Why the National Dope Testing Laboratory (New Delhi) has been suspended by WADA and what it means for Indian sport
One important prong in the fight against doping that has been pioneered by the World Anti-Doping Agency (WADA) is the collection of athletes’ samples, the chain of custody and the accurate testing of the samples. For this to work, laboratories across the world must adhere to strict international standards that are designed to ensure that the testing process is undertaken with utmost care. Alongside the prohibited list, this forms a crucial aspect in the fight for clean sport to ensure that every participant on a level playing field.
Thus, the news of the National Dope Testing Laboratory (NDTL) in New Delhi, India being suspended for a period of six months, starting August 2019, due to non-conformities with the International Standard for Laboratories was disappointing to proponents of clean and fair sports.
This article provides an explanation of events and its potential impact on Indian sport. Specifically, it examines:
The process of accreditation for a laboratory to be qualified to test samples of athletes (including the grounds for maintaining accreditation and for its suspension and revocation).
The grounds on which the NDTL’s accreditation was suspended.
Instances of suspension of other laboratories; the steps that may be implemented by a laboratory to have the suspension revoked; and the consequences of continued non-compliance leading to permanent revocation of accreditation.
The potential impact of the NDTL’s suspension on the anti-doping regime in India.
WADA Code and the International Standard for Laboratories
The World Anti-Doping Code1 (WADA Code) works in conjunction with six international standards2, which aim to foster consistency among anti-doping organizations in various technical areas, including the International Standard for Laboratories (ISL), to ensure production of valid test results and evidentiary data to achieve uniform and harmonized results and reporting from all accredited laboratories3. These international standards have been devised after lengthy consultation among all WADA stakeholders4 and are mandatory for all signatories5 of the WADA Code.
The ISL was published on June 2, 2016. The ISL and its related technical documents (Technical Document(s)) specify the criteria that must be met for accreditation, maintenance of accreditation and re-accreditation, as well as standards that must be met for the production of valid test results and evidentiary data. WADA publishes, from time to time, specific technical requirements, addressing particular operational areas of the accredited laboratories, in the Technical Documents. The list of Technical Documents in force currently and their modifications are available on the WADA website.6
The Technical Documents constitute the second level elements in the entire regime of the World Anti-Doping Program after the international standards and therefore the implementation of the technical recommendations described in them are mandatory and are applicable in accordance with the effective date specified in the Technical Document. Technical Documents supersede any previous publications on a similar topic, or if applicable, the ISL. The Technical Document brought into force most recently preceding that of the sample receipt date by the laboratory shall be the one applicable to the particular incident.
In cooperation with WADA, the International Anti-Doping Agreement (IADA) has also developed guidelines for Anti-Doping Organizations that have already obtained an International Organization for Standardization (ISO) certification or that wish to be ISO-certified. The International Laboratory Accreditation Cooperation (ILAC) conducts the assessment concurrently with the ISO/IEC 170257 assessment for testing and calibration laboratories, for the WADA accredited anti-doping laboratories.
The first step in the accreditation process is the application and the preparation by the laboratory applying for accreditation, before the receipt of the accreditation. Once accreditation has been obtained, the laboratories are required to take certain steps in order to be in compliance of the ISL and to maintain the accreditation. The procedure for each of these steps is set out in the ISL.
WADA provides for a lengthy accreditation process. WADA requires for laboratories to be in compliance with the ISL and it monitors the performance of the laboratories through a mandatory External Quality Assessment Scheme (EQAS). EQAS allows evaluation of laboratory competency through a continuous assessment of their performance and provides laboratories with opportunities to compare their results, with the aim to enhance harmonization of test results among accredited laboratories. EQAS also incorporates educational opportunities for the WADA accredited laboratories.8
The accreditation is only received by a laboratory after going through a plethora of steps such as first filing an expression of interest9, being compliant with the WADA Code and the ISL, having the support and endorsement from the national anti-doping agency in the respective country, the laboratory providing all requisite documentation, being in compliance of the ISO/IEC 17025, conducting simulate sample tests, on site audits, etc. in compliance with the Section 4.2 and Section 4.3 of the ISL.
