Down To Earth filed an RTI application to find out the reason of vaccine shortage in India. The response revealed how a plan to promote private vaccine makers boomeranged. The health ministry was forced to get vaccines illegally from the very public sector manufacturers it suspended last year
Get your own vaccine
Shuvam Kumar lay on an iron cot in the tetanus ward of the Nalanda Medical College and Hospital in Patna, Bihar. After four days in the hospital, with stiff jaws and high fever, the two-yearold was too weak to cry when the nurse gave him an injection. There is little hope left of his survival, the family had been informed. His father, a labourer in Galurghat village in Gaya, regrets not getting Shuvam to Patna for the tetanus vaccine immediately after he stepped on a nail in the village. Shuvam was not administered the vaccine after birth either. The vaccine is not available in the village.
Rickshaw pullers outside the hospital refer to the tetanus ward as the bachcha murda ghar (morgue for children). Last year, 700 patients suffering from tetanus, diphtheria and whooping cough were admitted to the hospital. 300 died. The deaths happened because as infants they were not given the essential vaccines, the head nurse said as she stacked the patient record register among other files in a rusted iron rack (see box: Universal Immunization Programme).
Universal Immunization ProgrammeTo keep six contagious diseases at bay
The programme’s mandate is to enhance vaccine production in the country, among others. Started in 1978, it is now part of India’s National Rural Health Mission and involves vaccination against six contagious diseases: tuberculosis, diphtheria, pertussis, tetanus, polio and measles.
TUBERCULOSIS: A bacterial disease; BCG vaccine administered at birth. The vaccine protects from meningitis and TB.
DIPHTHERIA: A bacterial infection that affects tonsils, pharynx, larynx and the skin. It leads to degeneration of nerve cells and can cause loss of movement and sensation. About 10 per cent of diphtheria patients die, even if treated.
PERTUSSIS: Also called whooping cough, it is a bacterial infection. Coughing fits usually cause vomiting and infection of the ear, and can last up to eight weeks. In 2000, 39 million cases and 297,000 deaths occurred worldwide due to pertussis.
TETANUS: A bacterial disease characterized by muscle spasms. Starts with the jaw muscles. The toxin produced by the bacterium can lead to seizures, which can be fatal. The DPT (diphtheria-pertussis-tetanus) vaccine is administered in the 6th, 10th and14th week, and once when the child is 16-24 months old.
POLIO: A virus that multiplies in the intestine, from where it can invade the nervous system and cause paralysis. Vaccine dosage is the same as DPT. Additional doses are now being given to control the disease.
MEASLES: A viral disease. Symptoms include high fever, bloodshot eyes, white spots inside the mouth and rashes. The virus can cause blindness and pneumonia. Vaccine administered within nine to 12 months of a child’s birth
Overall, there is no reliable data on the number of deaths due to vaccine-preventable diseases in India. Back at the ward, a resident doctor said they expect more such patients.
The health ministry had shut its public sector vaccine-manufacturing units. “There are some sectors the government should stay invested in. Vaccination requires free distribution. Private companies are driven by profit, not welfare,” said Sunil Aggrawal, the doctor. Suspension of the manufacturing licences of the units on January 15, 2008 resulted in shortage of vaccines (see box: Vaccine shortage in India).
Vaccine shortage in India
In December 2008, a team of health ministry officials toured 13 states to review the National Rural Health Mission. They found, among other things, hospitals in Bihar did not have vaccines for diphtheria, whooping cough and tetanus. The review also reported shortages in Assam, where measles vaccine was not available; in Chhattisgarh, measles vaccine was in short supply; in Kerala, DT (diphtheria and tetanus), TT (tetanus toxoid) were in short supply in the primary healthcare centres in Thiruvananthapuram. In Uttar Pradesh, DPT and TT were not available.
Orissa too faced shortage in 2008, Down To Earth found out. Banmali Jena, doctor at the Botarma community health centre in Khurda district, said DT vaccine was not available from April to December 2008 and DPT vaccine in August and September. “We had to send back people. It was an ordeal to convince them that things would improve,” said Ghaneswar Sahoo, Jena’s colleague.
Orissa state joint director, rural health, Dina Krishna Panda admitted the state faced a shortage of BCG in February and March. P Sitaram, the chief district medical officer of Rayagada district, said there was no supply of BCG vaccine since March this year. “We usually keep a buffer stock, but in December 2008 our stocks were exhausted,” said Vijaya Balpande, medical officer with the Nagpur Municipal Commission’s health department. In Bangalore, parents took children to private hospitals where it cost them double the amount.
The former health minister admitted in Parliament that vaccine shortage had affected India’s vaccination programme in 2008. Ramadoss said compared to 2007, availability of DPT doses between April and December fell by 3.5 million in Bihar, 6.2 million in Uttar Pradesh and 3.3 million in West Bengal.
