Healthcare markets in Asia: Indian medical device regulatory updates

Ames Gross

Pacific Bridge Medical

Ames Gross of Pacific Bridge provides an update on the medical device market in India as part of his ‘Healthcare markets in India’ series.

(Continued from Healthcare markets in Asia: Singaporean healthcare system overview)

Introduction

The medical device market in India was worth an estimated $3.2 billion in 2011, trailing only Japan, China and South Korea in Asia. The medical device market is currently about 6% of the overall $68 billion Indian healthcare market. It is poised to grow approximately 16% annually, reaching $5.2 billion by 2015.

India medical device regulations

Approximately 72% of medical devices in India are imported. However, there are no comprehensive regulatory guidelines for medical device usage and standards yet in India. Some medical devices are classified as drugs under India’s old Drugs &amp, Cosmetic Act (DCA) of 1940. More recently, other medical devices require registration, including drug-eluting stents, intraocular lenses, catheters, heart valves, cardiac stents and scalp vein sets. There are thousands of other medical devices which are not covered by the DCA and hence do not require registration.

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“Approximately 72% of medical devices in India are imported.”

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The main regulatory body, which enforces and implements the DCA, is the Central Drugs Standard Control Organization (CDSCO). The CDSCO works with the Federation of Indian Chambers of Commerce and Industry (FICCI), which identify issues affecting the medical device companies in India. Together, the CDSCO and FICCI also cooperate with other Indian healthcare regulators to promote medical device manufacturing and to align the India medical device regulations towards global standards.

There have been new developments in Indian medical device regulations recently. Previously, the Medical Device Regulation Bill was introduced in 2006 to create a regulatory body which would implement and maintain the safety standards and quality of medical devices in India. The bill also sought to streamline all the laws for medical devices. However, the bill did not receive the approval of the Indian Council of States, and was subsequently removed.

In 2012, the bill has been reintroduced. The Medical Device Bill will usher in a more comprehensive and structured legal framework for medical device companies operating in India if passed.

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“Indian medical device regulations are still a work in progress.”

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Indian medical device regulations are still a work in progress. In the past few months, the Indian government updated the requirements for clinical trials as well as the technical specifications for the procurements of medical equipment for hospitals.

The clinical establishment act

The Indian government approved the Clinical Establishment Act last August (2011) to improve quality standards in the private healthcare sector. Under this act, all medical institutions providing medical services must be registered with the Indian government. This includes public and private medical institutions, and those conducting diagnostic work in laboratories. The government also established a National Council and State Councils for Clinical Establishments. The National Council is responsible for creating a National Registry of Clinical Establishments. The registry is expected to be ready by August 2012. The national registry is expected to categorize all the clinical establishments and establish the minimum standard for healthcare services in India.

Updates on clinical trial registration

To conduct clinical trials, all clinical research organizations (CROs) have to be registered with the Indian Licensing Authority. After receiving permission from the Drug Controller General of India (DCGI) to conduct clinical trials, companies have to register their clinical trials with the Indian Council of Medical Research before the trial commences.

In early 2011, an amendment notice to the Drug and Cosmetic Rules 1945 containing proposals on clinical trial organizations was issued by the Ministry of Health and Family Welfare. One of the proposals calls for the CRO registration license to be valid for five years, unless their license is suspended or cancelled before the end of the five years. CROs which have their registration suspended or cancelled by the Licensing Authority can appeal to the central government to modify or reverse the decision within 90 days.

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“The evolving nature of India’s medical device regulations complicates the ease of doing business for foreign medical device companies.”

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Under another proposal, CROs are required to establish quality control and quality assurance measures. Clear and accurate documents are also required for the standard operating procedures, conduct and related investigations of Indian CROs. These documents need to be properly recorded and stored for five years after completing the clinical trials or after the data is submitted to the CDSCO. This five year window is necessary for potential government checks and audits in the future.

Even though the new proposals seem to only affect clinical studies of drugs in India, some risky foreign medical devices may also be affected. Foreign medical devices might also need to run supplementary local clinical trials in addition to their clinical trials overseas in order to be registered in India.

Updated medical equipment technical specifications

The Indian Ministry of Health and Family Welfare issued an updated “Compendium for Technical Specifications” in early 2011. The compendium will affect the procurement of medical equipment in hospitals and other medical institutions in India. The technical specifications for medical devices in the compendium cover various medical fields, including cardiology, radiology, dermatology, ophthalmology, neurology, and others.

The compendium was first launched in October 2006 to standardize healthcare equipment procurement and make the process more transparent. The 2011 update takes into account the latest technological progress and new medical device products. This compendium is a particularly useful guide for medical device companies looking to expand in India without prior local knowledge of the standards of medical devices. The compendium is valid until March 31, 2013.

Conclusion

The evolving nature of India’s medical device regulations complicates the ease of doing business for foreign medical device companies.

With rapid economic growth in India creating more wealth in the country, India’s huge population will continue to demand better healthcare services and products. With the public sector having limited capacity, the bulk of healthcare services (around 70%) in India are provided by the private sector. The Indian government estimates that the private sector already caters to 55% of inpatient care and 75% of outpatient care. Hence, as more private healthcare providers offer more sophisticated treatments, there is a good potential for medical device companies to enter the Indian medical market.

Part four of this ‘Healthcare markets in Asia’ series, looking at the medical device market in China, can be viewed here.

pharma-PPM-toolbox-5-6-March-2013

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About the author:

Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, Md.-based consulting firm that helps medical companies doing business in the Asia market. A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia. For more information, visit http://www.pacificbridgemedical.com.

How will the Indian device market evolve?