MEDICAL & VETERINARY DIAGNOSTIC KITS IN INDIA :A Brief Overview of Regulatory framework for Medical & Veterinary Devices in India
The Indian healthcare sector has become one of India’s largest sectors, both in terms of revenue and employment. It has experienced rapid change in recent years and has become significantly more visible over the last decade, with a renewed focus from the government and growing market demand for healthcare services and products. The Indian population is growing at a rate of 1.6 percent per year and has an elderly population of over 100 million. Rapid economic growth, rising middle class incomes, and increased market penetration of health insurance providers are fueling growth in the industry. In addition, changing demographics and a shift from chronic to lifestyle diseases has led to a boom in healthcare spending across the country.
India has emerged as one of the leading markets for pharmaceutical products. Increase in the private healthcare infrastructure, widening rural markets, and inclusion of newer technologies have placed healthcare as an independent sector in India. With privatization of healthcare, the medical devices sector is growing too.
In order to regulate the import, manufacture, distribution and sale of drugs and cosmetics, the Drugs and Cosmetics Act, 1940 (“D&C, Act”) was introduced in India in 1940. However, no separate legislation/regulation has been enacted for regulating the import, manufacture, distribution or sale of medical devices in India till date by the Government of India.
The Central Drugs Standard Control Organization (CDSCO) is the key medical regulatory organization in India. Since 2006, both the Indian Department of Science and Technology and the Ministry of Health and Family Welfare have sought to completely restructure the regulations for the medical devices. Till date, neither of these attempts has been successful. Medical device market is quite diverse which includes medical and diagnostic equipment; medical implants like heart valve and cardiac stents, pacemakers, cannulae, knee joints; and lower end plastic disposables, blood bags, IV sets, syringes etc. In light of its widespread applicability, overall medical device market is experiencing reasonable growth.
Historically, most Indians had very limited access to any type of modern medical service. Today, however, the situation is much improved. There is a growing awareness about health issues within India, an increasing demand for quality care at affordable prices, further the Indian Healthcare industry is in a steady growth trajectory and is expected to grow in the next few years.
The Indian economy is worth about US$1,243 billion and rapidly getting bigger . The GDP growth reached 9% in the year to March 2008. The 2010-11 budget extended the coverage to another 20% of the Indian population covered by the National Rural employment Guarantee Act (NREGA) programmes, who have worked for more than 15 days during the preceding financial year[3].Budget 2010-11 also allocated US$ 2,920 million under the National Rural Health Mission (NRHM), an increase of 15% over the previous year.
In India, import, manufacturing, sale and distribution of drugs and medical devices is regulated under the Drugs & Cosmetics Act, 1940 (the Act), Drug & Cosmetic Rules, 1945 and Medical Devices Rules, 2017. The registration of both drugs and medical devices are processed by the Central Drug Standards Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare. CDSCO serves parallel function to the European Medicines Agency of the European Union, the MFDS or KFDA of Korea, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.
Regulatory Requirement for importing medical devices in India
For importing drugs and medical devices in India, obtaining registration certificate and import license from CDSCO is a mandatory requirement. At present, only those medical device categories which are listed as ‘notified device’ by the CDSCO can be registered for its import, manufacturing, sale and distribution in India. Several medical devices are still classified as a ‘drug’ under the Act, and require regulatory approval.
To import medical devices in India, the applicant is required to submit an application in the prescribed form, to the CDSCO’s licensing authority for obtaining registration certificate and import license. The licensing authority usually issues the registration certificate within 9 months from the date of receipt of the application, submission of accurate documentation and the registration fees. The registration certificate shall be valid for 3 years and may be renewed thereafter.
Regulations on Medical Devices in India
Undoubtedly, the medical devices and surgical instruments are currently not covered under the regulatory framework in India. However, any device which is intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified by the Central Government by notification in the Official Gazette would be considered as a drug under the D&C Act and provisions of D&C Act and Rules made therein would be applicable on such device. From time to time, Ministry of Health and Family Welfare, Government of India vide gazette notifications has notified certain medical devices as drugs under the D&C Act.
Prior to 2005, only medical devices such as disposable hypodermic syringes, tubal rings, condoms, metered dose inhalers, were required to be registered in India. In 2005, the Ministry of Health and Family Welfare (MOHFW) vide gazette notification dated 6 October 2005[5] further notified 10 sterile devices (“Notified Medical Devices”) to be considered as drugs and consequently regulated their import, sale and manufacture under Section 3(b) (iv) (defined below) of the D&C Act.