According to the health ministry’s data, compared to 2007-08, DPT vaccination in 2008-2009 (from April to November) fell by 29.5 per cent in Orissa and 36.2 per cent in West Bengal. BCG vaccination fell 7.9 per cent in Uttar Pradesh and 11.5 per cent in Punjab.
The ministry’s choice was private players. But that did not work.
In October 2008, Panabaka Lakshmi, former minister of state for health and family welfare, said private vaccine manufacturers had enough capacity to meet the requirement of India’s immunization programme. But there were problems in procurement, she said in the Rajya Sabha.
Left with little option
Shortage of vaccines was rampant between April and December. The former health minister Anbumani Ramadoss admitted this in Parliament in December. What he did not mention was the ministry had to go back to the public sector to end the shortage. Down To Earth (DTE) learned this through a Right to Information (RTI) application. Why did the health ministry target the three units that meet 80 per cent of the vaccine requirement of the Universal Immunization Programme? It was a move to protect business.
The three units that got suspension letters were: Central Research Institute (CRI) in Kasauli, Himachal Pradesh; BCG Vaccine Laboratory (BCGVL) in Chennai and Pasteur Institute of India (PII), Coonoor, both in Tamil Nadu. An inspection, by a team comprising WHO and health ministry officials, found the units did not meet the good manufacturing practices of the WHO and pointed out several deficiencies in these units. This put a question mark on the ability of the National Regulatory Authority to monitor the industry. The National Regulatory Authority is a body under the health ministry that grants or cancels licences to vaccine manufacturers (see box: India’s vaccine checks).
India’s vaccine checks
Not good enough, says WHO
2001: India’s Drugs and Cosmetics Act is amended to meet interna - tional standards; inclusion of National Regulatory Authority (NRA) and WHO’s Good Manu - facturing Practices (GMP). NRA is a body that, among other things, inspects whether vaccine manufacturers follow WHO’s GMP
2004: WHO inspects public sector vaccine manufacturing units
August 2004: Amended Drugs and Cosmetics Act comes into force
August 2007: WHO inspects again, says NRA has not ensured GMP compliance
September 2007: Health ministry conducts meeting to discuss WHO report. Asks public sector unit (PSU) heads to come up with a plan to create new facilities and create buffer stocks
December 2007: Secretary, health and Drugs Controller General of India, make a presentation to WHO in Geneva on action taken. They assure WHO if the units don’t comply, the licences would be revoked
January 2008: Health ministry team inspects the units
January 16, 2008: Licences suspended
February 6, 2008: Ministry decides not to use existing stock of vaccines
April 2008: Ministry’s expert committee assesses PSUs
September 18, 2008: Based on the committee report, additional secretary of health ministry assigns alternative uses to the units
Meeting WHO standards makes business sense for India. WHO certification helps procurement agencies like the UNICEF assess the quality of vaccines for immunization programmes the world over. About 60 per cent of the world’s vaccine supplies are from India. Allowing the units to continue could lead to disqualification for export of vaccines to the tune of Rs 1,500 crore, said Naresh Dayal, secretary, ministry of health and family welfare, at a press meet. Disqualification would have serious impact on export of other drugs as well. It could mean losses of around Rs 24,000 crore annually, Dayal added.
A parliamentary standing committee on health and family welfare, formed in July 2008, looked into the suspension decision. It said there were gaps in the ministry’s logic of shutting down the units and recommended the units should be restarted. Its report, submitted in February this year, raised questions on the procurement in 2008-09. The report said the ministry had distributed vaccine orders among three manufacturers at random: Serum Institute of India in Pune, Biological Evans and Indian Immunologicals Limited (IIL) in Hyderabad. IIL is a public sector enterprise under the National Dairy Development Board. The parliamentary committee said a chunk of the orders were given to Biological Evans, whose good manufacturing practices’ status was not clear.
Stealthy steps, now exposed
A note dated February 13, 2009, prepared by Sujaya Krishnan, director of the empowered procurement wing of the ministry, said private manufacturers had hiked prices and not supported the nation during a crisis.
The vaccine cost for diphtheria, pertussis, tetanus and BCG for 2008-09 turned out to be Rs 64.29 crore, compared to Rs 32.20 crore the previous year, revealed a confidential ministry document (see tables on p 31). This was despite the lesser quantity of vaccines procured in 2008-09. The total procurement of DPT vaccines from private units in 2008-09 was 144 million doses compared to 168 million in 2007-08 from both the public and private sectors. For BCG, the government ordered 60 million doses in 2008-09, compared to 80 million the previous year. The private industry says its rates are higher because it invests a lot in its products (see interview.)
