The COVID-19 pandemic has literally brought the world to a standstill. Large scale infections have resulted in lockdowns across the globe. At this critical juncture, testing continues to remain the most important step to get a grip over the situation. The situation in India is no different. With an upsurge in the number of COVID-19 cases in India, the need for largesse testing has become paramount. Low availability of test kits remains a cause of great concern to the government and healthcare practitioners. This is compounded by our massive populace, given the quantity that is required in the current scenario. This lack of availability of test kits is primarily because India does not have adequate indigenous manufacturing units of COVID-19 test kits and relies heavily on imported kits.
From a regulatory standpoint, such kits fall under the category of ‘in-vitro diagnostic’ kits under the Drugs and Cosmetics Act, 1940 (D&C Act) read with the Medical Devices Rules, 2017 (MD Rules) and are regulated as ‘medical devices’.
Regulatory Pathway for Obtaining Manufacturing Licences for Test Kits
If any entity is desirous of developing and manufacturing a COVID-19 test kit in India, it would be required to go through the following regulatory pathway before it can start commercial manufacturing of its kits:
1. Step 1: Test Licence
Process: As per Rule 31 of the MD Rules, a licence is required to be obtained from the Drugs Controller General of India (DCGI) for manufacturing even small quantities of a medical device for the purposes of clinical investigations, test, evaluation, examination, demonstration or training. This licence enables the developer to manufacture prototypes of the testing kit and carry out tests on the same. Such licence is applied for in Form MD-12 and is issued in Form MD-13. An application for grant of a Test Licence is to be accompanied with the following information:
- brief description of the medical device, including intended use, material of construction, design and an undertaking stating that the required facilities, including equipment, instruments, and personnel, have been provided to manufacture such medical devices;
- list of equipment, instruments;
- list of qualified personnel;
- copy of manufacturing licences issued under the MD Rules, if any; and
- approval letter authorising to undertake research and development activities issued by any Government organisation, if any.
Timelines: Issuance of such licence in Form MD-13 by DCGI is usually done within a period of 30 (thirty) days from the date of the application. However, given the current scenario and emergent situation, a shorter approval period of less than 7 (seven) days has been indicated by the regulator.
2. Step 2: Performance Evaluation of the Kit
Process: Rule 59 of the MD Rules provides that upon successful development of the testing kits, the same are required to be submitted for testing and clinical performance evaluation. Such performance evaluation is done for compliance with existing testing standards that are set by the ICMR in concordance with global practices. There is also a provision for expedited review in this regard. In terms of Rule 59(4) of the MD Rules, such requirements can be deferred/ waived of keeping in mind general public interest. To enable fast track validation of kits, the Indian Council of Medical Research (ICMR) has designated various institutions such the National Institute of Virology, Pune (NIV) to evaluate and validate such kits.
Timelines: Results of such clinical performance evaluation are being published within a period of less than a week. If the testing kits are found to be performing satisfactorily, the same are recommended for issuance of approval for manufacture and the developer can proceed to apply for a manufacturing licence for the same. However, if the evaluation finds issues with the performance of the kits, then the applicant has an option to re-submit the test kits for clinical performance evaluation, after making the necessary changes therein. The ICMR is regularly updating information as regards test kits that have been given clearance for approval.
3. Step 3: Manufacturing Licence/ Import Licence
Process: Upon receipt of satisfactory report from ICMR / NIV / any other duly authorised testing institutes, the developer is required to apply for a licence to import/ manufacture such COVID-19 test kits for the purposes of Import/ Manufacture for sale or distribution within India. This application would be required to be accompanied by a host of supporting documents and information. In terms of Rule 21(5), before granting a licence, an inspection of the manufacturing facility would also be carried out by the licensing authority. Thereafter, if everything is in order, a manufacturing licence or loan manufacturing licence (as the case maybe), is issued in Form MD-9 or Form MD-10, as the case maybe.
Timeline: In the usual course of business, the time taken for issuance of the licence can take up to 105 (one hundred and five) days from the date of submission of application by the applicant. However, this time frame has been reduced to cater to the current emergent situation.
Expedited Approval Protocol
On March 19, 2020, with a view to encourage development and manufacturing of COVID-19 test kits and expedite the lengthy approval process, the Central Drugs Standard Control Organisation (CDSCO) issued a public notice, clarifying the expedited regulatory approval mechanism it has put in place for such test kits.
Process: As per the aforesaid notice, applications submitted to the CDSCO for conducting performance evaluation and to import or manufacture in vitro diagnostic kits for sale or distribution will be processed on a high priority basis, wherein the concerned applicant can directly approach the CDSCO’s Public Relations Office for guidance on the expedited regulatory pathway. Further, this notice states that data requirement for clinical performance evaluation etc. may be deferred, abbreviated or waived off on a case to case basis, depending upon the nature and type of the diagnostic kit, existing data on the product and evidence of available clinical performance evaluation data of such kits. Applications for conducting performance evaluation and applications for import or manufacture of testing kits for sale or distribution are also required to be processed on a high priority basis through the expedited review and accelerated approval process.
Timelines: The applications to manufacture or import the in vitro diagnostic kits for the purposes of testing, evaluation, or further use in performance evaluation as per the aforesaid notice is required to be processed within 7 (seven) days.
In light of the challenges posed by the COVID-19 pandemic, the government and the regulatory bodies have risen up to the occasion with respect to prioritising approvals for essential items, and simplifying application, documentation and testing requirements. Review of test kits is being done on an expedited basis, with reports of some reviews having been completed in less than 36 hours. Processes such as site inspections, which used to be tedious, are being completed within a period of 1 (one) day in many cases, with approvals being granted within 24 hours of a positive evaluation report. This is a welcome change in the review and approval time frame which, if continued and further streamlined, will aid in ensuring that India meets the demand for test kits that has risen as a result of the current pandemic. If nothing else, such positive steps are proof enough that our regulatory agencies can meet any challenge that is thrown at them and one can hope that this becomes a regular way of working, a new normal so to say!
 In terms of Rule 3(zb) of the MD Rules, ‘medical devices’ have been defined to include inter alia substances used for in vitro diagnosis.
 In terms of the Fourth Schedule of the MD Rules, the documents required to be submitted along with application to manufacture a Class C medical device (we understand that the Central Licensing Authority is classifying COVID-19 test kits under ‘Class C’) include inter alia the site/ plant master file, details of the manufacturer, the device master file, Essential Principles checklist for demonstrating conformity to the Essential Principles of Safety and Performance of the device, and a copy of performance evaluation report of the device.