India Planning to Revise its Drugs and Cosmetics Act

For years, companies worldwide have recognized the potential of India’s medical device market. So has the local government, though traditionally it has been slow to take advantage of that interest.

Until now.

Late last month, Indian Drug Controller General VG Somani said the country’s Health Ministry is planning to amend the 72-year-old Drugs and Cosmetics Act in order to recognize medical devices as a separate category. The move, he noted, would simplify regulation and give a fillip to the segment, valued at $2.7 billion (the fourth-largest in Asia) and expected to reach $6 billion by 2015, according to data from the United States International Trade Commission (USITC). Industry pundits expect India to surpass China in population by the middle of this century, with the number of elderly residents (those 60 and older) projected to reach nearly 200 million people by 2025. Like in other parts of the developed world, this rapid rise in elderly residents most likely will lead to an increase in spinal, bone and joint-related afflictions, which in turn, will drive the need for orthopedic devices such as joint replacements, artificial discs and bone replacement products. Over the next three years, in fact, India’s orthopedic device market is estimated to reach nearly $600 million, USITC figures indicate.

Cardiac devices and blood glucose monitoring products are expected to be in demand too, as affluence among India’s upper middle-class swells to more than 40 percent of the population over the next two decades. The USITC claims the country currently has the world’s highest number of diabetics and will have the greatest incidence of cardiovascular disease by 2020, prompting the need for such equipment as pacemakers, electrocardiograph machines, diabetes test strips and insulin pumps.

To accommodate and benefit this growth, however, the Indian government must first strengthen the device industry. Separating medical devices from drugs and cosmetics is a good first step, as it will ensure easier regulation of medical products, Somani said. Authorities also are considering creating five medical device testing laboratories, three diagnostic device testing laboratories and opening a National Drug Regulatory Training Agency. “There is an urgent need [to] strengthen infrastructure and manpower in the medical devices sector,” Somani told the Business Standard of New Delhi.

There also is an urgent need to streamline the Indian healthcare system to better accommodate medical technology, as large OEMs—namely Medtronic Inc. and St. Jude Medical Inc.—establish operations there to capitalize on the device industry’s anticipated explosive growth. To streamline the healthcare system though, experts believe the Indian government must focus on solutions in three areas: cost, geography and technology.

India’s healthcare system is costly and for the most part, based largely on patient pay. Kaustav Banerjee, St. Jude county manager for India, suggested that government officials and medical device industry representatives work together to reduce healthcare costs to increase access to devices. The government has already taken steps to reduce costs by improving reimbursement rates for low-income patients and increasing awareness of private health insurance.

Improving geographic access to medical care will boost the industry as well, enabling more people to take advantage of the latest medical technologies and, subsequently, driving demand for certain products. The government can improve access fairly easily by enhancing the healthcare infrastructure in small cities and perhaps providing better transportation to those living in remote villages with unpaved roads.

The country also must better educate its residents about the types of available solutions to various diseases, Banerjee said. St. Jude Medical is helping the government with this effort, educating Indian doctors about the symptoms and potential treatment options for cardiac afflictions such as arrhythmia, heart failure, sudden cardiac arrest, heart valve repair and replacements.