Ministry should give a fair price to private sectorCYRUS S POONAWALLA, chairperson and managing director of Serum Institute of India Ltd, a private vaccine manufacturer, says the vaccine shortage is a mess the government created. Edited excerpts:
Except for polio vaccine, we can provide all vaccines required for the Universal Immunization Programme. Whatever orders were placed have been completed on time.
On vaccine shortage:
It was the health ministry’s procurement department’s fault. It did not place adequate orders to the private sector on time under the garb that we charge more. Can you believe that the private sector wanted half a rupee more per dose than the ridiculous price of Rs 1.50 per dose of DPT vaccine. This has caused disruption in supply and manufacture. Unfortunately, media and politicians highlighted ‘closure’ of the public units as the reason.
On current orders:
We have got orders for BCG vaccine and a small quantity of tetanus vaccine. In 2008-09, the government ordered 30 million doses of DPT, which we supplied at Rs 1.40 per dose to tide over the shortage. This year, instead of giving us substantial orders to keep the supply line going, the ministry chose not to give us any orders for DPT vaccine because we charged four paise more per dose. We are an international manufacturing unit whose quality the public sector cannot match.
On public sector:
The ministry had little choice but to suspend operations of the public sector, which were wasting public funds and producing vaccines under appalling conditions. One of the reasons the public sector could not upgrade its facilities to the current GMP (good manufacturing practices) was the low price that the health ministry forced on them and the private manufacturers. To make them GMP compliant now would be further waste of money and duplication. The few hundred staff members could be utilized elsewhere for tests or research.
A vaccine such as DPT for which hundreds of crores of rupees are to be invested for a sophisticated plant, cannot be produced and delivered to its destination at two rupees. You don’t get a cup of tea or chew paan at that price. The procurement department should wake up to the reality and give fair price to all manufacturers, whether private sector or public.
The government had of course not factored this in while suspending the licences. It reduced the procurement budget for vaccines from Rs 140 crore in 2007-08 to Rs 138 crore in 2008-09. According to C M Gulhati, editor of Monthly Index of Medical Specialities, the move is a conspiracy to include private companies into the business of vaccines for the Universal Immunization Programme. Bribes, he said, are not possible from the public sector.
On December 23, 2008, the prime minister’s office (PMO) had questioned the ministry. Left leader T K Rangarajan had sent the questions to the PMO. He raised the issue of additional costs of the vaccine procured from private players and impact of the closure on the Universal Immunization Programme. He also wanted to know if any effort was made to revive and make the public sector compliant with WHO’s good manufacturing practices.
The PMO asked the ministry for a reply by December 29, but hasn’t got any response yet. “We want an inquiry. We are not looking for character assassination of the health minister,” said Rangarajan.
But answers are difficult to come by. Sanjai Sharma of the Human Rights Law Network, a non-profit in Delhi, had filed an RTI application in February this year. Sharma had sought reports of WHO teams since 2000 and Parliament’s standing committees on the status of vaccine manufacturing units. He was told a month later that the request for WHO reports was forwarded to the Drugs Controller General’s office. For the standing committee reports, he was asked to look up Parliament’s website. DTE filed the RTI application for clarity on:
Ã”Ã¹Ã… Reasons and implications of the suspension
Ã”Ã¹Ã… WHO’s assessment reports
Ã”Ã¹Ã… Details of vaccine procurement
Ã”Ã¹Ã… All communications with the PMO
The health ministry did not give answers to most questions and diverted them to different departments. The two pages of response it sent, however, revealed the extent of the crisis: it had (illegally) procured 11.7 million doses of DPT, 3.7 million doses of DT and 12 million doses of TT from CRI in 2008-09. The ministry also approached BCGVL for vaccines but the unit turned it away. The unit’s director revealed this in an affidavit, which he gave in response to a petition filed by public health experts in the Supreme Court (see box: Allegations against former health minister).
Allegations against former health minister
Ramadoss compromised India’s interests
Health experts, politicians and even political allies questioned former health minister Anbumani Ramadoss’ decision to delicense the public sector units. After a year of inaction to revive the units, S P Shukla, former special secretary, family welfare and a group of public health experts filed a petition in the Supreme Court in February 2009. The petition accused the then health minister of taking decisions that undermined the country’s self sufficiency in vaccines for the Universal Immunization Programme. It claimed the drug controller general of India along with directors of the suspended facilities helped Ramadoss.
The petition pointed out N Elangeswaran, director of BCGVL and PII, facilitated crucial resources transfer to private companies, the Green Signal Bio Pharma in Chennai, for example.
Sundaraparipooranan, who belongs to Ramadoss’ party PMK, owns the company. Another Chennai-based vaccine company called Vatsan Bio Pharma that came up in 2006 is coowned by Sundaraparipooranan and his wife. Elangeswaran’s wife is the major shareholder in it.
