India: Import, Distribution And Registration Of Medical Devices In India - A Regulatory Roadmap

A Regulatory Roadmap

This article has been written by Mr. Vinay Vaish, Partner, Vaish Associates Advocates with Mr. Juvraj Singh Bindra, Associate, Vaish Associates Advocates

INTRODUCTION

From being a non-existent industry in the beginning of the 20th century to evolving into a buoyant market, the Indian Medical Device industry has shown remarkable variation in its synthesis of demand and supply to now be worth a staggering USD 2.5 Billion industry, approximately.

Paradoxically, even though this evolving industry is expected to accelerate its growth in times to come, there is no specific substantive law in India which regulates the import and distribution of medical devices, nor is there any official definition of the term "medical device", thereby leaving this industry, largely unregulated, including standards of safety and quality.

As a solace certain medical devices have been given a deeming categorization as "Drugs" and hence they were ipso-facto made to fall under the purview of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1950. The regulatory body responsible for the enforcement of the DCA and the DCR is the office of Drugs Controller General of India.

The Ministry of Health and Family Welfare has already issued a list of medical devices that have been categorized as Drugs. Recently, vide notification no. 29/Misc./5/2014-DC dated 9th July, 2014 this list was further expanded whereby fourteen (14) medical devices were classified as Drugs. The said notification has further clarified that any device that does not appear in the said list of Drugs, does not require any registration certificate or other approvals from the regulating authority.

In view of the present-day regulatory framework the functions of import, distribution, manufacture, and sale of Medical Devices (notified as Drugs) require procurements of licenses or permissions and procedural compliances, as provided in the DCA. The DCR more specifically elaborates the procedure as well as provides the formats of various "Forms", to be filled up in order to procure such licenses or permissions, as the case may be.

The regulatory procedure for registering, licensing and importing of medical devices may vary according to their class. The underling objective of this article is to provide a road map of the regulatory framework for registration, import and distribution of medical devices in India.

REGISTRATION OF MEDICAL DEVICE

Procedure For Registration Of Medical Device.

The first step is that the Manufacturer is required to register:

  1. The premises where the said Drug is being or will be manufactured and
  2. Thereafter the Drug manufactured by the Manufacturer which is intended to be imported into and used in India, itself is to be registered in accordance with the DCR.

As per rule 24A of the DCR the procedure to make an application for issue of a Registration Certificate is as under:

  1. An application for issue of a Registration Certificate shall be made to the Licensing Authority in Form 40.
  2. The application has to be made:

    1. Either by the Manufacturer himself, having a valid whole sale license for sale or distribution of Drugs under the DCR; or
    2. By the Manufacturer's agent in India, either having a valid license under the DCR to manufacture for sale of a drug or having a valid whole sale license for sale or distribution of Drugs under the DCR.
  3. In case the Manufacturer authorizes his agent to make the application, then the authorization by the Manufacturer to his agent in India has to be documented by a power of attorney executed and authenticated either in India before a First Class Magistrate or in the country of origin (in case the Manufacturer is a person/entity who is based outside India) before such an equivalent authority and which has to be certified by the Indian embassy of the said country and the original of the same shall be furnished along with the application.
  4. Fee for registration of premises of the Manufacturer: A fee of USD 1500 or its equivalent in Indian rupees has to be paid along with the application in Form 40 as registration fee for registration of premises meant for manufacturing the Drugs intended for import into and use in India.
  5. Fee for registration of Drugs meant for import: A fee of USD 1000 or its equivalent in Indian rupees has to be paid along with the application in Form 40 for the registration of a single drug meant for import into and use in India and an additional fee of USD 1000 or its equivalent in Indian rupees for each additional drug, if any.
  6. Undertaking of conformity has to be given by the Manufacturer with respect to product standards, safety and effectiveness requirements and quality systems in the country of origin.
  7. The applicant shall be liable to pay a fee of USD 5000 or its equivalent in Indian rupees for expenditure as may be required for inspection or visit of the manufacturing premises or Drugs, by the Licensing Authority or by any other persons to whom powers have been delegated in this behalf by the Licensing Authority under Rule 22. The fee for inspection of the manufacturing premises can be paid either through a challan in the Bank of Baroda or through ECS.
  8. The applicant shall also be liable to pay testing fees directly to a testing laboratory approved by the Central Government in India or abroad, as may be required for examination, tests and analysis of the drug.