Maintenance of Accreditation
The accreditation once received, can only be maintained if the laboratory remains in compliance with the requirements stated in Section 4.4 of the ISL, including but not limited to ISO/IEC 17025 Accreditation10, participation in the WADA External Quality Assessment Scheme11, laboratory independence12, minimum number of samples analysed13 etc.
In order to ensure that laboratories continue to adhere to the standards set out in the ISL, WADA has the right to inspect and reassess an accredited laboratory at any time. Usually this inspection is conducted with a notice given in writing, but exceptionally the inspection may also be conducted unannounced.14 As part of this assessment WADA can request documentation held by the laboratory or re-analysis of various samples and can also request re-assessment related to ISO accreditation.15
Suspension and Revocation of Accreditation
The accreditation of a laboratory can only be suspended or revoked if WADA has substantiated and justified reason to believe that such suspension or revocation is necessary to protect the interests of all stakeholders and integrity of sports at large.16 The decision to revoke the accreditation or suspend is taken on a case to case basis, after giving due consideration to several instances of failure, including but not limited to, evidence of non-compliance with the requirements of the ISL, loss of ISO/IEC 17025 accreditation and failure to take appropriate corrective action following unsatisfactory EQAS performance.17
Any suspension of accreditation may be based on several reasons, such as the results of the EQAS or other evidence of serious ISL deviation(s) arising from the routine analysis of the samples. The suspension of the accreditation is proportionate to seriousness of that non-compliance keeping in mind the need to ensure accurate and reliable drug testing of athletes. The period of suspension may imposed for a maximum of six months, initially, with the option to extend the suspension for a further six months in the event the non-compliance is not remedied.18 If the non-compliance(s) cannot be corrected during the initial suspension period, the suspension may either be further extended or the laboratory accreditation may be revoked. In the event the laboratory provides evidence (at the end of a maximum of 12 months) that is deemed to be satisfactory evidence by WADA of correction of non-compliance, the laboratory’s accreditation may be re-instated else the laboratory’s accreditation maybe revoked.19
A laboratory whose accreditation has been suspended becomes ineligible to perform testing of doping control samples, except when the non-compliance(s) is restricted to analysis for the class of compounds or analytical method in which the non-compliance(s) occurred. During the suspension of the laboratory, WADA may require the laboratory to successfully analyse blind EQAS samples and/or require an on-site assessment by WADA, at the expense of the laboratory, in order to evaluate the laboratory’s status.20
Revocation of accreditation, on the other hand, is reserved for more serious instances of non-compliance, for example repeated suspensions, repeated failure to take appropriate corrective measures following unsatisfactory performance either in routine analytical testing or in blind EQAS round(s), failure to correct a lack of compliance during the suspension period, non-compliance with WADA EQAS, failure to cooperate with the WADA or the relevant testing authority during the suspension phase, failure to inform clients of the suspension of accreditation, etc.21
WADA is required to gather all documentation required to investigate issues that might give rise to suspension or revocation of accreditation, review it and produce a written report to the WADA Disciplinary Committee who, in turn recommend suspension or revocation to the chair of the WADA Executive Committee.22 A laboratory whose accreditation has been revoked is ineligible to perform testing of doping control samples for signatories. The chain of custody maintained by a suspended or a revoked laboratory for stored samples is valid until such time that arrangements can be made, in consultation with WADA, for the transfer of relevant samples to other laboratories as soon as practical.23
WADA may lift the suspension only once sufficient evidence, as determined by WADA, is provided by the laboratory that appropriate steps have been taken to remedy the issue(s).24 WADA’s decision to suspend or revoke a laboratory’s accreditation may be appealed by the laboratory to Court of Arbitration for Sport (CAS) within 21 (twenty-one) days from the decision notification.25 Arguments of ignorance of the requirements of the ISL or that any failures led to no actual harm are unlikely to be accepted as valid grounds for allowing such appeal.26
Suspension Of Accreditation Of National Dope Testing Laboratory, New Delhi
The NDTL was established in 1990 and was revamped in 2002 with the aim of getting accreditation. The NDTL got the ISO/IEC 17025 accreditation in 2003 and hence applied for WADA accreditation in the same year. After signing the Copenhagen Declaration on Anti-Doping in Sport in 2004, NADA was registered with the WADA in 2007. The NDTL then gained the accreditation in 2008. The NDTL is an independent body, responsible for analytical testing of samples and research in the field of dope analysis.
