A deadly mix of medical negligence and pursuit of the profit motive has spelt countrywide disaster and shows no signs of abating as yet. There is a spine-chilling story about the raging swine flu that has caused more than 10,000 deaths in the country over the past six years.
While the failure to detect the flu in its incipient, early stages is the primary reason for the deaths — still more scandalous is the manner in which the medical establishment has gone in for importing highly exorbitant ABI kits for detection of the disease, which makes those at the receiving end shell out Rs 5,000 for testing positive and twice that amount for testing negative.
In contrast, the indigenous detection kits could have been put to use for just Rs 700 per sample test. According to available figures, 47,000 ABI kits were imported in 2009 alone, the year that saw the pandemic break out in all its fury.
Even as the Delhi High Court directed the Centre and the Delhi government to provide affordable kits for testing swine flu, the racket in providing for affordable treatment continues. Meanwhile, it is authoritatively learnt that certain government-recognised institutions such as the Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI), Lucknow, and the National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru, have averred that the indigenous kits are either as effective or more effective than the imported ones, and accomplish the job at a fraction of the cost incurred in using imported kits.
It may be noted that ABI (Applied Biosystems Incorporated) merged with Invitrogen in 2008, forming Life Technologies, which was taken over by ThermoFischer Scientific, a US-based firm, in 2014.
It is intriguing that two separate wings of the Union health ministry were busy passing the buck and virtually presided over a racket of astronomical proportions.
The sordid tale is told in medical circles about how an indigenous firm was thwarted in its attempt to procure a manufacturing licence when it approached the concerned government body. It was directed to get in touch with the Indian Council of Medical Research (ICMR). When Tehelka asked the ICMR why the necessary No Objection Certificate (NOC) was not provided to the indigenous firm, it was asserted that only the Drug Controller General of India (DCGI) had the necessary authority to issue such a clearance.
On his part, Dr Vishwa Mohan Katoch, who was the director-general of the ICMR in 2009, told Tehelka that there had been a huge error and the officials concerned would be duly punished. Katoch expressed disgust at the apathy shown by his staff, but then such an attitude is prevalent at all levels of officialdom. Katoch admitted that the American firm, which supplied the testing kits, had made a neat killing and also that the swine flu tests were too exorbitant for anybody’s good and helped the firm rake in millions. That apart, the US firm also received unintended free publicity, he added. TS Jawahar, senior deputy director-general (administration) at ICMR and also the chief vigilance officer, admitted there was “utter lack of coordination” within the ICMR under the former UPA regime.
Consider this. Each of the 47,000 imported kits can be used to test at least 100 samples. The government has to pay Rs 10,000 to ABI for each test. In other words, the government incurred an expenditure of Rs 4,700 crore. Moreover, a senior official at the National Centre for Disease Control (NCDC) told Tehelka, “Some kits can be used for 100 tests and the rest for 1,000 tests.” If we take the higher limit into account, the expenditure incurred runs into Rs 47,000 crore.
On the other hand, one test by the indigenous kit costs only Rs 700. This means the government would have spent only Rs 329 crore for the same number of tests. So, if the indigenous kits had been used instead of the imported ones, it would have saved the exchequer a whopping Rs 4,371 crore (or even Rs 46,671 crore).
In marked contrast to the ICMR’s claim of providing medicare to a maximum number of poor people at the optimum level, this is a glaring example where unwittingly hundreds of patients have died even as the US firm makes super-profits. Jawahar concurred with the view, saying: “Yes, in this case the profit motive overrode other considerations.”
There were contradictory responses from the ICMR to an RTI application filed by the Indian firm that had applied for a manufacturing licence. The ICMR in its response said that it had no information in this matter. This clearly shows that one or the other government department was trying to evade responsibility.
When queried, the two ICMR officials, Dr Katoch and Jawahar, admitted to the blunder. Utter apathy and disregard has become so patent that Dr Arvind Rai, joint director of the division of biochemistry and biotechnology at the NCDC and member-secretary of the centre’s bio-safety committee, not only admitted that he was among those who favoured imported kits, but was also simply oblivious to the gaping cost differential between the imported and the indigenous kits. He also said, “If someone said that the cost of positive and negative results ought to be same, there was no logic in that.”
