Cancellation of vaccine-manufacturing public enterprises’ licenses: AIDAN calls for a rethink

The All India Drug Action Network (AIDAN) is a national network of organizations that have been working on pharmaceutical policy issues since the early eighties. Reacting to the news of cancellation of licenses of three vaccine-manufacturing public enterprises, namely the 103-year-old Central Research Institute (CRI), Kasauli; the 100-year-old Pasteur Institute of India (PII), Coonoor; and the 60-year-old BCG Vaccine Laboratory (BCGVL) in Chennai, the All India Drug Action Network (AIDAN) has issued the following statement:

While there should be no compromise on the quality of medicines and vaccines produced, the cancellation of the licenses for the three vaccine-manufacturing public enterprises under the Ministry of Health and Family Welfare smacks of arbitrariness, and a planned attempt to kill these institutions and clear the way for private companies to operate in a segment which serves a critical national need – the production of vaccines for the large Expanded Program of Immunization. Recent newspaper reports of alleged nexus between the Ministry of Health and Family Welfare and a private vaccine manufacturing company in blatant disregard of the public responsibilities of their role, use of coercion to effect closure of vaccine production units with a proven record of safety and quality, and the comments in the preliminary audit report of the Comptroller & Auditor General (CAG) [i] point to an unprecedented disregard for public good.

The Minister of Health and Family Welfare, Dr. Anbumani Ramadoss has said that the enterprises were ordered to suspend production for non-compliance with good manufacturing practice (GMP). This gives rise to many issues:

1) Since the public enterprises were under the Ministry of Health and Family Welfare, and had been requesting for assistance to upgrade their facilities since the past many years , what did the Minister of Health and Family Welfare, do over the past 4 years to ensure their compliance with newer norms? While the Government is planning to spend Rs. 300 – Rs 500 crore to develop the upcoming vaccine and medical park in Chengalpattu which will become operational in 2012, why were these three enterprises which were engaged in vaccine production since decades not provided with the Rs. 50-60 crores they required? Who will supply vaccines in the interim, and at what cost?

2) The closure of vaccine production in these units comes at a time, when the demand-supply in vaccines for India’s Expanded Program for Immunization (EPI) is widening, private companies are pushing expensive cocktails of the EPI vaccines with other vaccines in the market, and coverage of immunization against these crucial vaccine preventable diseases is declining.[ii] The closure of production of these vaccine producing units will have enormous implications for the cost and access to these vaccines in the future.

3) While the Ministry has acted with alacrity and closed down production in public sector units, it has dragged its feet in matters where private pharmaceutical companies are involved, even if the issues are of crucial concern to people and public health. A few instances of these are:

a. Action is curiously lacking in the matter of regulation of drug quality with only 17 testing laboratories in the entire country, and only 7 which can be termed fully functional, as per the Mashelkar report in 2005.

b. Action is also curiously lacking against private companies which continue to manufacture hundreds of formulations which the Drug Controller General has admitted in Court as lacking his approval and are therefore illegal.

c. Action is curiously lacking in the matter of hazardous drugs like Nimesulide, which are freely promoted in India for use in children, while it is banned for use below 12 years in the European Union and not available in USA, Canada, Australia or even in neighbouring Sri Lanka.

d. The Health Ministry also does not seem concerned with the low availability of essential medicines in public health facilities [iii] or the increasing unaffordability of drugs in India.

e. The Health Ministry is not known to have taken any stand or action when competitive medicine brands are sold at an entirely inexplicable 1000% price difference or where drugs are provided to the retailer at even 5-10% of their retail price, or where any attempt at regulating the retail prices are vociferously challenged by the pharmaceutical companies. Even if by a curious anomaly, the pharmaceutical policy is formulated by the Ministry of Chemicals, has the Ministry of Health and Family Welfare ever articulated these concerns, which are creating misery for millions?

In this context, the entire sequence of events over the past few years, with allegations of purchase of raw material for measles vaccines at inflated cost from private companies, providing them raw material from these 3 units at either free or at ridiculously low prices, and further agreeing to give 70 per cent of the profit from vaccine manufacturing to the private company needs an enquiry at the highest level.