The dossier which comprises of several forms is to be submitted by the applicant for registration of the medical device, which shall include the following information:

Applicant Details Product Information Regulatory Status Master File (Details of good manufacturing practices employed by the Manufacturer to ensure quality of the device) Devices containing medicinal product Post Market Surveillance
  1. Applicant company's name, address and contact number.
  2. Name and address of the foreign manufacturer (manufacturing premises).
  3. Copy of the plant master file
  4. Name and address of the local authorized representative
  5. Name and address of the importer.
  6. Local manufacturer, if any processing is being done in the country.
  1. Proprietary/ brand name.
  2. Brief description of the device.
  3. Category of device.
  4. Intended use and method of use.
  5. Medical specialty in which the device is used.
  6. Qualitative and quantitative particulars of the constituents.
  7. Brief description of the method of the manufacture and specification of the materials used.
  8. Contraindications, warnings, precautions potential adverse events and alternate therapy, wherever applicable.
  9. List of accessories and other devices or equipment to be used in combination with the device. Other descriptive information, including accessories packaged with the product.
  10. Variations in shape, style or size of the device, if applicable.
  11. Labeling details conforming to the DCR.
  12. Physician manual and promotional literature (literature insert) in English.
  13. Packaging description including pack sizes.
  14. Recommended storage conditions.
  15. Summary indications of any reported problems.
  16. Details of standards to which the device conform along with the copy of the standard.
  1. Approval of the product from any other regulatory agency (Separate evidence for the approval from each agency)
    1. US FDA clearance/ approval.
    2. EU medical device directive (CE Certificate).
    3. Australia/ Canada/ Japan approval.
    4. Approval in any other country.
  2. List of countries where the device is being sold.
  3. List of countries where device is withdrawn from sale with reasons, if any.
  4. Copy of ISO/EN Certification if any for the manufacturing facility.
  1. Component/ material used.
  2. Device master file.
  3. Manufacturing process/flow chart.
  4. Quality assurance procedures/ process controls.
  5. Final product testing or design inputs/outputs verification, if applicable.
  6. Functionality test protocol and report, if applicable.
  7. Risk assessment as per ISO 14971.
  8. Sterilization process and validation/ verification.
  9. Stability data or statement of established stability of material used as applicable.
  10. Shelf life of the device.
  11. Biocompatibility and toxicological data, wherever applicable.
  12. Device GMP Certificate.
  1. If device incorporates a medicinal product, which is liable to act upon the body with action ancillary to that of the device, data on the safety, quality and usefulness of the medicinal substance used.
  2. Data on compatibility with medicinal products, if device intended to deliver medicinal products.
  3. Clinical data and published articles, if any.
  4. Batch release certificate for products incorporating any medicinal substance or substances of animal origin.
  5. For devices not approved for marketing in the country of origin, the applicant shall submit reports of clinical trials, details of sales, certificates of satisfactory use from the medical specialists about the use of the device and details of product complaints, if any.

    (Medical devices with prior approval from any of the recognized regulatory authorities will be subjected to an abridged evaluation and only a summary of all the studies and information described above is to be submitted)
  1. Procedures for distribution of records.
  2. Complaint handling
  3. Adverse incident reporting
  4. Procedure for product recall

Grant Of Registration Certificate

On receipt of an application for registration of the medical device the Licensing Authority as per rule 27A of the DCR shall, on being satisfied that:

  1. The application is complete in all respects and the information specified in Schedules D-I and D-II are in order; and

If granted, the conditions of the Registration Certificate, will be observed, issue a Registration Certificate in Form 41.

Duration Of Registration Certificate

As per rule 28A of the DCR a Registration Certificate is valid for a period of 3 (three) years from the date of its issue.

IMPORT LICENSE FOR IMPORT OF DRUG (MEDICAL DEVICE)

Procedure For Obtaining Import License

The importer of the medical device, after acquiring an IEC number from the office of the Director General of Foreign Trade, shall make an application for the import of the Drugs contained in Schedule X of the DCR. Otherwise, the application has to be made in Form 8.

Rule 24 of the DCR deals with the procedural requirements for obtaining an Import License.

