Recent Regulatory Updates For Indias Medical Devices

Recent Regulatory Updates For India’s Medical Devices

By Ames Gross

India’s medical device market is estimated to be worth close to $3 billion this year, making it the fourth largest medical device market in Asia after Japan, China and South Korea. The country’s device market currently comprises about 5 percent of India’s $65 billion healthcare market and is expected to grow about 15 percent each year, reaching an estimated $5 billion by 2015.

About 75 percent of India’s medical devices are imported. Despite this high percentage, the country has not established comprehensive guidelines to regulate the standards and use of medical devices. Certain medical devices are classified as drugs under India’s Drugs & Cosmetics Act 1940 (DCA). These include cardiac stents, drug-eluting stents, catheters, intraocular lenses, bone cements, heart valves and scalp vein sets, among others. There still are thousands of other medical devices that are outside the purview of the DCA.

The Central Drugs Standard Control Organization (CDSCO) is the regulatory organization that implements and enforces the DCA. The CDSCO works with the Federation of Indian Chambers of Commerce and Industry (FICCI), which highlights industry issues faced by India’s device firms. The CDSCO and FICCI also work with other Indian healthcare regulators to promote the manufacturing of medical devices and to streamline regulatory processes toward global harmonization.

Recently, there has been talk of India reintroducing the Medical Device Regulation bill to Parliament. The legislation previously was introduced in 2006 to consolidate laws for medical devices and establish a regulatory body to implement and maintain the quality and safety standards of India’s medical products. However, the bill was not passed by India’s Council of States (Rajya Sabha) and it subsequently was abolished. If the proposal is reintroduced this year and passed during the July/August monsoon session in Parliament (scheduled for July 26-Aug. 27), lawmakers then would have to establish the Medical Device Regulation Act, which eventually would provide a more structured and comprehensive legal framework for medical device companies in India.

New medical regulations still are evolving in India. Over the last few months, the government implemented new regulations that may affect medical device companies, including updated technical specifications on medical equipment procured in hospitals as well as new requirements for clinical trials conducted in India.

Clinical Establishment Act 2010

Last August, India’s lawmakers enacted the Clinical Establishment Act 2010 to overcome quality issues in the country’s private healthcare sector. The Act applies to all public and privately owned medical institutions, including those involved in diagnostic laboratory work.
The law requires all entities that provide medical services to be registered with the Indian government. The legislation also established a national council and state councils for clinical establishments, with the national council responsible for compiling and publishing a national register of clinical establishments, (authorities expect this register to be ready by August 2012) and the state councils responsible for compiling and updating the state register of clinical establishments. The state councils also must set up district authorities for the registration of health units, with the district collector and district health officer as members.

The register will classify clinical establishments by category and determine the minimum standards for healthcare services. This could affect the type of medical devices demanded in India because the standards set for medical institutions might require medical devices and equipment procured to have minimum specifications and quality standards. This should provide good business opportunities for medical device companies already offering high-tech, advanced products.

Revised Technical Specifications on Medical Equipment

In March 2011, India’s Ministry of Health and Family Welfare issued a revised Compendium for Technical Specifications for the procurement of medical equipment in hospitals and other medical institutions. First launched in October 2006, the compendium was designed to improve transparency and create standardization in procuring healthcare equipment. The compendium was revised after technological advancements and available medical products for the hospital industry were taken into consideration.

The technical specifications for medical equipment in the revised 2011 compendium encompass a wide range of medical areas including neurology, cardiology, dermatology, radiology and ophthalmology, among others. The compendium serves as a useful guide for medical device companies that want to expand their businesses into India, but are unfamiliar with the latest device/equipment specifications. The revised 2011 compendium is valid until March 31, 2013.

New Regulations for Clinical Trial Registrations

Clinical research organizations (CROs) are required to register with India’s Licensing Authority to conduct clinical trials. Once permission to conduct clinical trials has been granted by the Drugs Controller General of India (DCGI), companies are required to register these clinical trials in the Indian Council of Medical Research (ICMR) clinical trial registry at www.ctri.inbefore the initiation of the trial.

In January 2011, the Ministry of Health and Family Welfare issued a notification to amend the Drugs and Cosmetics Rules, 1945, with proposals (draft rules) on clinical trial establishments. One of the proposals is a five-year validity on the registration of a CRO, unless it is suspended or cancelled earlier. CROs whose registration has been suspended or cancelled by the Licensing Authority may, within 90 days of receiving the suspension/cancellation order, appeal to the central government to reverse or modify the order.

The proposals also require CROs to implement quality assurance and quality control measures. These include well-documented standard operating procedures and complete, accurate documentation on the conduct of clinical trials and related investigations. All documentation and communication records are required to be dated, filed and preserved for five years after the completion of the study, or submission of data to CDSCO. This five-year window allows the government to perform audits and checks when needed.

While most of the above issues pertain to drug clinical studies in India, it is expected that riskier foreign medical devices also may need to supplement overseas clinical trials with local clinical trials in India to become registered.

Constant changes in India’s healthcare regulations may make business decisions difficult for foreign medical device companies. However, there still is enormous potential in India’s medical device market. With rapid economic and social development, India’s 1.2 billion people increasingly are demanding better healthcare services and facilities. Due to the public sector’s limited capabilities in providing comprehensive healthcare facilities, more than 75 percent of India’s healthcare delivery is provided by the private sector. Indian government officials estimate that 60 percent of inpatient care and 80 percent of outpatient care currently are given by private hospitals or clinics. As more private healthcare providers seek to offer high-level and more sophisticated forms of treatment, medical device companies that can supply quality products at competitive prices should stand a good chance at penetrating India’s medical device market.

Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, Md.-based consultant firm that helps 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. PBM has helped hundreds of medical companies with business development and regulatory issues in Asia.