Bio contamination from labs is a serious concern that can have social, economic, political and environmental implications. Sometimes, irreversible ecological contamination is a given consequence. Health Canada reports that world-wide until 1999 over 5,000 cases of accidental laboratory infections and 190 deaths[1] have been recorded. These reports are the tip of the iceberg and point to the clear dangers and risk of virus research, even within rigorous biosafety protocols. The critical question then is this:
- In the current COVID 19 pandemic, what is the potential for escape into our Indian environment of this SARS CoV 2 virus due to the unsafe handling of an estimated 230 million specimens/ samples (as of 10th May, 2021) collected for testing, as well as the inadequate biosecurity in our labs? Is it reasonable to ask whether the current second wave and a rising mortality, could in part be due to the perilous consequence of a dangerous disintegration in rigorous biosafety protocols? This article addresses these matters.
A biosafety level (BSL), or pathogen/protection level, is a set of biocontainment precautions required to isolate dangerous biological agents in an enclosed laboratory facility. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4).
Experts opine that more accidents in research labs happen due to inadequate adherence to prescribed guidelines regarding the handling of hazardous agents, viz (i) poor understanding of prescribed laboratory procedures, (ii) poor training of laboratory personnel, (iii) handling and transfer of inadequately inactivated preparations of dangerous pathogens to areas with reduced bio security levels; and (iv) disposal of infected materials without proper disinfection[2].
In India, within the human healthcare sector, there are more than 800 medical and healthcare research facilities, about 575 medical colleges, 350 universities, 18,000 pharmaceutical and biotech industrial units and numerous hospitals and diagnostics laboratories. All these labs handle viruses, bacteria and biomedical waste. It is estimated that among them a mere 30 laboratories are at BSL3 or BSL2+ levels, mostly with public institutions such as CSIR, ICMR and DRDO, vaccine manufacturers and other research institutes. And, only 3 BSL4 lab facilities in public institutions are functional in India. The first BSL4 lab in India was inaugurated in 2013 at National Institute of Virology, Pune[3]. However, there is no comprehensive, authoritative list of existing laboratory resources in India.
Biosafety Audits – Indian Regulatory mechanisms
India does not have a legislation dedicated to biosafety. With the growth in development of basic and applied research in microbiology and biotechnology, India LACKS legislation to define and enforce the relevant biosafety protocols in handling pathogenic material in laboratory conditions. Many countries have sanitary regulations and standards, which have significantly been modified and improved over years of experience.
In 2016, National Centre for Disease Control, under Ministry of Health, developed a Biosafety Manual for Public Health Laboratories[4]. Interestingly, this Manual refers to Bio-medical Waste Management Rules, 2016, formulated under Environment Protection Act, 1986. Virology scientists[5] conclude that there are no national agencies in India to audit and validate BSL-3 laboratories.
Incidentally, after more than a year of COVID 2019, India is yet to update its Gazette Notification No. G.S.R. 613(E) dated 16th July, 2010[6], wherein the Risk Groups have notified hazardous micro-organisms, under Risk I, II and III. SARS-COV-2 is not yet included in the Risk List of India. This notification, the latest available, includes the Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms/Genetically Engineered Organisms or Cells Rules 1989, to be administered by Genetic Engineering Appraisal Committee, under Union Ministry of Environment and Forests, Government of India. Currently, Institutional Biosafety Committees (IBSCs) are mandated to do this. There are some 300 IBSCs for related labs in industries and research institutions. No information is available on the work and procedures of these IBSCs in enforcing virus containment procedures.
In 2006, the Mashelkar Committee on R-Pharma recommended establishment of an independent inspection facility to audit the manufacturing and containment facilities set up by the companies involved in vaccine manufacturing. This has not been done.
