What Does It Take to Get a COVID-19 Test Kit Approved in India?

What Does It Take to Get a COVID-19 Test Kit Approved in India?

While the ICMR has welcomed private companies to sell their diagnostic kits in the country, the process for getting the approval involves multiple steps.  

(Photo: iStock)

As India continues to see a steady rise in its COVID-19 cases, constant efforts are being made to ramp up testing and formulate strategies to prevent the disease from spreading in the country.

As part of these efforts, the Indian Council of Medical Research has approved private manufacturers to supply test kits to ICMR-approved government as well as private labs to conduct tests for COVID-19, the disease caused by the novel coronavirus.

According to its guidelines dated 28 March, RT-PCR probes for COVID-19 testing are currently procured from the US and distributed to the testing laboratories across the country by the National Institute of Virology (NIV).

With the latest order, private companies whose kits have been approved by the drug regulatory bodies in the US (FDA) or the European Union (CE), can sell the kits in India directly after getting an approval from Drug Control General of India and an ICMR intimation. Kits without such international approval, however, will have to go through evaluations by a designated centre in India.

In order to validate these non-FDA/CE approved kits from private manufacturers, the ICMR has identified four national institutes (including NIV) to conduct evaluations. Kits from 17 companies have been tested by NIV so far, with only four out of these getting the ICMR recommendation for attaining manufacturing licenses.

FIT tried to reach out to all these companies to understand the approval process, the criteria they need to meet to qualify for licensing, and the challenges they face or continue to face in order to get the validation. Regardless of their approval status (rejected or pending), getting responses from most of the manufacturers proved to be tricky and challenging.

We managed to speak to representatives from the Pune-based ‘Mylab’, the first Indian company to get its PCR kit approved by Central Drugs Standard Control Organization (CDSCO), ‘Trivitron’, a Chennai-based company that is set to send its test for approval next week, and Altona Diagnostics, a German-based company which has gotten the approval. Two other companies refused to comment before knowing their evaluation results.

The Criteria for Getting Approvals

Manufacturers need to pass through various stages before they can start selling their kits. The procedure involves a company to first conduct in-house research, get a ‘testing’ license from CDSCO and then send the kit to any of the four evaluation centres for quality and efficiency assessment. The centre (such as NIV) sends its recommendation to CDSCO, which finally grants the manufacturing license. The process, thus, involves the procurement of two kinds of licenses, first for testing, and then for manufacturing.

The ICMR has set a clear criterion for evaluating test kits that haven’t been approved by the US’ or Europe’s regulatory bodies. Only kits with “100% concordance among true positive and true negative samples have been recommended for commercial use in India”, and the four companies that have qualified for CDSCO license are Germany’s Altona Diagnostics, India’s MyLab and South Korea’s Seegene and SD Biosensor.

The four approved kits have been marked in red.

Speaking to FIT, Saurabh Gupta, spokesperson for MyLab, explained that 100% concordance translates into 100% sensitivity and specificity; meaning a test needs to be fully accurate in marking a diseased person as diseased and a non-diseased as non-diseased.

According to a report in The Ken, manufacturers (including multinational companies) have questioned India’s insistence on complete concordance. An Indian spokesperson of a global diagnostics company is quoted in the report as saying, “No kit in the world shows 100% sensitivity or specificity. Even a textbook definition talks of anything between 96% and 98%.” The report also mentions that a lot of the imported kits that are approved by the aforementioned foreign regulators may have an unfair advantage, by getting direct approvals to sell in India without meeting the 100% concordance (because that is not a standard required by the FDA or the CE).

Responding to a query on how realistic the criterion is, Saurabh Gupta from MyLab initially said that it is ICMR’s policy and it wasn’t their place to comment on it. But he went on to add,

Saurabh Gupta“It is definitely realistic. Four manufacturers have been able to achieve it, so yes, it is possible.”

Dr GSK Velu, Chairman and Managing Director at Trivitron, chose not to answer the question and said, “ICMR decides its own criterion and I cannot comment on that.”

Preparedness: Stock, Pricing & Supply

Gupta tells FIT that MyLab got its result after about a week of sending its kits for approval. Since then, it has been getting orders from everywhere. Currently, the company has a production and supply capacity of 20,000 tests a day, wherein 100 samples can be tested in one kit.

Saurabh Gupta, MyLab“We have a stock for 7-8 days and are trying to get more supplies, so there isn’t a shortage right now. A lot of the materials we require are outside of Pune and need to be transported from other areas. With the lockdown in place, we are getting help from the government with travel and transport. We are also trying to ramp up production, but it takes some time because quality checks have to be done at every level.”

