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Saturday, December 28, 2013

Clairvoyance 2013… a vision within and beyond

The two-day annual health event of the School of Health Systems Studies (SHSS) at TISS last week, renewed its commitment towards health care in India. With a theme of Re-imagining health and health care in India, the event brought together the who’s who of the field under one roof. Although the event was an amalgamation of both the private and public health aspects, as a public health professional I will present some of the public health issues that were highlighted in the weekend.
Clairvoyance was inaugurated by the country coordinator of UNAIDS, Mr. Ousamma Tawil. His inaugural speech addressed the audience with a question: was HIV (Human Immunodeficiency Virus) a problem in India? Yes. Was it being addressed? Yes, too. Were all people living with HIV being reached? Was money spent well? Umm… As he mildly put in the known fact that India may soon be the country with the largest population in the world, he emphasized that number (of HIV patients) was big. With 2.1 million people living with HIV, India has an annual incidence of 130,000. The key population is 8 percent trans-genders and 7 percent intravenous drug users among others. The way forward in primary health had to be based on AIDS prevention. So what seems to be an obstacle for India? With Men Seeking Men and Female Sex Workers being criminalized prevention in the key population and then in the general population is restricted. As though his address was some sort of prediction, last week’s High Court judgment on the criminalization of gay sex pins down the cultural behavior of the society of India towards this section. This attitude, Mr. Tawil said, will prevent the bridges that are required to bring people out of the dark and into the functionalities of social programs. Plans of inclusion and scaling up must be made.
With the number of people treated for HIV as 700,000 in 1700 centers across the country focusing on HIV treatment, India is the second largest nation after South Africa in the treatment of HIV/AIDS. Another milestone for India is its position as the generic pharmaceutical capital where it produces more than eighty percent of the anti-retro virals (ARVs) supplied to the world. With a reduction in external funding, the National Aids Control Organization (NACO) continues to support the momentum required to sustain the activities and has shown a drop of 57 percent in the incidence of HIV infection in the country. So why do issues like discrimination, stock outs and protests regarding these have to be in the way?
In continuum with a focus on the role of social determinants of health, Dr. Anurag Bhargav, Associate Professor at Himalayan Institute of Medical Sciences, brought to light a rather neglected aspect in the management of Tuberculosis (TB). Taking us back into the past when India was still ‘virgin’ soil for TB, Dr. Bhargav showed us the pathway in which TB soon had not only invaded the country but had become one of the top reasons of morbidity and mortality. The British who then occupied India and also suffered from TB, soon recovered while Indians continued to succumb to the disease and the only difference in management was pointed out to be Nutrition – the British were well nourished. He reminded us that it was Rene J. Dubos who in the early twentieth century had stated that, “TB is a social disease” (The White Plague). This condition of under-nutrition is still ignored and the Anti-tubercular pills, whether for six or twenty-four months, will be of little use if not supplemented with nutritious food for all patients who struggle to fight the disease. The only vaccine, Dr. Bhargav remarked, to fight TB is FOOD.
In the session on innovations in public health, various kinds of innovations especially those involving the community were presented. These included training and community health clinics where the community themselves were involved in the services provided, community auto rickshaws being used as emergency transport to health care and means of social marketing of condoms. Dr. Sapna Surendran, a Research Associate from Models Districts Health Project, Columbia Global Centers, gave the audience an idea of what it takes for an innovation to be expected on national level. Initial steps range from baseline studies and analysis of existing national surveys to triangulating this information with government officials and local stakeholders. Designed interventions are implemented and soon presented to the state and central level government that then considers whether this innovation can be applied at the local level. While all is not rosy during the process of approval, the implementation of the approved innovations at large scale also poses challenges.
As thought provoking topics were discussed extensively and ideas challenged, Ms. Leena Menghaney, India Coordinator, Campaign for Access to Essential Medicines, Medecins sans Frontieres (MSF) introduced to the audience the need for advocating for cheaper drugs. With extensive efforts MSF has been able to bring down the market price of a HIV drug from US$ 10,000 per patient per year (ppy) to just under US$100 ppy. The crunch of the issue lies in the fact that if pharmaceutical companies continue to have their way, applying for patency in every incremental change in the drug molecule, causing a monopolization in the market with the ever-greening of the drug. In that scenario, even large organisations like MSF will not be able to afford drugs for all those who require it in their projects around the world. This simply stands in no comparison then to the plight of the individual who will have no choice but to give up. While we may say HIV will not affect me, this concept is true for drugs used for management of cancers, hepatitis and many other common diseases that challenge public health today.
From an appeal of change in behavior towards those marginalized in HIV, to a call to simply feed those with TB. From the need of bringing creativity into community health programs to advocating for affordable drugs worldwide. Such were the issues that stirred up the group of budding health professionals at TISS last weekend.

