Tuesday, 22 December 2015


Thursday, 15 January 2015

The need to take up 'free medicine programme' 7 Nov 2014, Deccan Herald


The need to take up 'free medicine programme'

Dr Gopal Dabade, Nov 7, 2014:
DH illustration- for representation

Providing healthcare is the responsibility of the state. As a part of providing healthcare, few states like Tamil Nadu, Kerala and Rajasthan have initiated the ‘free medicine programme’. It is time to examine the condition of free medicines in other states too.
Making medicines available free in government health centres is important. It prevents people from sinking into debt, improves the quality of life and increases longevity. 

Several reports of the Planning Commission (2011 and 2012) have stressed the need to move towards ensuring free essential medicines, as otherwise, ‘Out-Of-Pocket Expenditure (OOPE)’  on healthcare will be a major cause for economic catastrophes in the families. The number of families that are reduced to penury by the cost of healthcare is shocking. In 2011, nearly 60 million people were impoverished due to high OOPE on healthcare. Of these, nearly 70 per cent of the cases were due to the expenditure on medicines. 

The non-availability of free drugs has resulted in low utility of the government health services in India. Increasing the access to free essential medicines will reduce the OOPE burden for the populations and thereby increase the financial protection for the household expenditures. The credibility of public health systems and utilisation by the needy people will depend on the availability of free medicines. In Tamil Nadu, after the introduction of an efficient drug procurement and distribution system to ensure availability of free essential medicines, saw the total number of people accessing public health facilities go up from 20 to 40 per cent.
It is in response to OOPE that states like Tamil Nadu and others have already initiated a free medicine policy which is a great boon for the people. Curiosity makes one wonder as to what is the policy on free medicines in Karnataka. According to the Karnataka government, there is a free medicine policy in place but not ‘really’ implemented in spirit. A recent study in August 2013  by WHO, titled “Karnataka, India Pharmaceuticals in Health Care Delivery,” which has specifically examined in detail the availability (or to be more precise, the non-availability) of free medicines at government health centres across the state throws light on this important public health issue.

The report highlights that stock-out of medicines is a huge problem in many health centres. It reports that “stock-out status of the Karnataka Drug Logistics and Warehousing Society (KDLWS) revealed a significant number of stock-outs on that day. Overall, 24 per cent of items were out of stock in 80 per cent or more of the warehouses and only 23 per cent of items were available in all warehouses. A number of community members and other stakeholders stated that stock-outs were a problem”.
The studies and reports say the state government has set up few ‘Generic Medicines Outlets’ which are mostly situated in the very buildings of government health centres where medicines are sold at an affordable price and are not free. If the ‘free medicine programme’, was in place like it is being falsely claimed by Karnataka health authorities, then one wonders as to why medicines are being sold! It is indeed a huge, unexplainable paradox!      

The non-availability of medicines is being constantly denied by most top level bureaucrats and also the politicians who are at the helm of this. This seems to be a perfect example of an ostrich-like attitude.

Why this shortage?

The Karnataka State Drugs Logistics and Warehousing Society (KDLWS) was planned on the lines of Tamil Nadu Medical Science Centre (TNMSC). But it differs from TNMSC because of the lack of staff in general and the lack of regular staff dedicated specifically to the KDLWS. The two warehouses visited were piled high to the ceiling with drugs and there was lack of information on stock levels at facilities. 
Were the KDLWS to be a medical services corporation, it would have greater autonomy to hire staff.” mentions the WHO report. In addition to a shortage of staff, standard methods for quantification and common electronic management information system (MIS) operating at district warehouses and facilities are unlikely along with the late procurement process such stock-outs.

At the outset, the bureaucrats and the ministers responsible for implementing the free medicine programme for Karnataka will need to accept the fact that the  programme is not in place and that there needs to be changes brought in both, systematically and scientifically. Changing the mindset will be the achievement of the first major milestone coupled with the political will to achieve the same.