It may be noted that the WADA had been giving repeated warnings to the NDTL to bring its testing methods in line with ISL and the related Technical Documents. Previously, there have been various instances of Adverse Analytical Findings returning as ‘positive’ from other WADA accredited laboratories after the same samples were declared as ‘negative’ by the NDTL.27
In 2016, the initial negative report for a youth Olympics silver medallist was overturned by the Cologne laboratory on conducting an IRMS analysis28.
In 2017, WADA inspection team had reportedly collected approximately 100 samples and transported them to the Montreal laboratory for retesting and it was found that six of them, which were declared ‘negative’ by the NDTL actually gave ‘positive’ results. It was presumed at the time that the positive results could be due to the higher prowess of the Montreal laboratory, however this is the very reason that ISL exist i.e. all laboratories are expected to have the same technology and mechanisms to ensure equal footing of the players, throughout the world.
In the case of Inderjit Singh, there were claims of lapses in the sample collection and storage process. The Anti-Doping Appeal Panel of India had recorded after detailed hearings that there were deviations in the testing standards followed by NDTL in that case. But after an appeal to CAS, it was clarified that there was no deviation by NDTL in the sample testing and the athlete was granted a suspension for commission of an anti-doping rule violation.
A similar confusion arose in the case of Davinder Singh Kang wherein his positive result was withdrawn by the NDTL without any explanation in November 2017. This case was not taken up by the Athletics Integrity Unit but was being reviewed by the LabEG. Following this, WADA launched its disciplinary proceedings in May 2018.
In September 2018, WADA, through its team had made a site-inspection visit to the NDTL in accordance with Section 22.214.171.124 of ISL29. During the inspection, there were four major objections made regarding:
Isotope Ratio Mass Spectrometry (IRMS) sampling procedure;
Validation of the IRMS data for samples collected over the last 10 (ten) years;
Faulty standard operating procedure (SOP) of the laboratory with regards to the testing of samples;
Inefficient quality management team.
In April 2019, after monitoring the progress over the months, however noticing that no headways were made, WADA served the NDTL with a suspension notice. Subsequently there was an exchange of email correspondences and meetings between the Ministry of Youth Affairs and Sports ( MYAS ) and the WADA president, Sir Craig Reedie, but the exercise did not yield any positive results.
In May 2019, disciplinary proceedings were initiated by WADA’s Laboratory Expert Group ( LabEG ) and subsequently carried out by an independent Disciplinary Committee appointed by WADA, which was mandated to make a recommendation to the chairman of the WADA Executive Committee regarding the suspension of the NDTL’s accreditation.30
WADA, on August 20, 2019, suspended the accreditation of the NDTL for a period of upto six months31. WADA through a press release32 stated that the suspension had been imposed due to non-conformities with the ISL as identified during the WADA site visit, including in relation to the laboratory’s isotope ratio mass spectrometry (GC/C/IRMS) analytical method, as regulated by the relevant Technical Document number TD 2016 IRMS.33
As a consequence of the suspension, the NDTL is prohibited from carrying out any anti-doping activities , including the analysis of urine and blood samples. During the period of suspension, the samples that have not yet been analysed by the NDTL i.e. samples currently undergoing a confirmation procedure and/or any samples for which an AAF has been reported, are required to be securely transported to other WADA-accredited laboratory(ies).34
Pursuant to Section 13.7 of the WADA Code35 and Section 126.96.36.199 of ISL, as discussed earlier, the NDTL could have appealed this decision of suspension to CAS within 21 (twenty-one) days of receipt of notice, but the MYAS chose to not file an appeal.
