NDCTR 2019

This product will be reviewed by the Biological Division of the CDSCO. All the CMC (Chemistry Manufacturing Control), Stability data and pre-clinical GLP Toxicity data should be compiled as per the NDCTR 2019 requirements and submitted to the authorities for review.

MDR 2017:

Since there is device component in the product additionally device design inputs, stability data, Data on the manufacturing process and biocompatibility should be gathered to guarantee the operation and safety of the combination product.

All devices as per Indian MDR 2017, that have animal, or human origin material of construction are accounted as high-risk devices and should fall under Class ‘C’ or ‘D’.

NGSCR 2017:

Since the cell device has the cellular components the NGSCR 2017, should also be referred to. All the requirements for safety toxicity studies to de-risk the product as much as feasible before the request for human testing/use is filed with the regulatory authorities.

Manufacturing Setup:

To manufacture the Cell-Device, establish a manufacturing facility which follows the principles of Good Manufacturing Practices or collaborate with a contract manufacturing organization (CMO) that has infra-structure that complies with the Indian cGMP standards.

Establish an Indian agent (if applicable):

If the Cell-Device is manufactured by a foreign manufacturer, appoint an Indian agent or authorized representative to communicate with CDSCO and other regulatory authorities.

Preclinical Testing:

Preclinical studies should be performed to evaluate the safety, performance, and efficacy of the Cell-Device. These studies involve in vitro and animal studies to obtain data on the cell-device’s performance and potential risks.

All toxicity studies must be performed in GLP (Good Laboratory Practices) Certified Laboratories. The performance or Proof of Concept (PoC) studies can be performed in research and development facilities.

Clinical Trials:

Pilot and pivotal Clinical trials are required for cell devices since they are a novel concept and do not have a precedence to establish the safety and effectiveness in humans. The cGood Clinical Practice (GCP) guidelines [ISO 14155 and effective ICH GCP (E6)] must be followed while performing clinical trials with adherence to the protocols approved by the CDSCO and the Ethics Committee.

If the product is invented by an innovator outside of India, as per Indian regulations the first in human studies are not permitted in India, so there should be prior clinical data from the country of origin or from outside of India before the Phase 2 (pilot study) is permitted in India.

The Phase 1 (feasibility-First in Human) studies for products innovated and manufactured in India are permitted in India as per Indian regulations.

Ethics Approval:

Before conducting clinical trials, ethics committee approval should be obtained from an Institutional Ethics Committee (IEC) or an Independent Ethics Committee (IEC). Ethical approval is required to make sure that the clinical studies are carried out ethically and in accordance with global ethical principles that have their origin from the World Medical Association’s Declaration of Helsinki and international and local regulatory requirements.

All such Ethics Committee overseeing such clinical studies should be registered with the CDSCO and should have at least two stem cell scientists as part of the committee reviewing the stem cell research proposals.

Regulatory Approval for Import/Manufacturing for Testing and for Conducting the Clinical Trial:

Submit an application to the CDSCO for regulatory approval for Import/Manufacturing for Testing and for Conducting the Clinical Trial:

The application should include all technical documentation, safety and performance data, clinical data (if applicable), and any other required information, clinical trial documents and regulatory documents from the participating sites. The application will be reviewed by the CDSCO and either grant approval or request additional clarifications before finalizing the approval process.

It should be kept in mind that in case of a product developed outside India, the first in human studies are not permitted in India.

Clinical Trial Registration:

The study should be prospectively registered with the Clinical Trial Registry India (CTRI) https://ctri.nic.in/Clinicaltrials/login.php before the patient enrolment begins.

Technical Documentation:

After the completion of the trials, the technical documentation is updated with the final specifications, labelling, manufacturing details, quality control processes, performance data, risk analysis, safety data and other required information by the CDSCO. The commercial application is submitted for market authorization.

Import License (if applicable)/Manufacturing License for Sales and Distribution:

In case if the Cell-Device is not manufactured in India and requires importation, an import license must be obtained from the CDSCO through the Authorized Indian Agent.

Registration Certificate:

The Registration Certificate should be obtained from CDSCO as per the Indian Drugs and Cosmetics Act.

Post-Market Surveillance:

Once the Cell-Device is in the market, post-market surveillance system should be implemented to evaluate the product’s performance, safety, and efficacy. FFAny adverse events to be reported to the CDSCO as required by regulations.

As per NDCTR 2019, the Cell device will always remain a new entity and the post marketing surveillance reports as PSURs (Periodic Safety Update Reports) should be submitted to CDSCO every six months for the first two years and thereafter annually. F

Marketing and Distribution:

Develop a marketing and distribution strategy for Cell-Device in India. Identify potential distributors, establish partnerships, and comply with advertising and promotion regulations.

*It is important to note that the processes and requirements for bringing a Cell-Device into the Indian market may vary depending on the classification and characteristics.