The All India Drug action Network (AIDAN) calls on the Government to stop playing games with the health and lives of innocent children and with the pharmaceutical security of the nation, in its attempts to pave the way for private enterprise. The falling rates of immunization are a blot on the functioning of the Government, especially the Ministry of Health and Family Welfare and the state health departments. Efforts must be made to ensure safe and steady supply of cost-effective vaccines and universal immunization of children. To ensure this, the robust functioning of public enterprises like CRI, Kasauli, PII, Coonoor, and BCGVL, Chennai are essential. We call on the Government to reverse with immediate effect its directives on the functioning of these enterprises and to ensure all assistance to make them compliant with newer norms.

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[i] “…the heedless decision by the Ministry/Drugs Controller, without ascertaining all the factors, is not acceptable to audit. BCG Vaccine Lab is not a private company; it is a 100 per cent Government of India department. If there is any deficiency in modernisation of building as per norms of WHO or system change in quality control, the Government should use all its force and concentration so that the unit is revitalised.”

[ii] The immunization coverage of children among 1 year olds in India for 3 doses of DTP has come down from 70% in 1990 to 55% in 2006. In contrast, the global figures indicated an increase from 75 to 79% for the same period. These figures were released by World Health Organisation (WHO) in its latest publication World Health Statistics 2008. The Third National Family Health Survey (NFHS-3) had earlier shown that the percentage of children between 1 and 2 years who had received all recommended vaccines had also come down from 61% to 58% in urban areas between the period of NFHS-2 (1998-99) and NFHS-3 (2005-06).

[iii] In a study done in 6 states and published in the May 2007 issue of the Indian Journal of Medical Research, the availability of essential medicines varied from 0% to 30%.

Human rights violations by the Indian corporate sector – Case of ICICI bank

ICICI bank is becoming a sort of menace in recent times. They seem to be violating all codes of conduct and established business practices in their pursuit of growth and profit. What is worse is that they have begun to violate basic human rights of many of those who avail of its services. Today’s newspaper (Times of India, Mumbai, Nov 21, 2007, p.13) reports that ICICI bank was fined Rs.1,00,000 by the district consumer disputes redressal forum for sending loan recovery agents to the house of a lady in Pune at night, to seize her car, and for not following legal procedures. In another case, media reported about the bank’s agents in Goa accosting and beating up a man in broad daylight before snatching his car keys. CNN IBN also showed an entire episode of the ICICI bank’s misconduct in loan recovery and the involvement of its officials in a huge car loan recovery racket run in Goa. Earlier the Delhi state consumer disputes redressal commission had levied a whooping Rs.50,00,000 fine on ICICI bank for sending goons to take away a loaned car from a person who had defaulted on paying his loan instalments. The goons sent by the bank had taken the car after beating up the customer’s friend (who happened to be in the car) with iron rods, leading to serious injuries on his skull and other parts of the body. They also asked the bank to pay Rs.5,00,000 to the customer. Newspapers have reported widely about the violation of human rights by the bank, but the officials of the bank remain scot-free and continue to indulge in more violations. The Pune case is only an indictor of that. The Delhi Consumer Commission held the ICICI Bank guilty of “unfair trade practice,” and termed the miscreants as a boorish and a brutal lout, who care a fig for legal and judicial authorities, including the Supreme Court. Its President Justice J D Kapoor said “No civilised society governed by rule of law can brook such kind of conduct,” and added that the violent methods adopted by the recovery agents were serious violation of “human rights”.

Today, privatisation and public-private partnerships are touted as the big mantras of achieving basic human rights and services such as health and education for its citizens. ICICI bank’s practices are only indicative of the practices that an unregulated private sector can indulge in, to maximise their profits, even at the cost of safety of human lives. Relying on the unregulated private sector to achieve human rights will be like entrusting the wolves to take care of the lambs. Let the ICICI bank’s practices be a reminder of this!!!