Regulating Authority for Notified Medical devices
In India, the Central Drugs Standard Control Organization (‘CDSCO’) is the main regulatory body currently regulating import, sale and manufacture of medical devices which have been notified as drugs by virtue of Section 3(b) (iv) of the D&C Act.The CDSCO lays down standards of drugs, cosmetics, diagnostics and devices and issues licenses to drug manufacturers and importers. It also lays down regulatory measures, amendments to Acts and Rules and regulates market authorization of new drugs, clinical research in India and standards of imported drugs etc. The CDSCO has setup a separate division which is called Medical Device Division in order to facilitate mattes related to Notified Medical Devices. The hierarchy of medical device division of the CDSCO in India is as follows:
Regulatory Overview of the Notified Medical Devices
The main regulatio ing Notified Medical Devices in India has been the Drugs and Cosmetics Act, 1940(‘Act’) and the Drugs and Cosmetics Rules, 1945 (‘Rules’). Notified Medical Devices are currently covered under the definition of Drugs under the Act Section 3 (b) (iv) which reads as follow:
“b) “drug” includes—
(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board ;]”
The provisions of the Rules also deal with Notified Medical Devices and as they are currently defined as drugs and import and/or manufacture of them requires licenses to be obtained from the appropriate licensing authority as laid down under the Rules.
Rule 22 of the D&C Rules states that the licensing authority may with the approval of the Central Government by an order in writing delegate the power to sign licenses and Registration Certificate and such other powers as may be specified in the order to any other person under his control.’
Rule 109A deals with labelling of medical devices and states that: “ The labelling of Medical Devices shall conform to the Indian Standards Specifications laid down from time to time by the BIS[6]in addition to any other requirement prescribed under the said rules.”
Rule 125A states that the standard for medical devices is stated in Schedule R1 namely, Sterile Disposable Perfusion sets for single use only (Sections 2 and 3 of item 1 of IS 9824:1981 read with the Amendment number 1); Sterile Disposable Hypodermic syringes for single use only (IS 10258:1982) and Sterile Disposable Hypodermic needles for single use only (IS 10654:1991) must conform to the Indian Standards specification laid down by the Bureau of Indian Standards (‘BIS’).
According to the BIS, the BIS product certification scheme is essentially voluntary in nature, and is largely based on ISO Guide 28, which provides general rules for third party certification system of determining conformity with product standards.
Currently medical devices and surgical instruments are not covered under mandatory certification.
The Medical Equipment and Hospital Planning Division Council (MHDC) of BIS deals with Medical Devices
The Programme of Work prepared & updated Sectional Committee wise as on 1 March 2012 deals with “Standardization in the field of Surgical Instruments, Medical Equipment, Surgical Dressings, Artificial Limbs, Rehabilitation Equipment, Diagnostic Kits, Veterinary Surgery Instruments, Dental Equipment, Laboratory Instruments & Equipment, Hospital Planning and Healthcare Services”. It is stated that this publication will provide the community of Standards users a convenient tool for obtaining the latest information about all the published new and up coming Standards in the field of Medical Equipment & Hospital Planning. List of Indian Standards under BIS Certification Scheme along with list of licensees, ISS wise, is also given in this programme of work.
Significant notifications/guidelines of CDSCO with respect to Notified Medical Devices
CDSCO vide gazette notifications issued on 5 September, 2007 has notified [7] that Free Sale Certificate in country of origin issued by the Ministry of Health/National Regulatory Authority is a pre-requisite for the registration. Any change in the Design and/or change in material and/or change in composition of an already approved/ registered medical device will require prior approval of Drugs Controller General of India (“DCGI”).
Based on large number of requests seeking clarity on issues relating to registration, manufacture and import of Notified Medical Devices, from both manufacturers of Medical Devices and their representatives from India and abroad, CDSCO has time and again come up with clarifications & explanations on the guidelines. It has stated vide Notification dated June 2008[8] that for the purpose of registration of medical devices and in order to calculate the fees required to be deposited with the application, a group or family of devices manufactured by or for the same manufacturer and which has the same basic design, performance characteristic relating to device safety, effectiveness of the device and its intended use (which includes variation in sizes and shapes) would be considered one single device. It was also clarified that a device may also include package of various devices or sub systems that are required to be used together as a single functioning device.