  1. An application for an Import License shall be made to the Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Government of India, in Form 8, accompanied by a license fee of Rs. 1,000/- for a single drug and an additional fee at the rate of Rs. 100/- for each additional drug
  2. The application may be made either:

    1. By the Manufacturer himself having a valid wholesale license for sale or distribution of Drugs under the DCR, or
    2. By the Manufacturer's agent in India either having a valid license under the DCR to the manufacture for sale of a drug or having a valid wholesale License for sale or distribution of Drugs under the DCR.
  3. The authorization by the Manufacturer to his agent in India has to be documented by a power of attorney executed and authenticated either in India before a First-Class Magistrate, or in the country of origin (in case the Manufacturer is a person/entity who is based outside India) before such an equivalent authority and which has to be certified by the Indian embassy of the said country and the original of the same shall be furnished along with the application.
  4. The application for an Import License has to be accompanied by a copy of the Registration Certificate issued in Form 41 issued under Rule 27A.

Conditions To Be Satisfied For Grant Of Import License

As perrule 25A of the DCR before granting the Import License, the Licensing Authority shall have regard to–

  1. Whether the premises, where the imported substances will be stocked, are equipped with proper storage accommodation for preserving the properties of the Drugs to which the Import License applies.
  2. Details of the occupation, trade or business ordinarily carried out by the applicant

Licensing Authority on being satisfied that the conditions of the Import License have been complied with issue an Import License in Form 10.

Duration Of Import License

As per rule 28 of the DCR an Import License, unless suspended or cancelled, shall be valid for a period of 3 (three) years from the date of issue

SALE AND DISTRIBUTION OF DRUG (MEDICAL DEVICE)

Procedure For Obtaining License For Sale Of Drugs

Rule 59 of the DCR deals with the procedure for obtaining License for sale of Drugs in India.

  1. An application for the grant or renewal of license to sell, stock, exhibit or offer for sale or distribute Drugs, shall be made in Form 19.
  2. A fee of Rs. 150/- has to be paid for a duplicate copy of a license to sell, stock, exhibit or offer for sale or distribute Drugs, if the original license is defaced, damaged or lost.

Procedure For Renewal Of License For Sale Of Drugs

An application for renewal of a license to sell, stock or exhibit or offer for sale or distribute Drugs, after its expiry but within six months of such expiry shall be accompanied by a fee of Rs. 1500/- plus an additional fee at the rate of Rs. 500/- per month or part thereof in Form 19.

Sale At More Than One Place

As per Rule 62 of the DCR, if Drugs are sold or stocked for sale at more than one place, separate application has to be made and a separate license will be issued in respect of each such place of sale.

Duration And Renewal Of License For Sale Of Drugs

As per Rule 63 and 63A of the DCR an original license or a renewed license to sell Drugs, unless sooner suspended or cancelled, will be valid for a period of 5 (five) years from the date of grant or renewal of the certificate.

In case an application for renewal of the license is made before its expiry or if the application is made within 6 months of its expiry, after payment of additional fee, the license will be in force until orders are passed on the application.

If the application for renewal is not made within 6 months of its expiry date, it will be deemed to have expired.

Labelling And Packaging Requirements

Rule 95 of the DCR requires that no Drug should be sold or distributed by a person unless it is labelled in accordance with the DCR. Rule 96 of the DCR further deals with the manner of labelling of Drugs.

CONCLUSION

Although a major chunk of this emerging industry comprises of products imported from foreign shores, the contribution to the growth of this industry by the products manufactured in the domestic market is mounting in a large measure.

Successive regimes in their bid to win the confidence of domestic and foreign manufacturers and investors have shown keen interest to provide specific legislation to regulate this budding industry. Despite all its infirmities the market displays dynamics of a lucrative opportunity for both manufacturers and investors.

DEFINITIONS AND ABBREVIATIONS

S.No. Term Definition/ Abbreviation
1 Drug means a Medical Device(based on the deeming categorization under the DCA)
2 Drugs and Cosmetics Act, 1940 DCA or the Act
3 Drugs and Cosmetics Rules, 1945 DCR or the Rules
4 Electronic Clearance System ECS
5 Food and Drugs Administration FDA
6 Good Manufacturing Practices GMP
7 Import Export Code IEC
8 Licensing Authority Means the office of Drugs Controller General of India.
9 United States US
10 World Health Organisation WHO

© 2014, Vaish Associates, Advocates,
All rights reserved with Vaish Associates, Advocates, 10, Hailey Road, Flat No. 5-7, New Delhi-110001, India.

The content of this article is intended to provide a general guide to the subject matter. Specialist professional advice should be sought about your specific circumstances. The views expressed in this article are solely of the authors of this article.

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Authors
Vinay Vaish, Partner, Vaish Associates Advocates
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