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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.

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