On 20 March 2009, the Central Drugs Standard Control Organization (CDSCO) clarified that sterile medical devices such as spinal needles, insulin syringes, endotracheal tubes, cardiac patches, and extension tubes were also required to be registered.
On 4 August 2010 CDSCO released new guidelines for document submission for medical device product registration . Under CDSCO’s current system, medical devices requiring registration need approval from the DCGI. After receipt of the application with fees, evaluation begins. DCGI may require clinical testing in India or request information on clinical trials performed abroad.
In light of developing clearer provisions with regard to regulation of Medical Devices, the Government upon the recommendation of the DCGI and examination by the Expert Committee, has further confirmed 11 devices such as Spinal needle, Insulin syringes, three way stop cock as an accessory of I.V. Cannula/Catheter/Perfusion Set, Introducer sheath, Cochlear implant, Close wound drainage set, AV fistula needle, Extension line as an accessory of Infusion set, ANGO kit/PTCA/ Cath Lab kit, Measure volume set and Flow regulator as an accessory of Infusion set as drugs vide notification dated 5 March, 2012.
New Proposed Medical Devices Regulation Bill
In 2006, the Medical Devices Regulation Bill (MDRB) was proposed by the Ministry of Science and Technology. The MDRB was designed to consolidate laws related to medical devices and establish the Medical Device Regulatory Authority of India (MDRA). This proposal was aimed at establishing and maintaining a national system of controls for the quality, safety and availability of medical devices in India. If enacted, the MDRB will govern all medical devices throughout India. Companies wishing to import devices into India or manufacture products locally will have to comply with the design, manufacturing, packaging, labeling, import, sale, use, and disposal requirements of the MDRB. Also the bill will expand the list of products requiring registration.
The Bill provides for the creation of a Medical Device Regulatory Authority which has been empowered with extensive powers relating to fining and imprisoning defaulters. Besides looking to harmonize the standards in accordance with the global norms to push the export potentials, the Bill also seeks to lay down concrete norms on import of devices and their conformity with the Indian standards. Standards notified by the Bureau of Indian Standards or other international standards making bodies like International Organization for Standardization (ISO), may be incorporated for harmonization. The Bill seeks to regulate the design, manufacture, packaging, labelling, import, sale, usage and disposal of medical devices in India.
With a view to raise the level of control on Medical Devices, the Drug Technical Advisory Board (DTAB) in India has submitted the final draft of the guidelines on medical devices and has recommended strict implementation of Indian Conformity Assessment Certificate (ICAC) for the medical devices manufactured, imported and marketed on Indian market under Schedule M III of Drugs & Cosmetics Rules 1945. The Medical Devices have been classified into Class A, B, C & D as per their level and intended use. It is provided that all Medical Devices sold in India (except for custom made devices, meant for a particular patient use) should, as a general rule, bear the Indian Conformity Assessment Certificate mark (ICAC) to indicate their conformity with the provisions of this schedule.
Proposed New Clinical Trial Regulations
Additionally, the MDRB discusses clinical trials and Clinical Research Organizations (CROs) in India. If the bill is approved, some high-risk medical devices will require local clinical trials in India in addition to foreign clinical data. In general, more-stringent regulations will apply to CROs and clinical trials.
Recent Updates
In January 2011, the Ministry of Health and Family Welfare issued a notification to amend the
Drugs and Cosmetic Rules with some minor proposals (draft rules) on clinical trial establishments. There are also proposed additions that stress the quality of clinical trials, the need for proper procedures and requirements for skilled CRO staff.
On 11 May 2011, CDSCO released draft guidelines on reporting serious adverse events (SAEs) for medical devices in clinical trials. At present, CROs and medical companies are using multiple different formats to report SAEs. CDSCO is trying to standardize the reporting procedure.
The Health Ministry is planning to amend the Drugs and Cosmetics Rules to introduce certain provisions relating to medical devices and diagnostic reagents. As per media reports, the Ministry will frame draft rules in respect of labelling, manufacturing, shelf life and other matters relating to medical devices and publish them for seeking feedbacks from the stakeholders, before making effective the same.
With an evolving regulatory situation, medical device companies are required to stay up-to-date in order to achieve success in India. The Indian government is working on a comprehensive regulatory framework for the medical device sector. India’s health authorities plan to issue a set of guidelines to define and regulate medical devices as a separate category.
