New Delhi: Rs 400 crore: The cost of vaccines purchased by the Modi government in 2019 as part of an ambitious programme to eliminate foot-and-mouth disease, which has plagued Indian livestock for a century, by 2030. The vaccines were procured from three companies: Brilliant Biopharma Pvt Ltd, Biovet, and the public sector Indian Immunologicals Ltd.
Rs 1,250 crore: The estimated expense incurred on storing the vaccines, transporting them to states, syringes, among others, and payments to those administering the vaccine.
Result: The programme hits a wall in 2020. All the vaccine batches are recalled because tests reveal some of the samples don’t comply with quality criteria listed in the tenders. The decision is conveyed to states and union territories in a letter from the Union Ministry of Fisheries, Animal Husbandry and Dairying. The vaccines of all three companies, government sources told ThePrint, were found wanting on quality parameters.
Foot-and-mouth disease (FMD) is a highly contagious viral condition that affects cloven-hoofed animals like cattle and goats. The Indian Council of Agriculture Research (ICAR) says it is associated with death of young animals, marked reduction in milk yield, abortion in advanced stages of pregnancy, and reduced working ability of drought animals, besides a decline in quality of meat.
With months of efforts on the vaccination push coming to a naught, questions have arisen over why the vaccines were distributed, even administered in some cases, before they were tested. And how the government aims to recoup the money spent.
ThePrint called the office of the Minister for Fisheries, Animal Husbandry and Dairying, Giriraj Singh, for a comment but there was no response despite several attempts.
Director General of PIB, Jaideep Bhatnagar, was also contacted repeatedly through email and text messages. He said he had sent the questions to the concerned officer but there was no response until the time of publishing this report.
ThePrint reached Upamanyu Basu, joint secretary in the ministry, who wrote the recall letter to states and UTs, through phone calls for comment but there was no response until the time of publishing either. Atul Chaturvedi, the secretary for the ministry, did not reply to questions sent via email.
Ministry spokesperson Manish Gautam asked ThePrint to send a detailed questionnaire to the ministry, which remained unanswered until the time of publishing.
Responding to ThePrint report Sunday, a day after it was published, the Department of Animal Husbandry and Dairying said there would be no loss to the government or farmers due to the ineffective vaccines.
In a note shared by the Secretary, Atul Chaturvedi, with ThePrint, the department said the cost of vaccines and vaccinations will be compensated by the manufacturers to the government.
It also said that testing for the next round of vaccination has already begun, and the quality batches by one of the manufacturers has already cleared the tests.
“The supply orders for these passed batches of FMD vaccine have been placed and vaccine doses are expected to reach the field in the coming weeks, despite the ongoing challenges of COVID 19,” the note said.
ThePrint reached the three vaccine manufacturers by email for a comment, but there was no response despite reminders to each of them.
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‘Withhold vaccination’
In 2019, Prime Minister Narendra Modi launched a Rs 13,000 crore vaccination programme for cattle, buffalo, sheep, goats and pigs to finally control FMD and another disease, brucellosis, by 2025.
It was announced as part of the government’s effort to double farmers’ income, with an aim to finally eradicate the diseases from India by 2030 under the National Animal Disease Control Programme (NADCP).
As part of the NADCP, for which the Union Budget announced a total outlay of Rs 13,343 crore last year, the central government was supposed to procure vaccines for the diseases, and distribute them to all the states and UTs over the next five years.
According to government officials, the FMD vaccines were purchased from the three companies for Rs 400 crore, and were subsequently distributed to all the states and UTs barring Bihar and West Bengal. The entire operation, they said, cost Rs 800 crore in 2019-20, including the Rs 400 crore paid to the three vaccine companies, and Rs 850 crore in 2020-21.
However, in letters written to the animal husbandry departments of different states and UTs from September to December 2020, the Union Ministry of Fisheries, Animal Husbandry and Dairying said the quality control of some of the FMD vaccines were not in compliance with the parameters stipulated in the tender for procurement. The vaccination should, therefore, be withheld, it added.
For example, in the letter to the governments of Andhra Pradesh, Uttar Pradesh and Madhya Pradesh dated 20 November 2020, joint secretary Basu said: “I would like to draw your attention to the fact that this department has devised a mechanism for quality control test of FMD vaccines supplied to the states/UTs under the NADCP for FMD and Brucellosis. The quality standards for procurement and supply of the FMD vaccines along with the requisite penalties for failure to comply with the quality standards have been prescribed in the tender document.
“The results of the quality control for some of the samples of the FMD vaccine have been received from the Head, Division of Biological Standardisation, ICAR-IVRI (the Indian Veterinary Research Institute under the Indian Council of Agricultural Research) where from it is found that 03 batches of the FMD vaccine manufactured by M/s. Indian Immunological Ltd. Hyderabad and supplied by NAFED (National Agricultural Cooperative Marketing Federation) to various states, including your state, did not comply with the quality parameters stipulated in the tender for procurement,” he added.
“I therefore request you to kindly withhold vaccination/re-vaccinate, if vaccination is already done, after replacement of the failed vaccine batches including the corresponding batches and inform compliance at the earliest and await further communication,” Basu wrote.
