India Considering New Device Regulations

India’s medical device market is worth about $3 billion and is ranked as the fourth largest medical device market in Asia, after Japan, China and South Korea. With a population of 1.2 billion people and an ever-growing economy, there is increasing demand for medical devices, especially in the private healthcare zone.

The manufacture, import sale and distribution of medical devices are regulated under India’s Drugs and Cosmetics Act and Rules (D & C Act or DCA). India’s principal regulatory body for implementing the DCA is the Central Drugs Standard Control Organization (CDSCO). In India, the CDSCO is the main regulatory body currently regulating import, sale and manufacture of medical devices that have been consigned as drugs by virtue of Section 3(b) (iv) of the D&C Act. The CDSCO controls standards for drugs, cosmetics, diagnostics and devices and issues licenses to medical device manufacturers and importers. It also administrates regulatory measures, amendments to Acts and Rules and regulates market authorization of new devices/drugs, clinical research in India and standards of imported devices/drugs etc.

Unfortunately, wide-ranging guidelines on the standards and use of medical devices in India are still up in the air. In my numerous business trips to India, I have observed a government that is very slow, predictably bureaucratic and confused about an over-arching strategy for controlling their medical device industry. For example, certain conventional medical devices are still classified as drugs under the DCA, rather than actual medical devices. These include catheters, heart valves, cardiac stents, orthopaedic implants, bone cements and intra-uterine devices. Many other medical devices have not been clearly defined by the DCA.

Only certain products require medical device registration in India. Under CDSCO's current system, products requiring medical device registration in India need approval from the Drugs Controller General of India (DCGI). There are application fees, and the DCGI may require clinical testing in India or request information on clinical trials performed abroad. Before a medical device can be sold in India, both a Registration Certificate and an Import License are required. Again, from personal experience, CDSCO can act as a roadblock in many cases between DCGI and the Ministry of Health. The medical device manufacturer becomes caught in the middle. The process is also slow and the rules seemingly change “on the run.” There is a huge void of authority in this area of registration, clinical trials and regulatory affairs—all of these relationships (and behaviors) between CDSCO and DCGI still have not been clearly defined.

Current Product Registration Submission Documents

To give an idea of the extensive documentation required to for medical device registration (yes, just registration) in India, at least the following documents are required:

  1. Cover letter that specifies whether the registration application is being submitted for the first time or for re- registration.
  2. Authorization Letter listing the name and designation of the person authorized to sign all legal documents on behalf of the manufacturer.
  3. Form 40 for the issuance of the Registration Certificate. Form 40 can be submitted by the manufacturer or through an authorized agent in India.
  4. Power of attorney provided by a manufacturer to its agent in India, authenticated either in India or in the country of origin.
  5. Schedule D(I) and D(II). Schedule D(I) outlines the particulars of the manufacturer and manufacturing premises such as the name and the address of the premises. Schedule D(II) or the Device Master File (like a Device Master Record) is an executive summary of the medical device to be registered and contains information on the device, its sterilization requirements, Bill of Material, packaging, etc.
  6. The Plant Master File (also like the Device Master Record) contains information about the product and control of the manufacturing process at the manufacturing site.
  7. Wholesale license along with a Free Sale Certificate or Certificate of Marketability for each device issued by any of the Global Harmonization Task Force (GHTF) member countries, e.g., the United States of America, Canada or Japan.
  8. Manufacturing License or Plant Registration Certificate issued by the National Drug Regulatory Authority or equivalent.

As you can see, this is a rather encumbering list of “deliverables”. As you probably guessed, it is rather advantageous to have an Indian company represent you when going through this process…an insider, if you will.

Inspections of Foreign Manufacturing Facilities

Like ANVISA (See “Passing Brazil’s Inspections to Take Product to Market,” BONEZONE January 2013), CDSCO has recently begun inspections of manufacturing facilities in foreign countries, such as Italy, to help ensure the quality of medical devices imported into India. Once initial pilot projects are successful, the CDSCO will introduce auditing and inspection of manufacturing in more countries in the near future. It is purported that these inspections will be closely aligned with ISO 13485, and the Indian Government will most likely charge the interested medical device manufacturer to inspect the Quality Management System, e.g. in the U.S., Canada, Italy, Japan, etc.