The growth of Indian medical devices industry is driven by a host of factors and is sure to see exponential growth in the coming years. Some market drivers for this industry are:
- An increase in the Gross Domestic Product growth of the Indian economy
- Increase in the Healthcare Expenditure
- Improvement of overall health status
- Changing of demand pattern for medical devices in India due to a rise of lifestyle-related diseases such as diabetes, cardiovascular disease etc.
- Increasing of Medical Tourists
- Increasing of medical infrastructures like hospitals, specialized diagnostic centers, laboratories
In a nutshell, continued flow of investment in private sector infrastructure has resulted in a steady increase in the market for medical equipments and supplies. It is estimated that the market will continue to grow. Further, the recent liberalization of trade and investment laws makes India one of the most promising markets for medical device manufacturers. It is predicted that India will be the most populous country in the world by 2050. India will make its mark as a growing market, potential partner in manufacturing and R&D, and as a preferred destination for clinical trials.
The Indian healthcare industry reached $190 billion in 2020, and, according to the India Brand Equity Foundation, it is expected to reach $370 billion by 2024-2025. This increase is due to growing demand for specialized and higher quality healthcare facilities. The products and services driving this growth include hospitals, medical devices, clinical trials, telemedicine, medical tourism, health insurance, and medical equipment. The industry’s rapid development is fueled by large investments from existing corporate hospital chains and new entrants backed by private equity investors.
Nonetheless, considerable challenges exist in terms of service accessibility and patient care quality. According to the Lancet Medical Journal’s Global Burden of Disease Study, India ranks 145th among 195 countries surveyed. However, India’s healthcare access and quality index score has improved in recent years, increasing from 44.8 (out of 100) in 2015 to 67.3 in 2020.
The impact of the COVID-19 pandemic on India underscores the importance of investing in the healthcare sector. Industry experts believe there will be a significant increase in healthcare spending in India over the next several years, partially spurred by lessons learned from the pandemic. Public spending on healthcare in India stands at just 1.2 percent of GDP, but the Indian government has proposed increasing this to 2.5 percent by 2025, with a special focus on underprivileged populations. As expenditures in the Indian healthcare sector increase, corresponding growth in the medical equipment sector is anticipated.
Although healthcare-related barriers to entry are low compared to other industries, non-tariff barriers and the expansion of price controls on medical devices and the pharmaceutical industry constrain market prospects. Additionally, weak intellectual property protection and enforcement hinder the biopharmaceutical industry’s exports to India. While India’s market has undergone significant economic growth over the last 25 years, it remains difficult to navigate. India tends to be a price competitive market, and the country produces primarily low- to mid-tech products. International competition has also been rigid, and India is often described as a “crossroads” market in the middle of many production and trade routes.
Policy and Regulatory Environment
To ensure quality healthcare, the Indian government increased the list of medical devices covered under the Drugs and Cosmetics Act of 1940, bringing several categories of implantable devices under the provision of the Medical Device Rules (MDR) 2017. Medical devices in India are classified according to the risk to patient health. The current risk classifications are Class A: devices with the lowest risk (e.g., surgical dressings and alcohol swabs); Class B: devices with low to moderate risk (e.g., needle kits and cervical drains); Class C: devices with moderate to high risk (e.g., bone cement, bifurcation stents and catheters); and Class D: devices with high risk (e.g., coronary stents and cardiac catheterization kits).
In July 2017, the Indian government introduced price controls on cardiac stents, capping the selling price up to 70 percent lower than the prevalent market rate. That order was followed by a similar cap on knee implants later in the year. The devices were price capped after inclusion in the National List of Essential Medicines. In January 2020, the Indian government categorized all medical devices (including instruments, implants, and software intended for human or animal medical use) as “drugs,” bringing them under the purview of the Drugs & Cosmetics Act, 1940.
Currently, 37 medical devices are classified as drugs and regulated under the Drugs and Cosmetics Act. Of these, cardiac stents, drug-eluting stents, knee implants, condoms, and intra-uterine devices are included in the National List of Essential Medicines and are subject to price caps. In February 2020, the Indian government levied a five percent ad-valorem health tax on imports of a variety of medical, dental, surgical, and veterinary devices. Several medical device segments (such as orthopedic knee implants) that were previously exempt from customs duties were withdrawn from the duty exemption.