Risk of virus release from Labs
Lab Specimens: With the lockdown, in March 2020 due to the COVID 19 pandemic, the requirement to conduct diagnostic testing by RT- PCR and Rapid Antigen tests increased exponentially and required concomitant laboratory capacity to cater to the sheer nos. that would be required. The real possibility of a COVID 19 spread from labs therefore, needed to focus on these ‘numero uno’ diagnostic centres to ascertain the risk. Several lakhs of swabs are generated every day, with possible contamination of the COVID 19 virus. Disposal of these swabs are governed by Biomedical Waste Management Rules, framed under Environmental Protection Act, 1986, by the Central Pollution Control Board[7]. COVID 19 related medical waste disposal is as callous as it can be[8]. The huge attendant magnitude of generated Lab waste includes masks, gloves, PPE kits, empty syringes, vials, bottles, contaminated swabs and samples of urine and blood and other bio-samples[9]. In addition, it is not unreasonable to question whether improper disposal of liquid and solid wastes into city sewers is a possible, or even probable source of COVID 19 contamination.
Vaccine Manufacture: this of course, is THE ISSUE that confronts us urgently, with regard to risk and contamination. Vaccine research and manufacturing facilities are serious potential sources. Some kinds of vaccine production[10] involve inactivation of whole viruses or bacteria with chemicals, heat or radiation. These inactivated viruses or bacteria are then reproduced in large quantities and prepared for use as a vaccine. Inactivation of viruses has to be 100 percent effective. In the past, inadequate quality-control led to deaths and disability. In 1955, California-based Cutter Laboratories failed to fully inactivate the vaccine, leading to one of the worst manmade polio outbreaks in history, causing abortive polio in about 40,000 children, paralysis of 164 people and ten deaths.
In India, Bharath Biotech received Emergency Use Authorisation (EUA) of its vaccine even before Phase 3 trials. This shortening of approval protocols was ‘justified’ due to the official perception of risk. Due to this, the product itself has created hesitation over safety concerns. Not many are aware that the process was also marked unsafe by Brazil, not India. In April, 2021, Bharath Biotech was denied a certificate by Brazilian Health Regulator ANVISA (the Portuguese Agência Nacional de Vigilância Sanitári), after inspecting the unit, as part of the process to procure COVID-19 vaccine, Covaxin[11]. It questioned the adequacy and effectiveness of methods used for “sterilising, disinfecting, removing or inactivating viruses”. ANVISA nailed the serious aberrations that pose a significant risk to manufacture and quality assurance of this vaccine, implying a health risk to users on par with the COVID 19 pandemic.
In 2017, the WHO carried out a Public Inspection Report[12] of Bharath Biotech facilities in Hyderabad. This report concludes “acceptable level of compliance with WHO Good Manufacturing Practices”; but, it also points to a number of deficiencies, including problems in third party maintenance, temperature excursions into secure areas, product recalls due to missing ingredients and lack of containment facilities normally used for operations handling live viral agents.
Based on the ANVISA report, Priyanka Pulla, a science writer, raises serious questions about biosafety at Bharath Biotech and lack of oversight by Central Drugs Standard Control Organisation (CDSCO)[13]. On January 21, 2021, a fire broke out at Serum Institute in Pune killing 5 people. No detailed reports are available on this accident. UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reportedly done an audit of SII facilities in February, 2021[14]. This report is not available for public review.
The Government of India is providing financial grants for enhancing production capacities in 3 vaccine manufacturing facilities[15]. Inter-ministerial teams visited 2 main vaccine manufacturers to make an assessment. Vaccine manufacturing is set to rise, leading to an increase in the number of virus-centric laboratories to meet the demand. Data is absolutely required to be in the public domain. It is not.
Conclusion
It is clear that there are major gaps in biosafety, across all dimensions of the problem as described. It is also clear therefore, that India needs rigorously defined and rigorously enforced biosafety regulatory protocols on a war footing. The lacuna highlighted by the Brazilian regulator in the Bharath Biotech vaccine production facility indicate just how precariously we are placed. But, and on the other hand, and particularly in the light of this, it invites utter scepticism that India continues to rely on the utterly SPARSE safety assurance of SELF-CERTIFCATION.