When the news of the suspension of the NDTL broke in the popular media, the newly appointed sports minister of India noted that appropriate corrective measures were being taken in relation to the issues in the functioning of the NDTL and said that the MYAS aimed to take corrective measures within two months.36 Regardless, the NDTL has time till February 2020 to make itself compliant with the ISL and the related Technical Documents.
Instances of Suspensions Of Other Laboratories
WADA has suspended various laboratories as a part of the rigorous implementation of the ISL, post which, subsequent compliance and conformation from such laboratories have also led to their reinstatement. For instance, the laboratory at Doha was suspended for a period of four months (the decision of the chairman of the WADA Executive Committee can be found here) and was reinstated five months after the suspension. 37 The Beijing laboratory was suspended for a period of four months38 but was reinstated within the suspension period after complying with ISL requirements. 39
The Bucharest laboratory40 and the Paris laboratory41 were suspended and were reinstated based on recommendations made by LabEG, after being satisfied that the laboratories had successfully addressed their non-conformities.42 Similarly, the accreditation of the Rio laboratory was reinstated just in time for the Rio Olympics.43
In the instances where the suspended laboratories were unable to make amends post their suspension and extension periods thereof, the accreditation of such laboratories was revoked. For instance the Moscow laboratory’s accreditation was suspended for a period of six months on November 10, 2015 (the decision in relation to the suspension can be found here) and revoked thereafter in April 2016.44 Similarly, the Bloemfontein laboratory was given a suspension45, and thereafter its accreditation was revoked on June 30, 2017 and was the case with the Almaty laboratory. 46 Another instance wherein a one-year suspension was invoked was of the Lisbon laboratory47, wherein WADA noted that the irregularities persisted thereafter and therefore instituted disciplinary proceedings against it .48
The fight for clean sport is an ongoing process and in the entire scheme, there is no doubt that along with enlisting the prohibited substances, setting the measures and standards for maintaining the anti-doping regime is equally significant. The aspect of collection of samples by the doping control officers and the testing of the collected samples in accordance with internationally recognised standards must be followed. As mentioned earlier, WADA conducts random checks on the laboratories in relation to the adherence to international standards, from time to time. These checks are vital for the maintenance of not just uniformity and efficiency, but also the independence and impartiality of the laboratories. It is these routine tests that led to the finding that the NDTL was not in compliance of the ISL and was thereby suspended.
Earlier this year, the Board for Control of Cricket in India (BCCI) had raised issues in relation to the independence, capabilities and competence of the NDTL49 and had been using the Swedish International Doping Tests and Management (IDTM) for testing of samples. An example of failure of NDTL returning timely tests results was the case of Prithvi Shaw (cricketer), wherein the player was allowed to play in the Indian Premier League (IPL) because the reports were sent after a two-month delay, by which time the IPL 2019 season had concluded.50 NDTL must bear these things in mind while making amends.
By February 2020, the NDTL is required to address all non-conformities identified by the LabEG / WADA, as well as any additional non-conformities identified during any follow up WADA site visit during the suspension period. Should the laboratory not address the non-conformities by the end of the six-month suspension period, WADA may extend the suspension of the laboratory’s accreditation for up to an additional six months and further non-conformity may lead to revocation of the accreditation altogether. If the laboratory satisfies the LabEG in meeting these requirements prior to the end of the suspension period, it may apply for revocation of the suspension.