The MyLab tests are priced at 1/3rd or 1/4th of the ICMR prescribed price of Rs 4500, which can mean somewhere between Rs 1000 to Rs 1500.

For Trivitron, which will be sending its indigenous test kits to NIV for evaluation next week, the lockdown has been a challenge. The company is already selling imported kits (Europe’s CE approved) from its Chinese Joint Venture, but getting goods from China has been a task. “We have around 3000 of these (imported) tests in stock and plan to import 20,000 next week. We are selling these kits at around Rs 1000 to Rs 1200 per test in the market.”

Dr GSK Velu, Chairman and MD, Trivitron“Lockdown is a big challenge to get imports, to move people for validation work and for movement within India. Our 100% indigenous kit will go for NIV approval next week and we hope to sell that at Rs 500 to Rs 700 per test . We can manufacture 200,000 plus RT PCR kits per week and scale it up if required.”

In conversation with FIT, Tarun Jain, General Manager, Altona Diagnostics India said, “Even though we need to get our kits imported from Germany, the government and all other central authorities have been very helpful in helping us get the supplies ever since we got the approval. Our policy is to serve our customers, and we are primarily focusing on private labs because of their relatively higher capacity of conducting more number of tests a day.”

The exact method of evaluation is yet to be made public. According to the Ken report, the dearth of supplies has led certain companies to increase their prices. A fast-tracked system in approving private test kits, especially those which are 100% indigenous, could help bring the prices down by increasing market players and offering relatively cheaper options than imported kits. A speedier mechanism, however, cannot be at the expense of the quality of the kits; as examples from countries such as Spain and Turkey have shown that imported kits can turn out to be faulty. Indian regulators will have to be on their toes to test every batch and ensure quality and efficiency, without slowing the process.

Activists Ask for Transparency, Free Testing

Speaking to FIT, Malini Aisola, the co-convener of the All India Drug Action Network (AIDA), said there still is a severe lack of transparency from the government’s end and a lot of questions remain unanswered.

Malini Aisola“We hardly have any information on which companies are allowed to import, which companies have the marketing license and what price they are selling the kits at.” 

Except for the list of those 17 NIV-evaluated kits, no details about other companies have been made public.

In a letter addressed to ICMR, she wrote, “We understand that a number of testing kits for COVID-19 have been given approval for use in India by the CDSCO. The kits would include those that would be imported into India and those that are being manufactured domestically. We are writing with a request that the status of all kits (RT-PCT, serology, rapid antibody kits, etc.) that have approached CDSCO for approval be made available in public as well as regularly updated.”

In this regard, she asks for the following details to be provided at a minimum:

• The basis on which each test kits has been granted approval - such as prior US FDA/CE approval, other foreign regulatory authority approval, or passing ICMR validation
• If the requirement for performance evaluation data has been abbreviated, deferred or waived
• The list of the test licenses granted

Letter written to Dr. Balram BhargavaDirector General, ICMR.

FIT got access to another letter addressed to the Prime Minister of India, in which AIDAN, All India Peoples Science Network (AIPSN) and Jan Swasthya Abhiyan (JSA) requested, among other things, for the concerned government ministries and offices to:

• Provide for full disclosure of the prices at which test kits are being supplied by each manufacturer as well as the costs of testing in public and private laboratories
• Accelerate the evaluation of pending applications of RT-PCR test kits for COVID-19 and subsequent approval by CDSCO of kits passing validation, and provide appropriate support for scaling up production to reduce costs
• Ensure timely procurement and supply of test kits approved by CDSCO for supply to Government and approved private laboratories for testing take urgent steps to secure supplies and to promote local production of reagents, raw material of reagents, and other physical components used such as swabs which are used in testing

Excerpt from the statement.

A Scroll.in article raised similar issues when it reported that the Drug Control General of India had given import and manufacturing licenses to at least 18 diagnostic kits, but details of 14 of them were not available in the public domain (the remaining four being the ones approved by NIV and thus mentioned in the ICMR list). Even the private labs permitted to conduct COVID-19 tests seem to not have the list of manufacturers, because of which they continue to ask for supplies from MyLab or Altona.

While transparency is one significant cause for concern, the other, according to Malini, is the price of the tests. “The government needs to take over. Testing needs to be free in the private labs as well. The government can step in, procure commercial kits from the companies, give them to labs for free and put in place a reimbursement mechanism.”

Malini Aisola“The testing cap of Rs 4500 means that there is a massive discrepancy. Some people can afford the tests from these labs, while others simply cannot. A few kits just cost Rs 500, then why is the test priced so high? How did the government arrive at this cap?

“There is no clarity. But irrespective of whether an individual is tested in a public or a private lab, the government needs to bear the cost,” she says.