Updates on the Medical Device Regulations in India

Despite the global economic downturn, the Indian medical devices market is growing at an impressive rate. India has a relatively young population of over 1.1 billion, and its economy has fared relatively well through the global economic crisis. Prime Minister Singh projects a 6-7% growth rate in the fiscal year beginning on April 1, 2009 with a return of a 9% growth rate within the next two years.

Although few reliable statistics are available, we estimate India’s medical devices market to be about US$2.5 billion. Furthermore, about 75% of the medical devices market comes from imports. The current annual growth rate for the medical devices sector is about 6%, with projected growth rates of 12-16% through 2010. The driving forces of this remarkable growth include an increasingly affluent population that is demanding better health care, increased public and private investment in health care, and the rapid proliferation of public and private health insurance.

In order for foreign companies to enter and take full advantage of these opportunities, it is critical to understand the relatively complex regulations for medical devices in India. Currently, medical devices are regulated as drugs by the Drug Controller General of India (DCGI) of the Central Drugs Standard Control Organization (CDSCO). The lack of a drug/device distinction has created difficulties for foreign companies in the medical devices market. There is no single list (you must merge several lists together) of regulated devices with different regulations for different devices, and some devices are not regulated at all. In certain cases, product registration and manufacturing standards intended for drugs are applied to the manufacture of devices.

However, India is attempting to address these problems with a new set of guidelines for regulating medical devices and several broader reforms currently pending within the Indian government. While these regulations and reforms promise to clarify, unify, and expedite the process of manufacturing and importing medical devices into India, they also pose their own challenges and complications. Understanding the regulatory reforms imminent in India will be crucial for foreign companies looking to enter or expand their business in India’s medical markets.

New Regulations

In June 2009, the Drug Consultative Committee (DCC) and the Drug Technical Advisory Board (DTAB) approved new formal regulations for India’s medical devices sector. The Health Ministry is set to issue the notification of these new regulations soon. The final draft of the new regulations has been posted on the Central Drug Standard Organization (CDSCO) website under the title Schedule M-III. These new regulations were devised by a task force consisting of trade bodies such as the Indian Chamber of Commerce and Industry and the Confederation of Indian Industry. The task force was advised by the World Health Organization, the United States Food and Drug Administration, industry experts, and public opinion. The resulting regulations, Schedule M-III, represent India’s first systematic attempt at regulating medical devices as a separate sector from drugs.

Definition of Medical Devices

Schedule M-III creates a specific definition of medical devices as separate from drugs. Unlike a drug, a medical device is defined as a medical tool “which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means.” Medicinal products covered by the Drugs and Cosmetics Act will not fall under Schedule M-III. If there is any uncertainty whether the product falls under the Drug Category of the DCA or Medical Devices under this Schedule, regulators will look at the principal mode of action of the product.

Classification of Medical Devices

Under Schedule M-III, medical devices will be divided into four classes — A, B, C, and D — according to their risk level. Class A will include low risk devices such as thermometers and tongue depressors. Low to moderate risk devices like hypodermic needles will fall under class B. Class C will cover moderate to high risk devices like lung ventilators and bone fixation plates, and high risk devices — heart valves and implantable defibrillators, for example — will make up Class D. The regulatory procedures for medical devices will vary according to their class. In general, higher-risk devices will require more regulations and a more stringent conformity assessment process.

The Central Licensing Approval Authority (CLAA)

The CLAA, a branch of the CDSCO, will serve as the main regulatory body for medical devices. The CLAA will classify medical devices, and any manufacturer seeking a less stringent classification must send justification to the CLAA. In consultation with an expert panel on medical devices, the CLAA will also set and enforce safety standards, appoint notified bodies to oversee conformity assessment, conduct post-market surveillance, and issue warnings and recalls for adverse events.

Conformity Assessment

All medical devices will undergo conformity assessment procedures to ensure compliance with quality and safety standards before they are allowed on the Indian market. The CLAA will adopt as regulatory standards the Bureau of Indian Statistics (BIS) and International Organization for Standardization (ISO) specifications for quality management systems. To meet these standards, medical devices must be designed and manufactured in a way that achieves their intended purpose and does not compromise patient health or safety.