In June 2020, the Department for Promotion of Industry and Internal Trade amended its 2017 Public Procurement Order, giving priority to Indian companies whose products contain 50 percent or more local content. Products with less than 20 percent local content are categorized as “non-local suppliers” and cannot participate in government tenders.
Effective June 2021, the National Pharmaceutical Pricing Authority issued orders to impose price controls on oxygen concentrators in line with the Trade Margin Rationalization (TMR) approach, which is the difference between the price at which manufacturers sell to the trade and the price to patients. National Pharmaceutical Pricing Authority had initially introduced the Trade Margin Rationalization policy for medical devices and drugs in 2018 to help improve patient access to affordable and accessible healthcare.
In June 2021, the Quality Council of India and the Association of Indian Medical Device Industry added new features to the Indian Certification for Medical Devices Scheme of 2016. This new scheme, called Indian Certification for Medical Devices Plus (2021), was designed to verify the quality, safety, and benefits of medical devices and help government agencies identify counterfeit products and falsified certifications. In addition, the new rules eliminated the need for re-approval of manufacturing and import licenses.
In January 2022, the Indian government issued a notification requiring all medical device companies to register their devices with the Central Drugs Standard Control Organization in compliance with a mandatory ISO 13485 certification. This requirement is designed to ensure the safe production and control of medical devices and in-vitro diagnostic products. Previously, medical devices were subject to a voluntary registration scheme. Starting in October 2021, Class A and B medical devices were subject to mandatory registration, and from September 2022, Class C and D medical devices will be subject to mandatory registration. When the mandatory registration period expires in September 2023, the medical device classes will transition to a licensing regime.
In February 2022, the Department of Pharmaceuticals amended the list of medical devices exempted from India’s Procurement Order 2017 to ensure patient access to critical medical technologies not currently produced in India.
| Table: U.S.-India Trade Data for Medical Devices and Equipment ($ million) | |||
| 2019 | 2020 | 2021 | |
| Total Market Size | 8,975 | 10,360 | 11,914 |
| Total Local Production | 2,390 | 4,474 | 3,792 |
| Total Exports | 3,477 | 3,211 | 4,094 |
| Total Imports | 10,062 | 9,097 | 12,216 |
| Imports from the U.S. | 1,694 | 1,418 | 1,887 |
Total Market Size = (Total Local Production + Total Imports) – (Total Exports)
Imports from the United States: U.S. Census Bureau and Global Trade Atlas (HS 90, 3821 and 3822)
Data Sources: Statistical data includes unofficial estimates from trade sources and industry
Leading Subsectors
Medical Devices
The Indian medical device market is estimated at $10 billion and is an attractive export sector for U.S. firms, despite numerous market challenges. Importing nearly 80 percent of its medical devices, India remains highly dependent on foreign suppliers, particularly with respect to higher end equipment such as cancer diagnostics, medical imaging, ultrasonic scans, and polymerase chain reaction technologies. Imports are growing rapidly as world-class hospital groups such as Max, Hinduja Group, Fortis, and Apollo build high-end infrastructure and spur on India’s medical tourism sector, which now contributes $2 billion to the Indian healthcare market.
The Indian government’s newly introduced PLI scheme in medical device manufacturing aims to encourage domestic manufacturing, attract significant investments, and reduce reliance on imports in this industry. Opportunities for U.S. suppliers exist for a range of devices, including Medical and Surgical Instruments; Medical Imaging Equipment; Electro-Medical Equipment; Orthopedic and Prosthetic Appliances; Cancer Diagnostic Solutions; Ophthalmic Instruments and Appliances; Orthodontic Equipment and Dental Implants; Point of Care Testing (POCT) Diagnostic Devices; Digital Healthcare, Health IT, and Telemedicine Services.
Health Insurance
Medical care in India is provided at-cost for immediate payment. Health insurance is gaining momentum, with 15 percent of the population covered by government insurance and two percent by private insurance. Several private insurance companies have entered the market and have petitioned hospitals to provide cashless treatment to subscribers of insurance companies.
Hospital and Medical Infrastructure
Healthcare is provided through primary, secondary, and tertiary care hospitals in India. The former two categories are fully managed by the government, while tertiary care hospitals are owned and managed by either the government or private companies. The private sector’s contribution to healthcare has been growing at a faster pace than that of the government. The medical infrastructure market is growing at an estimated 15 percent annually. Both the government and the private sector are planning several new specialty hospitals, as well as modernization of existing hospitals. India faces a chronic shortage of healthcare infrastructure, especially in second and third tier cities and rural areas. Current estimates are that India will require up to 1.75 million more hospital beds by the end of 2025, which creates an opportunity for foreign companies to set up hospitals in India through FDI. According to industry sources, India’s hospital industry is growing at a compound annual growth rate of 16 to 17 percent and is expected to reach $132 billion by 2023.
