RFP Invited for DCGI Test License for HIV Self-testing kits

Follow us @ngobox

RFP - DCGI Test License for HIV Self-testing kits

About the Organization:

PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, finance, technology, advocacy, and dozens of other specialties, PATH develops and scales innovative solutions-including vaccines, drugs, devices, diagnostics, and approaches to strengthening health systems worldwide.

Project Background:

The STAR India HIV Self-Testing project has been designed as an extension of the HIV Self-Testing Africa (STAR) Initiative, funded by UNITAID. STAR Initiative Extension is implemented in seven countries (Nigeria, Tanzania, Mozambique, Cameroon, Uganda, India, and Indonesia) by a consortium of partners (PSI, PATH, Jhpiego, WHO, and ILO). PATH implements in India, Indonesia, and Uganda. In India, PATH will work with different partners to implement the HIV Self-testing (HIVST) among the “at-risk” population including key population and their sexual/injecting partners in collaboration with NACO.

Purpose of the RFP: To hire an agency to process the DCGI test import license as per the protocol for HIVST test kits.

Scope of Work:

Prior to DCGI application

• To facilitate meeting(s), if needed between CDSCO (DCGI) and PATH to understand the expectations/requirements associated with conducting HIV Self Testing Project (Study) in India.
• Follow-up with CDSCO officials for resolution/ clarification of any outstanding queries/issues. At the end of this meeting, there should be clarity in terms of the optimal regulatory strategy to be adopted to get approval for conducting the Study in India.

DCGI application

• Provide a list of documents to PATH to be submitted at CDSCO for study application
• Compile the regulatory dossier for submission ensuring compliance with all necessary submission requirements. (Study protocol and other key study related documents to be prepared and provided by PATH)
• Submit the regulatory dossier at CDSCO assuming the role/responsibility of regulatory sponsor for the study.
• Be responsible for payment of necessary application fee for DCGI submissions.
• Actively follow up with CDSCO office to ensure any initial queries on adequacy of dossier are collected and responded to in an expeditious manner.
• Assist PATH in preparation for Subject expert committee (SEC) review
• Submission of any document at CDSCO required post submission for SEC meeting etc.
• Assist PATH in answering and submission of queries arising out of SEC meeting Resubmission and approval of any amendments to key study documents arising out of initial study application
• Actively track the movement of application in CDSCO until the issuance of no objection certificate (NOC) for the clinical trial application
• Submission of any amendments to protocol and submission of application for inclusion of additional sites, Change in PI, change in site address etc.

Other

• Facilitate obtaining import/export license as applicable for oral (OraQuick) and blood based (Insti) and be responsible for importing / custom clearance logistics.
• Be responsible for managing and distribution logistics for study products (test kits) to study sites.
• Purchase necessary insurance policies for the study as required under the CDSCO guidelines.
• Be responsible for registering the study on clinical trial registry of India (CTRI)
• Be responsible to guide the project team on all applicable regulatory/ ethics compliances by PI in the event of any adverse events
• Responsible for keeping PATH team abreast of legal and regulatory compliance requirements for the study as per the requirements.

Overall Qualifications

Provide a narrative on your technical approach to accomplish the Scope of Work and Deliverables per section IV, including:

• Registered DCGI regulatory agency
• Experience in dealing with DCGI on import license
• Experience of facilitating DCGI Subject Expert Committee meeting and response to their queries
• Profile of relevant experience and examples of DCGI regulatory related work.
• Number of years in business.

Contract Requirements

The following is a list of some of the contractual requirements of this solicitation, which the selected applicant should be prepared to agree to:

• PATH agreement template with standard Population Services International (PSI) flow-through terms and conditions and branding requirements.
• Terms and conditions requiring compliance with Government of India laws and regulations.

PATH contacts:

• Procurement Contact: Sushil Pandey (spandey@path.org)
• Technical/Program Contact: Vaishnavi Jondhale (vjondhale@path.org)

Confirmation of interest:

• Please send a statement acknowledging receipt of this solicitation and your intent to respond or not respond no later than October 19, 2020. Send the confirmation to the contacts listed above.

Proposals due: October 26, 2020

• Completed proposals should be submitted by email to the contacts listed above. The subject line of the email should read: “RFP – STAR India HIV Self-test project – Bidder Company/Agency name.”

For more information please check the Link