ThePrint has accessed a copy of the letter written by Basu to the governments of Punjab, Rajasthan, Assam, Jammu and Kashmir, Jharkhand, Chhattisgarh, Arunachal Pradesh, Karnataka, Uttarakhand, Delhi, Tripura, Meghalaya, Nagaland, Manipur, among others.
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Why were vaccines distributed before testing?
Asked why the samples were tested after distribution, a senior official in the ministry said since testing takes a long time, the vaccines were distributed to states and UTs before the results came in. However, the moment it was discovered that the vaccines are “ineffective”, recall orders were issued, the official added.
“Testing takes a long time, and because of Covid last year, everything had been delayed,” the official said. “But now, we have done the testing of the vaccines from our three manufacturers, and new vaccines will be distributed starting this month,” the official added.
Asked about the financial loss incurred by the government due to the exercise, including the logistical expenses, the official said it has not been quantified. “We are trying to recover the payment from the manufacturers,” the official said.
Since the replacement orders have been made to the same manufacturers, the official added, the government will not have to pay for the new vaccines.
While the official said the loss hadn’t been quantified, other government officials told ThePrint that Rs 400 crore was spent on purchasing the vaccines, with another Rs 1,250 crore spent on logistics, including storage, and travel and syringe costs, in the last two years.
The official quoted above said there are a number of challenges with which the government is trying to implement this scheme. “It is a very ambitious scheme, and, of course, there will be hurdles. But the programme has not got derailed. You see, vaccinations are inherently a tricky area. We are seeing that unfold with the Covid vaccinations as well,” the official added.
“But this time around, we have stringent quality control and testing, so the scheme will be implemented,” the official added.
FMD a challenge for India decades later
While announcing the ambitious scheme, minister Giriraj Singh had sought to explain its importance.
“We aim to eradicate FMD and brucellosis diseases fully as it has been done in the case of polio and tuberculosis in human beings. If a cow or buffalo gets infected with FMD, the milk loss is up to 100 per cent, which could last for four to six months,” he said in 2019.
Sanjeev Balyan, the minister of state for the ministry, said FMD costs the country Rs 18,000-20,000 crore in revenue every year.
FMD has been eradicated in most developed countries, with India among the few still grappling with it, veterinary experts say.
According to the ICAR, FMD “continues to be the most widespread viral disease affecting bovines as well as small ruminants” in India. “The economic loss due to FMD is tremendous that occurred due to death of young animals, marked reduction in milk yield, abortion in advance stage of pregnancy and reduced working ability of drought animals, decline in quality of meat, reduction in fertility and poor quality of semen in breeding bull etc,” it added.
An animal infected with FMD develops lesions on the nose and lips, tongue and in the mouth, on the teats, and between the toes. The condition is also associated with painful ulcers.
The disease affects the mouth of the animal by causing the flow of a heavy and sticky, foamy saliva, and makes the feet of the animal tender, thereby making the animal sway from one foot to another. Animals affected are known to develop high fever, loss of appetite. They are unable to lactate, and may become lame.
Speaking to ThePrint, Dr Chirantan Kadian, chairperson of the Indian Veterinary Association, a professional organisation, said the vaccination recall episode “has not been just a monetary loss, but has also been devastating for animals, who have continued to suffer despite being supposedly vaccinated”.
“Everywhere, the norm is to pretest before the vaccine is administered…FMD can be eradicated 100 per cent if the government administers tested vaccines on animals, but that is not done,” he added. “Even now, to the best of our knowledge, no steps are being taken to restart the vaccination programme…this was a great initiative by the PM, yet nothing was done.”
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Cost will be recovered by manufacturers, says govt
The note shared with ThePrint by Secretary Atul Chaturvedi said that some of the amount spent by the central government on building the infrastructure for the vaccine programme will continue to be utilised and is not lost.
“The implementation of the programme started in 2019-20. The total expenditure incurred under the programme since then is Rs. 1669 crore. This includes expenditure towards creating cold chain and related expenditure in States/UTs amounting to Rs. 293 crore, which will continue to be used for all vaccination programmes being implemented by them,” the note said.
“This also includes expenditure of Rs. 538 crore towards ear tags, tagging etc, which will again be used for tracking health and productivity status of animals throughout the lifetime of that particular animal.”
The vaccine procurement and vaccination costs will be recovered from the manufacturers, it added.
On the issue of why untested vaccines were distributed by the Centre, the department has said, the nationwide lockdown imposed last year was responsible for the “jolt” felt by the programme.
“Logistics and transportation issues affected the operations of vaccination and sample collection needed for the testing, thereby delaying the vaccine quality testing process,” it said. “People’s apprehensions due to the COVID-19 pandemic also limited willingness of the scientists, responsible for vaccine testing to travel. All these affected the testing operations in the laboratories.”
However, in order to contain the outbreak of FMD, the vaccine distribution was continued irrespective, the statement added. “Based on the reports of quality testing received by the Department, certain batches passed the quality control tests,” it said. “However, the remaining batches, though found to have passed the sterility and safety tests did not comply with the desired benchmark for potency.”
While the manufacturers have withdrawn the defective batches and are in the process of destroying the unutilised FMD vaccines from these batches, it should be noted “this quality failure of the FMD vaccine has not resulted in any financial loss to either the Government or to the livestock farmer, as the cost of vaccine and vaccination will be compensated by manufacturers”.
(This report has been updated to include the response from the government)