Biotech and Biopharma: Biotech and Biopharma are two of the fast-growing segments of the Indian life sciences sector and represent diverse opportunities for U.S. companies. The Indian biotech industry is comprised of about 800 companies, and has a market size of $5-7 billion, constituting approximately two percent of the global biotech industry. India is also a leading destination for clinical trials, contract research, and manufacturing activities in this sector.
Digital Healthcare: Though in its infancy, digital healthcare and telemedicine has expanded rapidly since the onset of the COVID-19 pandemic. People are adapting to new health technologies and intelligent solutions to reduce barriers between hospitals and patients. Telemedicine technology and artificial intelligence will provide significant opportunities for U.S. firms in the coming years. Several major players such as Apollo, AIIMS, and Narayana Hrudayalaya have adopted telemedicine services. The Ministry of Health and Family Welfare, along with NITI Aayog, have recently released official guidelines for telemedicine practices that allow registered medical practitioners to provide remote consultation under the supervision of the National Medical Commission, formerly the Medical Council of India. Healthcare services in rural India are not readily available, with the average rural Indian traveling over 62 miles to receive affordable healthcare at the nearest facility. Rural Indians will benefit from the increased focus on digital healthcare technologies by the Indian government and the private sector as India adjusts to this new service sector in the post-pandemic era.
Refurbished Medical Equipment
India is a high-cost economy for capital equipment, creating significant opportunities for suppliers of refurbished medical and laboratory instruments. These instruments are used as back-up equipment in higher end hospitals, while less sophisticated hospitals and district hospitals consider refurbished medical and laboratory equipment to be optimal due to the lower cost. Some international companies operating in India sell used medical laboratory instruments to their Indian customers. Because Indian hospitals and agents demand continuous service support and spare parts for refurbished instruments and equipment, U.S. companies operating in this area should consider establishing offices in India.
However, there are restrictions on the importation of used medical equipment. Second-hand capital goods with a minimum residual life of five years can be imported by actual users without a license, and importers are required to furnish a self-declaration specifying the residual life of the goods. Refurbished equipment cannot be transferred, sold, or otherwise disposed of within a period of five years from the date of import, except with permission of the Director General of Foreign Trade. Parts, accessories, and tools up to 15 percent of the value of equipment may be imported for maintenance and operation. U.S. firms should remember that valuation of used equipment can result in disputes with Indian customs authorities.
Opportunities
The growing demand for quality healthcare and the absence of matching delivery mechanisms pose both a challenge and an opportunity in the Indian market. The need for equipment and medical consumables is a significant opportunity for U.S. companies, and several leading U.S. manufacturers of hospital equipment and medical supplies have already opened offices in India to serve this growing market.
Growth areas include diagnostic kits, reagents, hand-held diagnostic equipment, and operating room simulations since 50 percent of these products are imported into India. Hand-held, portable diagnostic equipment, including devices for blood sugar and blood pressure testing, is also a fast-growing segment as India has around 45 million diabetics, a number expected to swell to 70 million by 2025.
India has become one of the leading destinations for high-end diagnostic services, with tremendous capital investment for advanced diagnostic facilities. Health insurance and hospital administration are other areas of opportunity for U.S. companies, including the introduction and maintenance of industry standards and the certification of healthcare centers. Construction, financing, and management of specialty hospitals to meet growing demand in India is also a burgeoning opportunity.
Conclusion
The Indian medical devices and supplies market is at a nascent stage and was estimated at US$2.75 billion in 2008. This is about 1.25% of the global medical devices and supplies market of around US$220 billion in 2008. By 2012, India’s medical devices market is expected to nearly double to around US$5 billion. The production of low value medical supplies and disposables is dominated by domestic manufacturers, whereas the high end medical equipment is generally imported. In the future, due to the huge market opportunity in India, more and more foreign medical device companies are expected to explore Indian market for their products.
MEDICAL DEVICES REGULATION & CONTROL
MAHESH PETER,PHARMA ANALYST, BENGALURU
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