Bloodshot eyes… year after year

We are now a small and a sick family. We have all fallen victim to Conjunctivitis (commonly called “pinkeye” or “Madras Eye” in India). It started off with my dad, and then spread to the entire family, including our little daughter. Newspapers in Mumbai are full of Conjunctivitis news. It is that time of the year, when Conjunctivitis is rampant in the city. When I called up my colleagues in Bangalore, two of them had also fallen ill and had not reported for work. So, if this is so common all over the country, and if people are not reporting for work, and there is say 2- 3 lost working days per person, imagine the gross loss of productivity. Forget the productivity; what is greater is the suffering and pain that one experiences. In an earlier posting,  I had written about the cost of treatment for diarrhoea in children. Now, treatment of Conjunctivitis is not cheap either. I think more than the medicine cost is the cost of consulting an eye specialist. So, in addition to the lost work days and pain and suffering, is the cost of treatment.

Conjunctivitis is highly contagious and quickly spreads from one to the other, so, just like in our family, the whole household usually gets infected very soon. We were very careful about not touching our eye and then touching each other, washing our hands often, not sharing towels and pillow cases, and so on; yet we all fell ill. So, one can only imagine in the slums where living spaces are so crammed and people have no other option but to share common resources, how easily it can spread.

The fact that Mumbaikars and people in other places around India suffer due to Conjunctivitis EVERY YEAR, around this time of the year (monsoon and post-monsoon) is almost like a foregone conclusion. Nobody even bats an eyelid (no pun intended) when hordes of people fall prey to this infection. In spite of having enough knowledge about the infection and knowing precisely when it strikes, we are unable to do anything to prevent it from happening year after year. So much for public health in our country! 

I had an interesting experience during the treatment of this infection. A drug which is commonly used in Mumbai (and other places also I presume) as first-line treatment for Conjunctivitis is a drug which contains corticosteroids, while the recommended treatment for bacterial Conjunctivitis (the most common, I think) is non-steroidal anti-inflammatory medications and antibiotic eye drops or ointments  I was told that schools here routinely stock the drug containing corticosteroids during monsoons, because of the high number of children who go to school with the infection. In fact, even I was advised by a friend to get this particular drug for Conjunctivitis. I did not not know about its contents. He said that anybody with Conjunctivitis vouches for the efficiency of this drug, and in fact this was most commonly prescribed drug by doctors everywhere. So, I went to the nearest chemist and asked for the drug. He laughed and said, that this drug was out-of-stock and I would have to procure it in black (paying almost double the cost) since there was huge demand for the drug. I walked away from the chemist in anger and went to another one. There, the same story was repeated. Finally, I decided to buy this drug, by paying that extra cost because my eye was hurting badly and I could not walk any further in the hot sun. Just after I had bought the drug, my wife called me to say that I should not use the drug as it contained corticosteroids and that it was usually used in the worst cases to reduce the discomfort from inflammation. On reading the label, I found that drug contained corticosteroids, and the warning said “indiscriminate and prolonged use of the drug could lead to glaucoma, cataract and fungal infections”. In fact, it can even cause permanent eye damage by inducing central serous retinopathy (CSR). Needles to say, the drug was a Schedule H drug (which was to be sold only on the prescription of a Registered Medical Practitioner), but I got it without even a single piece of paper. What is even more shocking is that, it is being used indiscriminately in schools and slums where people go and buy this from the Chemist across the counter at a price that the Chemist decides, because for most of the slum-dwellers, the Chemist also doubles up as their only “doctor”. 

I have uploaded some snaps of my Conjunctivitis-ridden eyes to show you the signs and symptoms. The first one shows the redness and watering from both the eyes, while the second one shows the swelling around the eyes, especially in the mornings. For more snaps, click here.

The mystique of medicine and the cost of treatment

How much does it cost to treat diarrhoea in children? A lot, as we realised when we came face-to-face with diarrhoea and the medical establishment, twice in the span of less than a month. I had written earlier about the water in our neighbourhood. Needless to say, our little one was down with her second bout of diarrhoea, in less than a month. We started out with homeopathy on both occasions. Our resolve to be patient and wait out until the infection dies out, was quickly overcome when we saw the condition of the child not improving.