The WHO document has suggested several important guidelines. Currently, there are no mechanisms that will truly reflect the medicine requirements at the health centres and so drugs are distributed not on need basis but just on ad hoc. So, the KDLWS needs to produce annual report on consumption comparison of medicines at every district level. 
There is an urgent need to bring in transparency in procuring medicines and this should be based strongly on the WHO concept of Essential Drug List (EDL). This list needs to be published in the form of a booklet and distributed to all health facilities and medical colleges. Medical doctors and specifically those in government service at every level need to be sensitised by providing them with pre-service and in-service ongoing training about the use of EDL. A high level committee should monitor that the concept of EDL is in place at every level. 

There is a need to obtain a feedback from the exiting patient and interview them to see the number of outside prescriptions that are given. All medical college hospitals should develop evidence-based formulary lists. There is a way forward but all it needs is a political will to serve the needy!

(The writer is president, Drug Action Forum – Karnataka)

India-US panel; Access to medicines may be under threat, 29 Dec 14, DH


India-US panel: Access to medicines may be under threat

Dr Gopal Dabade: Dec 29, 2014:
India-US panel: Access to medicines may be under threat

Medicines when used appropriately can save lives. Unfortunately, huge populations of people globally do not have access to essential medicines. It is rather interesting to note that the type of patent laws of a country can completely change the access to essential medicines scene. 

Which squarely means that the patent policies of a country can either be ‘people friendly’ or in other extreme and worst situations, serve the profit interests of the huge multinational drug companies. 
If the patent laws of any country are not favouring big drug companies, then it is also no surprise that these laws face continuous threat from the big pharma. This in turn will affect the lives of millions in developing countries. The United States is using different tactics to increase its pressure on India to revise its patent system.

Indian patent laws have safeguards that make the price of medicines affordable. It is precisely these laws that have nourished the robust Indian generic drug companies, which slash the prices of medicines and has made India an important supplier of low-priced medicines to treat diseases such as TB, malaria, cancers, diabetes and cardiovascular disease. 

In the case of medicines much needed for HIV/AIDS the prices have been slashed by 90 per cent. HIV/AIDS has been a major public health problem in several poor setting countries and when Indian generic drug companies produced medicines at such affordable prices that they became the darling of the poor countries. 

No wonder that Indian drug manufacturing companies are considered as “The Pharmacy of Developing Countries”, as they supply medicines at affordable prices to around 200 developing countries all over the world.

The US, which houses most of the big multinational drug companies, wants to bring pressure on the Indian government to amend the Indian Patent Act as it is becoming a hurdle in their profit making business. 

Several incidents in the recent past are an indication that the Indian government may be bending down to accommodate to the needs of the US drug companies.

The Indian prime minister’s visit to the US was a big news all over the world. But, unfortunately, it was at this visit that the US and India announced the formation of a US-India high-level Working Group on Intellectual Property. 

This group will have the authority to give directions that can make changes in the Indian Patent Act. This, in turn, will affect the lives of millions in developing countries. The US is using different tactics to increase its pressure on India to reform its IP system.

Within days of Prime Minister Narendra Modi’s visit to the US, the United States Trade Representative (USTR) launched an ‘Out of Cycle Review’ of India’s patent regime that carefully targets the areas that displease US businesses without any regard to global health.

Apart from all this, the US government has set up the ‘United States International Trade Commission’ (USITC) which is an independent, quasi-judicial federal agency with broad investigative responsibilities on matters of trade with a concern for its industry. 

The USITC held hearings in the US as its drug industry associations made false allegations that India had failed to comply with its obligation under the Trade-Related Intellectual Property Rights (TRIPS) agreement. The USITC launched a second investigation in October 2014, even before the report of the first investigation had been released, in order to intensify pressure on the Indian government.

According to a recent report by USITC titled “Trade, Investment, and Industrial Policies in India: Effects on the US Economy” of December 2014, the Indian “intellectual property policies, have large negative effects on (its) specific industries”. The USITC’s press release directly refers to the demand of standards of patent laws protection comparable to USA and Western European levels.

Compulsory licensing

Two major contentious issues that are expressed in the report include the provision of Section 3(d) and granting of compulsory licensing, both of which are important part of the Indian Patent Act. Section 3(d) is to prevent the practice of patent “ever greening,” which reportedly occurs when a manufacturer makes minor improvements to an existing patented medicine and tries to obtain a new patent. 

