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$1,243 billion and rapidly getting bigger . The GDP growth reached 9% in the year to March 2008. The 2010-11 budget extended the coverage to another 20% of the Indian population covered by the National Rural employment Guarantee Act (NREGA) programmes, who have worked for more than 15 days during the preceding financial year.Budget 2010-11 also allocated US$ 2,920 million under the National Rural Health Mission (NRHM), an increase of 15% over the previous year.
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 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:
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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 BISin 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  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 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.
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.
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.
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.