The second time was worse than the first episode. A visit to the local doctor, not yielding any visible benefits, saw us rush for a consultation with a specialist pediatrician, who filled in two long sides of a prescription sheet with medicines and powders of different kinds. Banish any thought of rational medicines and good old home remedies! In fact, when we asked the doctor about some of the specifications of the medicines (more in the nature of clarification, rather than confrontation), he lost his cool and said “then why do you come to me?” – the arrogance of knowledge being mystified and given into a few hands!!! Anyway, we visited at least three different medical stores to get the array of powders and medicines – the hocus-pocus of modern medicines. The whole exercise in ignorance, set us back by about Rs.1000 (the second time). On closer examination, we realised that one of the costly powders was a substitute for its poor (but effective) and distant cousin – kanji (rice gruel), while another was a substitute for home-made ORS, and yet another was a replacement for milk (to not aggravate the loosies). As a parting shot, he also said that we need to get her stool tested, (but of course, the clinic also had a lab attached) and that in case she did not improve and pass urine in the next few hours, we had to get her admitted (and yes, he runs a children’s hospital also). No tips on how to take care of the child at home, or how to avoid hospitalisation – purely a “pill for every ill” or rather “a load of pills for every ill” approach.

 For more photos, click here.

Just opposite the housing colony where we live is a large slum. The children there, not only have access to the same (if not worse) water, but also have poor living conditions and all other typical features which characterise slums in cities. It was especially with reference to this slum, that the doctor has said “oh, diarrhoea, everybody gets it here”. If everybody gets it, and spends so much of their hard-earned money on the doctors and medicines, and syrups and tonics and lost wages, then why is nothing being done about it? One reason is definitely the mystique of modern medicine carefully preserved and crafted and refined by the practioners of the art, to keep common people from taking health in to their own hands. After all, if they do that, where will they make their living from? That’s the tragedy of commercialisation of medicine and medical education. Wither health for all???

We are like this only…

You wake up in the morning to the smell of brewing coffee. As you await your morning dose of newspaper, you decide to freshen up. You take those first few sleepy steps to the wash basin and suddenly you see RED and stop in fright….

But then you continue again, because you have to be brave, you have to wash your face, you have to brush your teeth, and you have to face those red worms that come along with the water, YOU HAVE NO OTHER ALTERNATIVE!!!

Dear friends, this is no scene from a horror movie, but a daily reality for those of us living around P.L.Lokhande Marg in Chembur. We are served with muddy water by the municipal corporation, filled with muck and different kinds of worms. They come in different shapes and sizes, but the wriggly squiggly squirmy red worms are the most common.

All our taps resemble wounded soldiers (well, they must all be deeply wounded – facing attack from the worms day in and day out). They are bandaged with different kind of filters – white cloth filters, plastic filters and fibre filters. But they fail miserably to stop the ingenious worms who make their way through the taps, into the water and straight into our unsuspecting mouths. A white cloth filter takes only a few minutes to become dark brown. I have taken a few pictures to share our story with you. I emptied out the worms from one of the tap filters into a basin and took some photos. (WARNING: Some of these images may cause dysentery, cholera and typhoid. Please view them only under medical supervision).

To see more photos click here.

An article in the Times of India, four years back (July 10, 2003) had reported about a study, which was conducted by the Society for a Clean Environment (Socleen) and funded by the Mumbai Metropolitan Regional Development Authority (MMRDA). The study which did random testing of piped water samples found that the level of fecal coliform (bacteria found in excreta)— one of the most important indicators of the safety of drinking water —was 1600 fecal coliform (fc) per 100 ml of water in P.L. Lokhande Marg, while the Bureau of Indian Standards’ safe norm is 10 fc per 100 ml.
The report also said that some of Chembur’s P.L. Lokhande Marg’s housing societies had the “worst water quality, with 70 per cent of the samples found to be unpotable”.

So friends, four years on, the situation has not changed. And as the famous by-line goes “we are like this only”. Probably, in another four years, I will post some more photos of the water here. Now I have to rush – I need to visit my neighbours and friends from the area who have been hospitalised with jaundice, dysentery, typhoid and various other afflictions, which the doctors here very comfortingly say” don’t worry, its very common in your area”. Untill next time, pray for us!!!