Why imminent Indian government regulations on medical devices have everyone worried

The Indian medical device industry is disarray. Even industry representatives admit so. For instance, Rajiv Nath, the forum coordinator of the Association of Indian Medical Device Industry, goes so far as to state that the sector is “in a state of complete mess”.

That’s because about 99% of medical devices such as ultrasound machines, glucometers, endoscopes and ventilators are not regulated by the government. To remedy this, the Ministry of Health and Family Welfare in October made a revised draft of the Medical Device Rules public for comment. However, though there are over 5,000 kinds of medical devices in the market, the draft rules cover only about 20 devices – stents, orthopedic implants, ocular lenses, condoms, sutures and surgical dressings – that have been notified under the Drugs and Cosmetics Act, 1940.

Many doctors and health activists say that the draft rules need to do much more to ensure the safe use of all medical devices in the country. Chinu Srinivasan who runs LOCOST, a small scale non-profit pharmaceutical company in Vadodara, feels that the government should bring all medical devices under price control, just as it is currently doing for cardiac stents. “It is not clear how the price of devices that are not notified as drugs will be controlled,” said Srinivasan.

Industry bodies, meanwhile, are worried that the document, if notified without any change, will stifle domestic manufacturing and reduce the ease of doing business in India.

The vast majority of devices that are left out of the regulatory list can be imported, manufactured and sold in India without testing or certification. A trader or a manufacturer can import a low-quality device or its parts to assemble here and sell it to hospitals that may not have stringent quality checks. About 70% of the Rs 65,000 crore – that is $10 billion – medical device market in India is import dependent.

What standards apply?

Universal standards and certificates for safety and quality issued by bodies like the International Electrotechnical Commission are not mandatory and manufacturers may or may not adhere to them. “That is why India needs its own certification system or mark to put on devices,” said Jitendar Sharma, former head of the healthcare technology division at National Health Systems Resource Center of the Indian government and chief executive officer of Andhra Pradesh Medtech Zone Limited being built in Visakhapatnam. “So that consumers can trust that a device is certified and tested.”

India also does not have a dedicated facility to test medical devices. Right now the testing certificates are taken from facilities like Shri Ram Institute of Industrial Research in Delhi that tests everything from microwave ovens to LED bulbs. Dedicated medical device testing facilities are only coming up now in the new Andhra Pradesh MedTech Zone.

Recently, the Association of Indian Medical Device Industry along with Quality Council of India, created a voluntary certification system called Indian Certification for Medical Devices. “The domestic manufacturers are lining up to get the certification,” claimed Nath.

The government is also likely to introduce a mandatory certification system in the revised Drugs and Cosmetics Act that is likely to have a separate chapter on medical devices with a much bigger list of notified devices. But Pavan Choudary, director general of the Medical Technology Association of India thinks that such mandatory certification may not be a good idea since the time spent getting certification might delay the release of products in the market.

Free trade versus safety

A member of the Medical Technology Association of India said that free imports and self-regulation so far have allowed India’s medical device industry to flourish and made the country a center for medical tourism. He said that the new regulations should not be a hindrance to the free import of devices in the country. The Medical Technology Association of India only has multinational companies as its members.

“Good manufacturers take care of quality and safety,” said the association member, who did not wish to be identified.

But what about careless manufacturers and unauthorised use of medical equipment? The Atomic Energy Regulatory Board, which regulates the use of diagnostic x-ray machines, recently sealed the use of many unauthorised machines across the country.

“It is possible that manufacturers engage in such wrongdoings,” said Sharma of the Andhra Medtech Zone. “But it is something we cannot do anything about unless the national law comes.”

The national law Sharma is talking about is the Drugs and Cosmetics Act, which, he says, will apply to all medical devices.

Meanwhile, the draft Medical Device Rules are silent on refurbished devices, such as pre-owned CT scanners and MRIs, that are easy to import being about 35% less expensive than original products. Unless such devices are overhauled with genuine spare parts and manufacturer guarantees they can pose a threat to users and patients. The World Health Organisation recommends that regulators ensure that companies supplying refurbished equipment fulfill after-sale obligations including the continued availability of technical support and maintenance.

“The rules must contain provisions to regulate such devices and ensure that they are safe and efficacious to use,” said Dhvani Mehta, research fellow with the Vidhi Centre for Legal Policy in Delhi.

Mehta also says that the government should make it mandatory for manufacturers testing medical devices through clinical trials in India to sell the same device in the country once it is approved. In the draft rules, a company is only required to inform the government about the date of launch of the device.

And then, there are cases where foreign regulatory agencies like United States Food and Drug Administration approves devices to be marketed outside US, but not for sale within US market. The draft rules are not clear on how the government intends to tackle the import of such devices.

Five-year shelf life?

Another provision in the draft rules that has divided the medical manufacturer industry is the clause thats say the shelf life of a device – the period during which a device remains suitable for its intended use – should not exceed five years from the date of its manufacturing.

“It was decided keeping in mind the overall stability of a product given the India conditions which are not necessarily the same as in USA or EU,” said KL Sharma, joint secretary in the health ministry.

Nath of domestic industry association is in favour of five-year shelf life saying that Indian storage and transportation conditions are very poor and can impact stability of a product. “Shelf-life should be India specific,” said Nath.

But spokespeople for the Medical Technology Association of India dismiss the argument as baseless and non-scientific, pointing to orthopaedic implants approved in 2006 with a shelf-life of ten years that are still working well in Indian conditions. “If an international manufacturer makes a device for ten-year shelf life, he cannot make the same product with five-years shelf life only for India. That will increase his cost of production,” said one association member.

Sharma clarifies that approvals can be given on case-to-case basis if manufacturers can demonstrate longer shelf-life of a device in Indian conditions. Both domestic and multinational medical device industry feels that the government is imposing the rules of pharmaceuticals on medical devices when the two are completely different. “Drugs could be more prone to India-specific conditions because they are chemicals unlike medical devices,” says Choudary.

Conflicts of interest

The need for regulating the medical device industry in India is evident. In addition to enuring that medical devices are safe, industry practices need to be monitored. There is a rising practice of “physician-owned distributorship” by which a physician has direct or indirect financial interest in a medical device distribution agency, as analysis by international law firm Nishith Desai Associates shows. If a physician’s financial interests interfere with her or his professional judgment towards a patient, it amounts to violation of Indian Medical Council regulations. While the regulation only applies to the physician and not to the company, such practices are hardly checked and regulated.

Public health experts say that although the draft rules are a step in the right direction, the majority of the medical device industry will stay unregulated unless stringent provisions are passed in the new Drugs and Cosmetics Law.