AdvaMed, an association of medical device manufacturers, stressed that in the light of many regulatory hurdles the industry is facing in India, it is high time for the government to frame a specific set of acts and rules for the medical devices industry. The association welcomed the government’s effort to create a distinction between medical devices and drugs through a separate chapter in the Drugs & Cosmetics (Amendment) Bill, and its commitment to tackling non- communicable diseases.

AdvaMed pointed out that in the long run, a separate Act would enable the industry to effectively address India’s healthcare challenges. Sanjay Banerjee, chair of AdvaMed India said, “For decades in India, the medical device industry has gone unrecognised as a distinct pillar of the healthcare sector. Of the 14000 types of medical devices, only 14 are on the regulator’s list and even these are treated as drugs. There is a misconception here that medical devices and drugs are the same because they are both used to treat diseases. The obfuscation of the two categories in India has limited the ability of the sector to address India’s healthcare needs. There is a major gap between devices used and what is needed.”

He further said that there is a dramatic difference between the two categories. While medical devices interact with the body in multiple ways, drugs have well-defined physiological characteristics and effects. Devices are based on mechanical, electrical, materials engineering whereas drugs are based on pharmacology, chemistry and biochemistry. As far as failure is concerned, medical device failure occurs due to mechanical, electrical component failure and bio comparability problems whereas drug-related injuries or deaths are caused by overdose, incorrect drug administration or side effects.

AdvaMed informed that the D&C Bill 2013, which was introduced in Parliament last year, has recognized these differences and created a separate chapter for medical devices. “The medical device industry believes that in the short to medium term, the Bill has tremendous potential to remove the impediments that have limited the medical device industry from addressing India’s healthcare needs in a safe, effective and timely manner. This is a great first step towards more investment, innovation and manufacture.” said Abby Pratt, vice president of AdvaMed.

However, the association strongly feels that the distinction between drugs and devices for example, with respect to clinical trials is yet to be taken to the last mile. To ensure an appropriate regulatory framework, for instance, a separate cadre of regulators trained in biomedical engineering will be needed. Pricing authorities would have to be cognizant of the variations between devices and drugs in pharmaceuticals, pricing is a function of the product supplied while for medical devices, pricing is a function of the product and services provided. To reflect the true quality of care provided, there would have to be public reporting of quality information along with cost information.

AdvaMed believes that while in the short term, the Bill can go part of the way in fixing regulatory issues, in preparing for the future, a new and separate Act (as is in place in other emerging economies like South Korea and Malaysia) would pave the way towards supporting the exponential growth of the industry and its ability to tackle India’s growing non-communicable disease (NCD) burden.