The flip side of the multi-million loot became manifest as investigations carried out by Tehelka revealed that several hundred lives could have been saved had the health department acted swiftly on the claim of the Indian firm Genome Diagnostics Pvt Ltd. The firm had come up with a kit, which they said was useful in detecting the swine flu virus at a preliminary stage. The firm contacted the health ministry to get the necessary approval and authentication, but to no avail.
After swine flu was declared a pandemic in May 2009, several research projects were carried out across the globe on various aspects of the disease, including its detection, prevention and treatment. It was during this period that the ICMR announced that India was importing detection kits from a US-
Soon after, when Genome contacted the DCGI, it was asked to first get its product validated from the ICMR. The ICMR had earlier asked the firm to get the necessary validation from three centres. That same month, the firm wrote a letter to Dr Surinder Singh of the DCGI and the health ministry. Even former prime minister Manmohan Singh’s intervention was sought, but to no avail.
AT A GLANCE
• Approximately 10,000 persons died in the last six years following late detection of the swine flu virus
• Expensive kits were imported from a US-based company, while the indigenous kits were available at a much cheaper rate and also had better capability
• While positive and negative tests done by ABI kit costed Rs 5,000 and Rs 10,000 respectively, the indigenous kit was available at Rs 700 per test
• In 2009 alone, 47,000 kits were imported; the exchequer could have saved Rs 4,371 crore by using the indigenous kits
• SGPGI, Lucknow, stated the indigenous kit was better than the imported one, while NIMHANS, Bengaluru, stated that it was just as good
• When the indigenous firm approached the DCGI for a NOC, DCGI asked it to go to ICMR, while ICMR told Tehelka that only DCGI was authorised to give NOC
• ICMR DG said, “It made me very sad. It is a big blunder due to which ABI made a lot of money. The guilty will be punished”
• ICMR replied to an RTI application from Genome that they don’t have information about the firm having approached it for a licence
• A member of the expert committee for swine flu said, “When the kits were being bought, I suggested that Rs 4,000 to Rs 5,000 per test was enough”
With no response forthcoming from the health establishment, the indigenous firm applied for a test licence on 6 August 2009, which it received from the Drug Controller, Himachal Pradesh. After getting the licence, the firm contacted the ICMR and different centres where other validations are done.
During this period, there were some media reports expressing doubts about the efficacy of the imported kits. The kits, the reports alleged, could carry out only 20 tests at a time, thus delaying the results.
When Tehelka met Dr Katoch, he insisted, “The government is carrying out the tests free of cost for the benefit of the people.” When he was asked to explain how the expenses could be different depending on the result, he replied that an additional test was carried out in case of negative results, thereby doubling the expenses.
It was under these circumstances that Dr Katoch was forced to convene a press conference on 11 August 2009 in which the then health minister Ghulam Nabi Azad also took part. Azad told the media that the ICMR would develop cost-efficient swine flu testing kits, but was silent on the product already developed indigenously, for which the ICMR and the DCGI did not give validation and licence. He also said that until then only a US-based company had the patent to develop the kit to detect the virus.
On 20 August 2009, Genome received an evaluation or validation report of 50 samples from Prof TN Dhole of SGPGI, Lucknow. The report stated, “We received a sample kit […] from Genome Diagnostics Pvt Ltd for evaluation and comparison of results as compared to the ABI kits currently being supplied by the Govt of India. We have tested and compared about 50 samples with both the kits on Rotor gene as well as the ABI Machine Rs 7500 and we find that the Indian Genome Diagnostics Pvt Ltd sample kit […] detected and confirmed 5/50 cases […] exactly as ABI.”
Moreover, the report stated, “The sample kit submitted by Genome Diagnostics Pvt Ltd performed much better than the ABI kit in terms of amplification and also the CT (cycle threshold) values was better than the ABI kit, which means that even low positives will be picked up better than ABI […] Hence, this kit is useful for primary screening and it should be approved for diagnostics usage.”
This evaluation report from Prof Dhole was sent to Dr Katoch, a fact which he corroborated.