While the NDTL remains suspended, such suspension does not prevent NADA from collecting samples, however the samples must be sent to other WADA accredited laboratories. This poses a major setback for India’s anti-doping programme. The costs of transporting the samples and actual testing shall go up manifolds during the suspension period.51 Concerns have been raised by the president of the Indian Olympic Association (IOA) in relation to the increased costs and that the burden to bear the same will be unfairly on the IOA. This further creates a hurdle in the current situation, which may eventually lead to lesser tests being done and lesser vigilance over the athletes.52
The direct implication was seen in the recently held inter-state athletics championships, wherein, as a consequence of the suspension of the NDTL, there was ambiguity over the monitoring of the event.53 While the officials of the Athletics Federation of India (AFI) assured that a five-member team comprising of NADA officials would be present at the venue for sample collection, concerns over the cost of getting the samples attested by foreign laboratories were raised. Even more problematic was the suggestion given by the officials that they would “ try to cover all major events ” and that the “ number of samples collected may be lesser than usual because we will have to arrange their safekeeping and process sending them to another Asian lab for testing ”.54
The suspension of NDTL has led to NADA losing the freedom of testing athletes whenever necessary as it is first required to find out in which laboratory does an availability to conduct tests exists, especially the time sensitive ones like in-competition, where expedited results are of essence. This will further lead to degradation of the whole scenario if lesser number of samples collection could create the illusion in the minds of the athletes that it is a free pass to dope. The logistical and situational problem aside, with the Tokyo Olympics, 2020 approaching close, the NDTL suspension might lead to increased number of AAFs and thereby hindering participation. Therefore, it is imperative that the NDTL gets the suspension revoked by complying with the ISL and in a timely manner.
The suspension shows a mirror to the Indian anti-doping regime and brings into light important issues of the inadequacy of allocation of resources and qualified manpower to NADA and NDTL. India being an aspiring sporting power, it is critical to professionalise its anti-doping framework to a standard, which stands any tests of international scrutiny. Given the fact that the legal framework of anti-doping is based on the strict liability of the athlete, it is imperative to have reciprocal obligations of the authorities with stringent duty placed on them in the process and mechanism of anti-doping management. The suspension of the NDTL can be taken as an important trigger for bringing about a comprehensive overhaul via debate, assessment and revamping of the entire system, not just the NDTL.
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- Tags: Anti-Doping | Athletics | Athletics Federation of India (AFI) | Board for Control of Cricket in India (BCCI) | Cricket | Governance | India | International Anti-Doping Agreement (IADA) | International Standard for Laboratories (ISL) | National Doping Test Laboratory (NDTL) | Regulation | The Indian Olympic Association (IOA) | WADA Code | World Anti-Doping Agency (WADA)
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Counsel, AM Sports Law and Management Co.
Ms. Aastha Kothari is a counsel at AM Sports Law and Management Co. since May, 2018. She did her schooling from St. Xavier’s School, Jaipur and secured her bachelor’s degree in law from the West Bengal National University of Juridical Sciences, Kolkata in 2018.
During her years at law school, she did her internships at the Law Offices of Nandan Kamath, Bangalore, Star India Pvt. Ltd., Mumbai, AZB & Partners, Mumbai and Surana & Surana International Attorneys, Chennai, thereby gaining experience in various fields like Sports Law, Media and Entertainment Laws and Policy, Intellectual Property Laws and Corporate Laws.
Her core areas of interest are Sports Law, Media and Entertainment Laws and Intellectual Property Laws. She has so far been involved in assisting in the setting up of various leagues. She regularly engages in transactional work and advises clients on various rules and regulations for conducting the leagues. Being a national level football player herself, Aastha has seen the difficulties faced by female athletes in a less popular sport in India. She wishes to make a difference by her contributions in the legal field and bringing in awareness and education about anti-doping in the lesser-privileged sections.
Founder, AM Sports Law & Management Co
Ms. Aahna Mehrotra is the principal lawyer at AM Sports Law and Management Co. She was called to the Bar in May 2011 and has gained considerable exposure through her experiences at different institutions worldwide.