring down cost of treatment.

So far, the medical devices are defined as part of drugs which are regulated under the Drugs and Cosmetics Act of 1940. Through the new drafted “Medical Devices Act, 2016,” the Union health ministry proposes to give separate identity to devices — both imported and indigenously made.

The draft, which is likely to be put up for public comments soon, will have medical devices classified based on the severity of risk associated with a medical device, i.e low risk, low moderate risk, moderate high risk, high risk and will have separate rules for all categories. “The new law will help create separate and appropriate regulations for medical devices. Henceforth, there will be separate rules for both invasive and non invasive devices. The devices which are invasive will require clinical trials and all devices will be categorised in four different categories,” sources said.

The regulation will cover all instruments, apparatus, appliances, implants, material, including the software, intended by its manufacturer to be used for human beings or animals.

At present, all sophisticated machines like MRI machines, ultrasound machines etc are imported. India manufacturers only some of the small instruments. With the enforcement of new law, officials in the health ministry expect a spurt in manufacturing. “Since machines are imported, the out of pocket expenses go up. Once manufacturing starts in India, the hospitalisation cost is bound to go down. We want to encourage manufacturing in India. The common regulation will, however, remain with the Drug Controller General of India (DCGI),” sources further said.

While earlier, the ministry had proposed amendments in the existing act Drugs and Cosmetics (Amendments) Bill, 2013 regarding the same, the bill was later withdrawn keeping in view the newer areas of stem cells, regenerative medicines, medical devices etc. “To effectively regulate devices and drugs, a need to have a separate law was felt by the PM. The draft is ready now and will soon be put up for comments. We hope to introduce it in the winter session of the Parliament,” sources further stated.

The draft bill will lay down separate penal provisions for dealing with cases of “serious adverse event” means an untoward medical occurrence that lead to- a death; a serious deterioration in the health of the subject that either resulted in a life-threatening illness or injury, or resulted in a permanent impairment of a body structure or a body function, or required in-patient hospitalization or prolongation of existing hospitalization, or resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function ect.