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 geared toward establishing and maintaining a national system of controls for the quality, safety and availability of medical devices in India. The bill was intended to be fully implemented by December 31, 2009 as a Parliament Act. However, it was not passed by India’s Council of States and was subsequently abolished. Recently, though, there has been talk of reintroducing the MDRB in late 2013 or early 2014.

If enacted, the MDRB will oversee all medical devices throughout India. Companies that want to sell devices in India or manufacture products locally (for sale in India) will have to comply with the design, manufacturing, packaging, labeling, import, sale, use and disposal requirements of the MDRB. The bill will increase the list of products requiring medical device registration in India, as well.

Proposed Classification System for Medical Devices

If the MDRB is implemented, a risk classification system for medical devices will be set up comprising Classes A, B, C and D. This classification is consistent with the definition and guidance from the Global Harmonization Task Force (GHTF), as well as the European Union (EU) medical device directives.

  Class  

  Risk Level

  Device Examples

  A

  Low Risk

  Thermometers/Tongue Depressors

  B

  Low Moderate Risk  

  Hypodermic Needles/Suction Equipment       

  C

  Moderate High Risk  

  Lung Ventilators/Bone Fixation Plates

  D

  High Risk

  Heart Valves/Implantable Defibrillators    

 

Influences on Regulatory Structure Development

India has not modeled its regulatory system after FDA. The Indians consider the approach to the cGMP-Quality System Regulation too costly to apply in India and too complex for Indian industry to adopt without many questions to answer and cultural adjustments to abide by. India is leaning more toward a European-type approach to regulations. For reasons of cost and existing infrastructure, India is attracted to the flexibility of the EU’s structure with its reliance on a de-centralized network of private sector conformity assessment bodies appointed by the Competent Authority of each member state, e.g. the European Union.

Use of Notified Bodies

India will consider the use of private third-party conformity assessment bodies (referred to as “Notified Bodies” and similar to Notified Bodies under the European Union or EU medical device directives) to carry out conformity assessments. They would assess medical device manufacturing sites on the basis of the ISO 13485 quality management system standard and submit findings to the regulatory authority (CDSCO or CDA) to make a decision on granting a manufacturing license. This would apply to medical device classes IIa, IIb and III (B, C, D above).


Standards and Road Blocks

India will move toward the use of international standard ISO 13485: 2012 quality management systems for medical devices, published by the Bureau of Indian Standards (BIS) as Indian national standard IS 15579: 2005. (Note: BIS has reportedly stated to industry that these standards are identical except for a national foreword and minor editorial changes, e.g., punctuation). Unlike Europe or Global Harmonization Task Force guidance, however, compliance with IS 15579 may be made mandatory. Additionally, a list of EU-harmonized product and process standards and list of BIS standards were exchanged, and industry will provide comments suggesting which out of these should be considered relevant. That being said, Officials in the CDSCO have expressed concerns that ISO 13485 may be insufficiently specific for manufacturers or for external auditors. Industry has sought to explain that this approach is necessary to accommodate the diversity in medical devices, technologies and processes and that more detailed specific guidance is impractical. GHTF guidance documents may be used to supplement the standard.

Like the U.S. and EU systems, quality assurance, risk management and quality management systems will be the responsibility of the manufacturer, who must obtain certification from a notified body for medium and higher risk class devices. The Notified Bodies would also conduct periodic surveillance audits of the manufacturer’s facilities and systems. As I said, the cost of such certification and surveillance will be borne by manufacturers. At this time, however, many in the government feel that India is not fully ready for such a system because it would be viewed as cost-prohibitive by many smaller Indian manufacturers—another mixed message.

Conclusion

The production of low-value medical supplies and disposables is dominated by Indian manufacturers, whereas the highly-critical medical devices are generally imported. In the future, due to the huge market opportunity in India, more and more foreign medical device companies are expected to explore the 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.

Continued flow of investment dollars by foreign firms has resulted in a steady increase in the market for medical equipment and supplies. The market will continue to grow beyond the boundaries of expectation. It is predicted that India will be the most populous country in the world by 2050, and will make its mark as a growing market, potential partner in manufacturing and Research/Development and as a preferred destination for clinical studies.

 

John Gagliardi has had success over the past 43 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. John can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

MidWest Process Innovation, LLC
www.midwestprocessinnovation.com

 

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