The petitioners also allege that N Elangeswaran, in November 2006, purchased measles seed (the basic raw material to make a vaccine) from Green Signal Bio Pharma. Indian Immunologicals Ltd, a public sector undertaking in Hyderabad, could have provided this seed for free.
The health ministry sanctioned Rs 17.80 crore to PII for branching out into measles vaccine production after it entered into the deal with Green Signal Bio Pharma. The deal ensured PII would produce measles vaccines but give away 70 per cent of the profit to Green Signal Bio Pharma as royalty.
Despite the crisis now, the ministry only has long-term plans. It has commissioned HLL Lifecare Limited a Rs 900- crore Integrated Vaccine Complex in Chengalpattu, near Chennai. HLL is a public sector unit with no experience in vaccine manufacture. The ministry plans to make the complex compliant to WHO’s good manufacturing practices. “HLL would own the facility, manufacture and supply high quality vaccines at affordable prices to the government,” said K R S Krishnan, executive director of the company.
The complex will manufacture vaccines for India’s vaccination programme along with new generation vaccines. For conventional vaccines, the technology would be sourced from the public sector. For the rest, it would enter into partnerships with the private and public sector and companies in India and abroad. The complex is likely to be completed in 2011. In the first phase, bulk vaccines procured from private manufacturers will be repackaged. There is no timeline for manufacturing yet but the company claims its prices would match the lowest in the market.
“Five years from now,” said Krishnan, “our prices would be 50 per cent of UNICEF’s procurement prices.” He refused to divulge price details.
No effort to revive public sector
The question public health experts are asking is if the vaccine complex can meet the good manufacturing practices, why can’t the same be done for the existing public sector facilities in India. In fact, after inspecting the public sector manufacturing units, WHO had offered funds and technical support to the ministry. The assistance was to make the units compliant to its good manufacturing practices. The parliamentary committee in its report had asked the ministry why it did not take the offer then. In 1997, CRI Kasauli had submitted a proposal to the health ministry to upgrade its DPT vaccine laboratory to good manufacturing practices. The ministry commissioned the work to HSCC Ltd, a consultancy firm in Noida. Nine years later, its chairperson met the health secretary and said the firm did not have the expertise for the project.
This after the ministry had given the company Rs 11.86 crore of the Rs 13.29 crore sanctioned for the project. CRI then sent a fresh proposal to the ministry and the director general of health services on December 3, 2007. The proposal was forwarded to the drugs controller general of India for comments on January 30, 2008, but the suspension order was out by then. It’s no surprise that the institute was operating without a director since 1997 and faced a staff shortage of 24.3 per cent, including scientists.
There was a 27 per cent staff shortage in BCGVL, mostly in the technical field. By July 2008, the institute had spent Rs 1.2 crore, renovated some of the facilities, which addressed the deficiencies pointed out by WHO. They needed another six crore rupees and one more year to complete the work, but the ministry had not shown any interest in reviving the unit.
Questions on revival of the units in Parliament received no responses last year. In February, Lakshmi acknowledged they received a proposal to upgrade facilities at CRI Kasauli. WHO experts had examined it and said the plan was feasible. She added that production of vaccines could restart after complying with WHO’s good manufacturing practices.
But sources said the whole of CRI is not being revived. The DPT unit has received more than Rs 250 crore. WHO wants the new facility completed by November this year. Similar plans are being made for PII and BCGVL . Work has barely begun at CRI. The units will start providing vaccines after they meet good manufacturing practices. The process is likely to take long and until then India is at the mercy of the private sector.
Delicensing public sector has another advantage. Agencies like the World Bank and the Asian Development Bank provide funds to vaccine manufacturers to meet good manufacturing practices. These are available only when WHO has certified the National Regulatory Authority. If the public sector does not exist, the money goes to private players. V M Katoch, director of the Indian Council of Medical Research, said public sector units serve the nation well. The new health minister Ghulam Nabi Azad has been briefed on the subject.
This is not India’s first attempt to kill a public sector enterprise. In 1997, the government had stopped production of the polio vaccine at PII in Coonoor because there were questions on the vaccine’s quality. Vaccine production at Haffkine Institute, Mumbai, was also stopped.
Like the Integrated Vaccine Complex planned in Chengalpattu, the department of biotechnology set up a public sector facility, Bharat Immuno logicals and Biologicals Corporation Ltd, to meet the polio vaccine requirement.
In its first phase, the company imported bulk of oral polio vaccine from Russia. It was supposed to repackage them and begin manufacturing in five years. The government declared the company a sick unit in 2000. India now imports polio vaccine from Indonesia and Italy and repackages them. Little has changed since. There are new victims. Shuvam Kumar, among them, continues to be in a critical state at the Patna hospital. 25 million newborns are at risk every year.
Inputs from Ashutosh Mishra, Alok Gupta, Aparna Pallavi and Deepa Kozhisseri
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