For Class A devices, manufactures may perform their own conformity assessment procedures. However, for class B, C, and D devices, the CLAA, in consultation with the BIS, will publish a list of notified bodies authorized to perform conformity assessment. Medical Device manufacturers must submit an application for assessment to one of these notified bodies. The necessary application materials will include technical documentation, CAPA procedures, and information about the organization and goals of the business. In the case of Class C and Class D devices, further information and clinical investigation may be required.

After receiving all of the application materials, the notified body will examine and assess whether the device conforms to BIS and ISO standards. Notified bodies will also conduct unannounced audits of manufacturing facilities to ensure that actual manufacturing practices match those described in the documentation.

Medical devices that conform to proper standards must bear the ICAC mark (Indian Conformity Assessment Certificate) which will allow them to be placed on the market and to move freely throughout India.

Import of Medical Devices

All medical devices imported into India are covered by Schedule M-III and will be subject to its guidelines. When applying for conformity assessment, manufacturers of imported devices must provide the name and address of the authorized agent or representative in India. The name and address of this authorized person or organization must also appear on the label or packaging of all imported devices marketed in India.

Imported medical devices that have already been approved by CE/USFDA, or that have been deemed equivalent to a CE/USFDA approved device, will be allowed on the Indian market without undergoing separate conformity assessment procedures.

Post Market Surveillance

Once a medical device is on the market, manufacturers must continue to submit periodic safety update reports (PSURs) to the CLAA. These reports will include patient exposure information, individual case histories, any changes to the product or safety information, and an overall safety evaluation. In addition, manufacturers will be responsible for reporting adverse events — instances related to the use of the medical device that led, or could lead, to serious injury or death. All adverse events must be reported within 10 days of their discovery, and if an adverse event has caused a serious injury or death, it must be reported within 48 hours of discovery.

Overall, these regulations should benefit foreign companies in the medical devices sector. They will expand the number of regulated medical devices, and help untangle the regulation of devices from the regulation of drugs, greatly clarifying the regulatory process.

However, many in the medical devices industry — both foreign and domestic — are pushing for even broader reforms that would create an independent authority to regulate medical devices. Several such proposals are pending within the Indian government.

The Medical Devices Regulation Bill

In 2006, the Indian Department of Science and Technology drafted and posted for public comment the Medical Devices Regulation Bill (MDRB). The bill would establish a Medical Devices Regulatory Authority (MDRA) as a government ministry headed by a chairperson with equivalent rank to a Secretary of the Government.

The MDRA would assume the functions performed by the CLAA under Schedule M-III. In addition, the MDRA would provide scientific advice and technical support to the Central Government and work with national and international organizations to harmonize international standards and practices with regard to medical devices.

This bill may not come to fruition, especially with the new Schedule M-III.

The Drug and Cosmetics Amendment Bill

However, the MDRB is not the only proposal for regulating India’s medical devices sector. The Ministry of Health (MOH) introduced a separate bill in late 2007 called the Drug and Cosmetics Amendment Bill (DCAB). This bill proposes the creation of a Central Drug Authority (CDA) to function like the United States’ FDA. The proposed CDA includes a separate medical devices department with exclusive authority to regulate medical devices.

Despite the considerable overlap of the MDRB, the DCAB, and Schedule M-III, the Department of Science and Technology and the MOH continue to promote their own proposals. This intergovernmental dispute is a cause for concern and confusion for foreign companies in India’s medical devices industry. If either, or both, of these bills were passed a period of confusion and chaos might ensue with multiple regulatory bodies claiming the authority to regulate medical devices.

The DCAB was placed before the Parliament in 2008 and is currently considered the more likely of the two proposals to pass. However, it failed to pass before the parliamentary elections of April and May 2009, and it is unclear whether the new parliament intends to pass the bill. The MDRB has yet to be placed before Parliament, but remains alive within the central government.

Looking Forward

The Indian Medical Devices market holds great opportunities for foreign companies. Schedule M-III promises to ease the process of marketing medical devices in India by creating a standardized regulatory framework. While the potential overlap between the MDRB and the DCAB might produce initial confusion, establishing a separate regulatory body to deal exclusively with medical devices would further expedite the regulatory process. These current and future medical device regulations will only improve the already impressive opportunities in India’s medical devices market.

Ames Gross is the president and founder of Pacific Bridge Medical. He is recognized nationally and internationally as a leader in Asian medical markets.

Momoko Hirose is a vice president at Pacific Bridge Medical. She works on consulting projects and research.