‚ÄĘ A member of the expert committee for swine flu said, ‚ÄúWhen the kits were being bought, I suggested that Rs 4,000 to Rs 5,000 per test was enough‚ÄĚ
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, ‚ÄúThe government is carrying out the tests free of cost for the benefit of the people.‚ÄĚ 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, ‚ÄúWe 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.‚ÄĚ
Moreover, the report stated, ‚ÄúThe 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.‚ÄĚ
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:
‚ô¶ 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
‚ô¶ 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
‚ô¶ 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
‚ô¶ On 16 December 2009, a letter from the DCGI again asked Genome to furnish an NOC from ICMR, which never came through
‚ô¶ However, after a long wait, on 21 June 2010, the firm received a communication from the DG, ICMR‚Äôs 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
‚ô¶ On 7 December 2010, Prof Dhole submitted his first report about the kit to the¬†ICMR
‚ô¶ 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‚Äôs 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, ‚ÄúIt made me very sad. It is a big blunder due to which ABI¬†made a lot of money. The guilty will be punished.‚ÄĚ
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, ‚ÄúFrom 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.‚ÄĚ When we asked him how the cost could be different for positive and negative results for the same test, he said, ‚ÄúThere is no logic at all. The idea was to make us look like fools.‚ÄĚ
Dr MC Mishra, director, AIIMS, said, ‚ÄúCommercial 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‚Äôs loss is somebody‚Äôs gain. It is a business for them.‚ÄĚ
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.