It is quite astonishing that the Indian government itself, has not carried out the obligatory and critical work of biosafety audits to provide the necessary quality assurance in Indian vaccine manufacturing facilities. It justifies similar questions being asked about biosafety rigour and quality assurance in the collection and transfer of sampling specimens and RT- PCR labs involved in the testing/diagnosis of COVID 19.
I therefore, return to my Q at the start. We have an unprecedented rise in RT-PCR- generated COVID 19 diagnoses. We also have visible (all around us) rising fatalities. Our already tottering and ignominious health services before the pandemic, have now fallen off the cliff – a complete collapse, indicating that clearly, the deaths may not be assigned exclusively to COVID 19 by any means. But, the question remains:
- What is the reason for the heightened presence of the virus? Here-in lies the possibility of the increase in infections due to virus escape, attributed directly to a significant lack of rigour in both the formulation of protocols of biosafety and their implementation. We are in an unprecedented emergency arising from these glaring biosafety gaps that need to be rectified urgently.
And finally, I also ask—where are our EPIDEMIOLOGISTS who can untangle the scientific conundrum of COVID 19, if not the moral conundrum?
Dr. Narasimha Reddy Donthi has been a passionate campaigner on environmental and development issues. He has contributed to public discourse and policy changes in electricity, seed, rice, cotton, sugarcane, sericulture, handloom and textiles, land, water and other related areas. He built campaigns, advocacy programmes and policy change projects. He is an author, writing on different subjects in regional, national and international publications. He also guides students in their Ph.D and other research activities.
[1] Health Canada and https://www.ryerson.ca/content/dam/facilities-management-development/environmental-health-safety/docs/2-biological-hazard-classification.pdf
[2] https://www.idsa.in/cbwmagazine/RecentIncidencesofGlobalBiosafety_bmgandhi
[3] https://globalbiodefense.com/2013/03/11/india-completes-first-biodefense-level-4-lab/
[4] https://ncdc.gov.in/WriteReadData/l892s/File608.pdf
[5] Mourya DT, Yadav PD, Majumdar TD, Chauhan DS, Katoch VM. Establishment of Biosafety Level-3 (BSL-3) laboratory: Important criteria to consider while designing, constructing, commissioning & operating the facility in Indian setting. Indian J Med Res 2014;140:171-83
[6] http://moef.gov.in/en/project-approvals/geac-clearances/notification/
[7] Datta, Priya et al. “Biomedical waste management in India: Critical appraisal.” Journal of laboratory physicians vol. 10,1 (2018): 6-14. doi:10.4103/JLP.JLP_89_17
[8] https://www.downtoearth.org.in/blog/health/biomedical-waste-management-in-india-still-a-looming-concern-63896
[9] https://swachhindia.ndtv.com/india-generated-over-18000-tonnes-of-covid-19-related-bio-medical-waste-in-4-months-experts-call-to-reduce-reuse-and-segregate-52901/
[10] https://www.bharatbiotech.com/blog/the-emergence-of-inactivated-vaccines/
[11] https://science.thewire.in/health/brazil-bharat-biotech-covaxin-anvisa-manufacturing-standards-certificate/
[12] https://www.who.int/immunization_standards/vaccine_quality/WHOPIR_Bharat27Feb-03March2017.pdf
[13] https://www.thequint.com/coronavirus/explained-why-is-cdsco-silent-on-brazils-report-on-bharat-biotech-plant#read-more
[14] https://www.reuters.com/article/health-coronavirus-india-britain-exclusi/exclusive-uk-auditing-indian-vaccine-site-amid-scramble-for-shots-sources-idUSKBN2AF1CG?rpc=401&
[15] https://pib.gov.in/PressReleseDetailm.aspx?PRID=1712271
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