A recap of what exactly transpired shows that rather than issuing the NOC, the ICMR asked Genome to get more validations:
♦ On 28 August 2009, a communication to the ICMR detailed all the information sought by it and informed it about the kits given to Dr Shobha Broor of AIIMS, New Delhi, and Dr V Ravi, hod, Neurovirology, NIMHANS, for validation
♦ On 9 September 2009, Genome received another letter from the DCGI in response to their letter
dated 10 August 2009 that they needed an NOC from the ICMR
♦ On 2 November 2009, another letter was shot off to Dr Katoch intimating him about the validation reports from NIMHANS and SGPGI. Dr Ravi confirmed that the evaluation report was issued by his laboratory
♦ On 16 December 2009, a letter from the DCGI again asked Genome to furnish an NOC from ICMR, which never came through
♦ However, after a long wait, on 21 June 2010, the firm received a communication from the DG, ICMR’s office inviting its representatives for a meeting on 30 June 2010. This meeting was later postponed to 1 July 2010. During the meeting, the DG, ICMR again asked for validation of 100 samples from Prof Dhole of the SGPGI
♦ On 7 December 2010, Prof Dhole submitted his first report about the kit to the ICMR
♦ On 2 February 2011, he submitted the second report to the ICMR, which validated the two versions of the kit. Both the results were in favour of the indigenous kit
The investigation into the episode led Tehelka to Dr Katoch’s office. Dr Katoch admitted that the government imported ABI kits at an exorbitant cost. Admitting to the lapses by the department, he accused his colleagues and said, “It made me very sad. It is a big blunder due to which ABI made a lot of money. The guilty will be punished.”
After two days, Tehelka met the CVO, ICMR. He said that if the ICMR had intervened at the right time, Genome could have got the required licence much earlier, thereby speeding up the detection process and saving many lives.
The CVO admitted the DCGI is the regulatory body that issues NOCs for manufacturing licences and the ICMR only makes technical recommendations. It thus becomes clear that for reasons known only to them, officials of the DCGI and the ICMR were colluding to deny licence to the indigenous manufacturer.
Voices from within the establishment tell their own story. Dr Rai of the NCDC said, “From 2009, the imported kits were used for swine flu detection. When the kits were being bought, as a member of the expert committee, I recommended Rs 4,000 to Rs 5,000 per test.” When we asked him how the cost could be different for positive and negative results for the same test, he said, “There is no logic at all. The idea was to make us look like fools.”
Dr MC Mishra, director, AIIMS, said, “Commercial interests are driving some vested interests into taking such decisions, especially when it comes to epidemics. When many people succumbed to dengue, many of my friends told me that every year these lab technicians buy new swanky cars. Somebody’s loss is somebody’s gain. It is a business for them.”
When Tehelka tried to contact Ghulam Nabi Azad, he was not available. However, a call was received after 10 days and when the former minister was informed about the investigation, he promised to go on record, but later his office started avoiding our calls. An email was also sent to him, but it went unanswered.
The same was the case with the health ministry officials, including the health secretary and joint secretary. After 15 days, we received a call from Dr Anshu Prakash, the joint secretary, to send our questionnaire to Dr Manisha Varma, PRO, which we did, but that, too, went unanswered. Tehelka also sent an email to the DCGI but is yet to receive a reply.
The Defence Research and Development Organisation (DRDO) has also developed a swine flu testing kit, which is being manufactured by RAS Lifesciences Pvt Ltd, Hyderabad. Each test on this kit would cost between Rs 400 and Rs 500. However, the firm was told by the director of the Institute of Preventive Medicine, Hyderabad, that indigenous manufacturers cannot approach any testing centres to directly sell their products. It has to be done only through the government. So, even though the firm got the approval from ICMR and the NOC from the DCGI in 2012, it has so far not been able to begin selling its kits.
Almost to a point of unanimity, the comments and reactions of those who were at the helm of affairs prove without doubt that the health ministry was engaged in a shoddy cover-up and a pack of blatant lies and half-truths was the staple diet. Under the garb of following due procedure, the system all this time sought to protect the corrupt and the inefficient, thus putting thousands of lives in danger.