Thermometers, BP monitors and other vital stuff that India DOES NOT regulate #MedTech #safety

Dr Ravindra GhooiThe Indian medical devices sector has lately been in the news for the government’s decision to liberate foreign direct investment controls on it. There is also some movement on the regulatory front with a decision to set up government-recognised medical device testing laboratories in the country. Apothecurry’s guest columnist Dr Ravindra Ghooi revisits the one issue that needs immediate attention but for some reason continues unaddressed. The sector’s appallingly unregulated state. Read on.

Whether it is pacemakers, bone implants or cardiac stents, patient lives hinge on the safety and effective functioning of devices. It is assumed that like other governments, India has strict laws concerning the manufacture, quality and testing of these. It may therefore come as a shock to those unfamiliar with the Indian regulatory landscape that the government seemingly does not consider many of these devices important enough to regulate.

For the record, a medical device is an instrument, apparatus, implant, or such article that is used to diagnose, prevent, or treat diseases but does not achieve its purposes through chemical action within or on the body. A toothbrush, spectacles, catheters or cardiac stents are all “devices.” It is self-evident that some devices are harmless enough, but great care must be taken while manufacturing others since they impact the health and/or life of the patient. India’s Drugs and Cosmetics Act of 1940 defines a medical device as a drug, suggesting that medical devices will be under the scrutiny of the office of the Drugs Controller General of India (DCGI).

Last year, the Office of the DCGI clarified that only 14 categories of medical devices are controlled by the government. These devices are listed in an office order dated 9th July 2014.  The order clarifies that devices other than the ones listed do not require any registration, license, permission or NOC (no-objection certificate) for their import, manufacture, sale and distribution under the Drugs and Cosmetics Act and Rules. (Italics added). The utterly confounding part is the logic behind the choice of what is regulated, and what is not. Here are some instances.
  • If one wants to import, manufacture, distribute or sell a disposable syringe, all permissions and licenses are required. But if one were to deal in drains which are inserted into the body to draw out accumulating fluids following surgery (such as mastectomy) there are no formalities to be completed.
  • Injection needles are controlled but suturing needles – used to stitch wounds or surgical incisions closed – are not. Even sutures known as cat gut, the thread-like structures used to close wounds, are not regulated. The propensity of the sutures to not break or disintegrate before intended is entirely dependent on the practices of the manufacturer.
  • Cardiac stents (used to prop open clogged arteries) are tightly-controlled, but pace makers (used to regulate heart beats) are not. Hope your heart didn’t just skip a beat.
  • As if things were not bizarre enough, stents used in parts of the body other than the heart such as intestinal stents or carotid stents can be imported from dubious sources and used in patients.The patient’s life hangs upon the honesty of the importer and the distributor. And the discernment of the treating doctor.
  • Cements and orthopedic prosthesis attract the attention of the Drugs and Cosmetics Act, and very rightly so, since these may remain in the body for a long time. You can’t have an artificial knee suddenly give way. However dental devices are not controlled at all. A dentist may import or manufacture artificial teeth or dental cements without following any rules or any standards. Clearly, in this evolved regulatory hierarchy (yet to be revealed to the larger world), knees rank higher than teeth.
  • Diagnostic devices for HIV, HBsAg (hepatitis B tests) are strictly controlled. But in a country full of diabetics and hypertensives, blood sugar monitors and blood pressure instruments have no controls. Nor do Holter monitors (devices that test heart rate and rhythm). Or thermometers.

The US drugs regulatory agency, the Food and Drug Administration has a division whose sole responsibility is to regulate normal and radiation-emitting devices. The Center for Devices and Radiological Health classifies devices based on the risk to the patient in case of their failure. The failure of a toothbrush is not likely to harm the patient, the failure of a catheter could risk patient health, but the failure of a stent could be life-threatening. Therefore, controls of toothbrushes are minimal, those on catheters are relatively greater, while those on stents are very strict

There have been various suggestions made to the Indian government on regulating medical devices better such as using a risk classification system. None have yet been adopted.

Dr Ravindra Ghooi, a pharmacologist by training, has worn many hats in the pharmaceutical industry including medical advisor to a leading drug company and vice-president of a clinical research organisation. As an educator, he has headed clinical research training institutions ICRI in New Delhi and Bilcare Research Academy in Pune. He currently runs Scientia Clinical Services, a clinical research consultancy and chairs the Ethics Committees of two major hospitals in Pune. He continues teaching as a visiting professor at various academic institutions including the Nashik-based Maharashtra University of Health Sciences. He is a published researcher and has authored three books on clinical research. The views expressed here are personal.


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