By- Dr. Carolyn Kavita Tauro
MPH-Social Epidemiology
2012-2014 Batch
TISS, Mumbai

A Critical Insight into India’s New Drug Pricing Policy

Healthcare costs in India are escalating every day becoming unaffordable for the common man. It was found that drugs contribute to 70% of the out of pocket expenditure for healthcare in India. Several factors contribute to the escalating costs of the drugs absence of proper price regulation in the country being the greatest of all. This leads to inaccessibility of medicine by the common man. Though some states like Tamil Nadu, Kerala and Rajasthan have a proper drug procurement system in place to provide low cost medicines to people, majority still rely on the private pharmacies where the prices are not affordable. Hence, there is an urgent need to control the drug prices in the market to enhance accessibility.
Previous pricing policy – Cost Based Pricing
According to cost based pricing policy (CBP) the ceiling price of a drug was fixed based on the cost of production i.e. cost of raw materials plus cost of conversion plus the maximum allowable post manufacturing expenses (MAPE) of 100% which also includes the profit of manufacturer and various distribution costs. There were some difficulties faced under CBP which could have been avoided by prompt revision of the ceiling prices of bulk drugs.
Present pricing policy – Market Based Pricing
After several hurdles, government of India notified  the new National Pharmaceutical Pricing policy (NPPP) 2012 which is based on the concept of market based pricing. The main objective of the policy as stated in the gazette released is “….to put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines – “essential medicines” – at reasonable prices even while providing sufficient opportunity for innovation and competition to support the growth of industry, there by meeting the goals of employment and shred economic well-being for all.”
According to this, ceiling price of a drug would be determined by adopting the simple average price of all the brands having market share (on the basis of moving annual turnover) more than and equal to 1% of the total market of that medicine. Now the manufacturers would be free to fix any price below or equal to the ceiling price. This claims to reduce the prices of drugs and make the medicines available and affordable which may not be true in the practical sense.
First of all this policy could not give a proper justification for abandoning cost based pricing when retail prices of consumer goods and services are fixed on the cost of production. Policy justifies itself by saying it is very tedious process to collect data from the manufacturers and to calculate ceiling price every year on the basis of CBP. A simple and transparent mechanism can be put in place for collecting prices of bulk drug/Active Pharmaceutical Ingredient (API) from the excise department where manufacturers file their excise duty returns without resulting in any manipulations from the manufacturers.
The policy forgets to take into consideration other factors influencing the price of drugs. The unethical and illegal promotional/marketing activities are resulting in the bulging costs of the most of the drugs. The amount spent by the company on these marketing practices is borne by the consumer purchasing the medicine and making it unaffordable. Hence, there should be a proper mechanism in place to curb these unethical practices to control the cost of the drugs.
Reliability on the data collected to calculate ceiling price
In the paragraph 4 (ix) of the policy document it is said that “The ceiling price of the drug listed in the National list of essential medicines (NLEM) would be the simple average of prices as calculated on the basis of IMS data…”. To calculate ceiling price, data on the market share by brand, volume and price of the brand is required which is generated by IMS Health (a provider of information related to pharma industry) a private company which cannot be reliable. Policy also does not have any measures to check the robustness and reliability of the data generated by a private information provider. Moreover the data is not accessible in the public domain. So, how a public policy can be made by the data which is neither reliable nor accessible in the public domain. WHO also warned India over the method of obtaining drug pricing data from IMS Health. Previously, ORG-MARG (merged into IMS Health) study on “Trends in the price index of pharmaceutical formulations” was also questioned. It was also said that IMS pricing data is not reliable as it does not take account of discounts and rebates.
Moreover, in India drugs with the biggest volume of sales are often the highest priced ones. In such a situation calculating ceiling price on MBP will only result in increase in the price of the drugs and increase the profits of manufacturers making essential medicines unaffordable.
Inclusion of the drugs
There are more than 800 molecules that are being used in India. But, the policy takes into consideration 348 drugs that are listed in NLEM and leaves the rest of the medicines outside the list. Doctors influenced by the incentives given by drug manufactures also prescribe medicines which are not in the NLEM and not under price control. As there are no regulation on prescribing pattern there need to be a study done on the prescribing pattern and include those drugs which are highly prescribed. For example, salbutamol used in the treatment of bronchial asthma falls into the category. But, there are many other drugs of the same therapeutic category which are being prescribed to treat asthma are not brought into the price control.
In case of non-price controlled drugs, policy states to fix the price of such drugs in case if they increase by more than 10% in a year. Hence, it is evident that it allows the increase of price up to 10% annually. Policy also failed to provide a mechanism by which it will control the price of non-price controlled drugs.
Price control of Fixed Dose Combinations
Now-a-days one can find most of the drugs available in the market are fixed dose combination (FDCs). A doctor’s prescription also reveals the extent of usage of the FDCs by the consumer. Though very few FDCs like iron and folic acid, vitamin D and calcium are brought under price control most of the FDCs are left to the free market. There are also many irrational FDCs available in the market and which are being prescribed.
In paragraph 4 (xvii) of the policy document it is said that “…… If a manufacturer of a NLEM drug with dosages and strengths as specific in NLEM, launches a new drug by combining the NLEM drug or non NLEM drug or by changing the strength and dosages of the same NLEM drug, such manufacturers shall be required to seek price approval from the government before launching the new drug.” But, we do not know how the government is going to ensure the control and under what mechanism it will control the price of such FDCs coming into the market. Hence, there should be a strict regulation on allowing FDCs into the market to control irrational combinations and a proper mechanism should be in place to fix the price of new FDCs.
To conclude a better policy can be framed considering the loop holes of the present policy which is a market based one. When implementing a policy of huge public concern data should be collected from reliable sources. Prescription patterns should be understood to include various other formulations which are not currently under price control. There should be a mechanism in place to curb unethical marketing practices and allowing irrational FDCs to enter the market which increase the cost of medicine making it unaffordable. Hence, in a country like India where most of the healthcare expenditure is out of pocket 70% of which accounts for medicines, there should be a proper mechanism to control the price of drugs to make health care affordable.
By- Pavan Kumar Allani
MHA-Health Administration
2012-2014 Batch
TISS, Mumbai