The Medical Device Regulatory Scenario in India: Present and Future

30th June 2016 (Last Updated July 18th, 2018 11:46)

Abhijit Vaidya, Cipla Ltd., describes the medical device landscape in India

The Medical Device Regulatory Scenario in India: Present and Future

India is one of the largest countries in Asia, noticeably seeing a rapid growth in the medical device market. With an increase in awareness, public trust in the use of medical devices has risen. In the past, the sale of medical devices was permitted by the Central Drugs Standard Control Organisation (CDSCO). However, with the regulatory scenario in India changing, processes are becoming much more streamlined.

Current Regulation

In India, a medical device is defined based on its internal or external use for diagnosis, treatment, and prevention of a disease or disorder. While certain products are considered a device, others are categorised as products for which regulation related to drugs are followed. Under current regulation, there are approximately 30 categories of devices, some of which include:

  • Disposable syringes
  • Needles
  • Disposable perfusion sets
  • Cardiac and drug eluting stents
  • Catheters and IV cannulas
  • Bone and dental cements
  • Prosthetic replacements
  • Heart values
  • Intra ocular contact lenses
  • In-vitro diagnostic devices for HIV, HBSAG and HCV

Furthermore, devices apart from those listed above, if approved by any foreign regulatory body (USFDA, EMEA with CE marking, ANVISA or TGA), can be registered faster with the procurement of an import license meaning less paper work.

Procedure of device registration

Typically, registration for medical devices that fall outside the category listed above can take around six to nine months after applying. Once the registration has been approved, the manufacturer must obtain a No Objection Certificate from the Drug Controller General of India (DCGI). After a product is registered in India, the license provided is valid for a period of three years and later a renewal is required to be submitted at least six months in advance. CDSCO requires form 41 along with import license form 10 to be submitted with the application under the current requirement. Upon receipt of the import license, the following mandatory documents must be prepared and kept ready with an Indian liaison officer for clearing imported goods:

  • Signed Invoice
  • Packing list
  • Bill of Lading or Delivery Order/Airway Bill
  • GATT declaration form duly filled
  • Importers/Clearing House declaration
  • Letter of Credit/Bank Draft
  • Insurance document
  • Import license
  • Industrial License
  • Test report in case of chemical
  • Catalogue, technical write up, literature in case of machine
  • In case of part of machine then separate split up values
  • Certificate of Origin

All medical devices that fall under regulation have to undergo single or multiple clinical trials to prove its performance and quality in comparison to products currently available in the market. In the event a sponsor is conducting a multi-centric, multi-country trial - where India is one of the participating countries -data is accepted on a case-by-case basis where a trial waiver may be granted. Additionally, Indian regulators require a significant amount of data be generated, and that the product be approved in the country of origin prior to applying for registration in India.

Regulatory Framework

Each company that intends to conduct a medical device trial in India has to undergo a three-step review process. A company should prepare a device master file and a plant master file that should include the following information:

  • The end-to-end manufacturing of the device
  • Form 44 application for the conduct of clinical trial, and
  • Fees for review of proposal to conduct the clinical trial

If there are any queries or missing documents, a letter from the DCGI will be sent for clarification. There is a pre-screening check-list for submission of documents available on the CDSCO website for reference. After the medical device file clears the pre-screening committee, it goes for further review to a medical device advisory committee. The review process usually takes 45-90 days, depending on the complexity of the device trial and all non-clinical and clinical data submitted previously.

Abhijit Vaidya picture

If there are no queries or missing documents, the sponsor company will then be invited to present a plan of how they intend to conduct their clinical trial. This presentation must be done before the medical device advisory committee (MDAC). If the MDAC forms a positive opinion, the file is then shared with an administrative and technical committee, all under the supervision of the DCGI. This committee is responsible for checking the eligibility of the participating investigators, and their experience on conducting research on a similar type of device. After receiving a No Objection Certificate (NOC) from the DCGI, a clinical trial can proceed. The sponsor (or their business partner) conducting trials in India is obligated to update the DCGI on the status of their trial on an annual basis. After successfully completing the trial, the analysed data has to be submitted to the DCGI for further review. This review usually takes around three to six months based on the urgent medical need of the device. If the data is deemed acceptable to the DCGI, a marketing authorization is provided for a period of three years.

Future of Medical Device Regulation

There are a couple of changes that have been recommended by the committee formed under the DCGI for improving device regulations in India. One includes proposals for changes to be made in good manufacturing practices. Additionally, a proposal has been put forward for the Drugs and Cosmetic Act of India to be amended as the Drugs, Cosmetics and Medical Devices Act, which is under discussion in the Indian parliament. This law will regulate the manufacture, distribution, sale, import, and export of drugs, cosmetics and medical devices. What's more, it is proposed the definition of a medical device be revised and classified as any instrument, apparatus, appliance, implant, material or other article used specially for human beings or animals for one or more of the specific purposes of:

  • Diagnosis, prevention, monitoring, treatment or alleviation of any: disorder/disease or injury/handicap
  • Investigation, replacement or modification or support of the anatomy or of a physiological process
  • Supporting or sustaining life
  • Disinfection of medical devices
  • Control of conception

There is a proposed change on the classification devices based on associated risk:

  • Class A - Low Risk (example: Thermometer)
  • Class B - Low moderate risk (example: Needles)
  • Class C - Moderate-High risk (example: Ventilator, dental or bone fixing material)
  • Class D - High Risk (example: Stents OR Heart valves)

There are also changes proposed in the drug and cosmetic act to defining conditions for:

  • Assessment of confirmatory
  • Import or manufacturing of custom made devices
  • Reporting of adverse events, post marketing surveillance and recall
  • Approval of laboratories, institutions or bodies for carrying out conformity
  • Overseas inspections
  • Methods of testing or analysis to be employed in determining whether medical device is of standard quality

Conclusion

Regulatory bodies in India are in its infancy and evolving slowly in line with FDA and EMEA regulations under the supervision of DCGI. There is frequent training and amendments in regulations as processes are developed to global standards. There is regular modification seen within a short period of time. For a foreign company, it is always advisable to have a business partner based out locally for a speedier registration of your device in India. With a rising target population, increasing awareness and clear regulation, India will always be a lucrative market.

 

 

*Abhijit Vaidya is the Clinical Trial Leader India Operations at Cipla Ltd. The views expressed in this article are solely those of the author's based on information available in public domain. Vaidya's views do not necessarily reflect policy at Cipla