Compulsory licensing is on the other hand allowing someone else to produce a patented product without the consent of the patent owner on grounds of public health emergency.

The US industry representatives, particularly those in the pharmaceutical and biotechnology sectors, consider patent barriers a substantial obstacle to doing business in India. 

According to the USITC report, “US industry representatives also are concerned about the “contagion” effects on other countries of section 3(d) and compulsory license provisions in India’s law.” That is, they are worried that other countries will follow India’s lead and promulgate patent policies that undermine core business models based on incremental innovation. 

For example, in 2008, the Philippines amended its patent law to add language similar to section 3(d) to describe inventions that would not be patentable. In 2012, Argentina issued resolutions that limit  patentability of derivatives of pharmaceutical products much the same way as India.

It is indeed good that India is showing the way to other developing countries with regard to framing patent laws. If Indian government succumbs to these pressure tactics then the pharmacy of developing countries will dry up and millions of patients in around 200 countries will have to face suffering and death due to lack of essential medicines.

(The writer is President, Drug Action Forum – Karnataka)

Monday, 6 October 2014


An insight
Drug Action Forum – Karnataka (DAF-K) is a registered, not for profit, independent non-government organisation (NGO) that is campaigning for Rational Drug Use and Policy.
Drug Action Forum - Karnataka advocates health and access to life saving and essential medicines as a basic human right as envisioned in the Alma Ata Declaration of WHO (http://www.searo.who.int/LinkFiles/Health_Systems_declaration_almaata.pdf) of which India is a signatory and further endorses the “People's Health Charter” (http://www.phmovement.org/en/resources/charters/peopleshealth of People's Health Movement (http://www.phmovement.org/).

Drug Action Forum – Karnataka (DAF-K) is part of All India Drug Action Network (AIDAN - http://aidanindia.wordpress.com/), Health Action International AsiaPacific (HAI-AP http://www.haiasiapacific.org/) and People’s Health Movement – India (PHM-India - http://www.phmovement.org/india/).  DAF-K member is also part of Health Action International – Europe (http://haieurope.org/ HAI-E). It is through these networks that DAF-K brings forth local issues to various national and international bodies.
DAF-K grew out of a felt need as many rural community programme lead by doctors from different regions of Karnataka felt that the cost and use of medicines was forcing several families to penury and that this needs to be focused both nationally and internationally. Though initially it consisted of only few doctors later on it grew as the necessity was felt to involve others like journalists, advocates and other campaign groups, which were like-minded.

Various programs initiated
by Drug Action Forum - Karnataka: -

a) Globally Dr Olle Hanson’s Day, 24th May is commemorated as anti-hazardous drug day. By arranging lectures, publishing and releasing books and poster exhibition and press coverage on this particular day Drug Action Forum-Karnataka, highlighted the situation in India to public.

b) Drug Action Forum-Karnataka approached High Court, Karnataka, India for sale of banned drugs in 1987. Again in 1994 Drug Action Forum-Karnataka along with AIDAN and NCCDP (National Campaign Committee on Drug Policy, New Delhi) filed a writ petition in Supreme Court, New Delhi. The court case dealt with various irrational drug combinations that exist in India and was historical case in the sense that it witnessed several hazardous drugs out of the market. This was a breakthrough among activists working in India in the field of health and rational drugs.

c) Currently along with SAMA and LOCOST, Drug Action Forum – Karnataka is also part of a case in Supreme Court of India with regard to the clinical trials of HPV vaccine.

d) Drug Action Forum – Karnataka has to its credit of launching the “Novartis Boycott” campaign. This was when Novartis challenged the rejection of grant for its anti-cancer drug (Gleevac - Imatinib mesylate). Along with this it also challenged Section 3d of the Indian Patent Act. At first Novartis approached the Chennai High Court and then subsequently the Supreme Court of India, New - Delhi. In this long drawn legal battle Novartis lost both the cases. Throughout the case Drug Action Forum – Karnataka launched a campaign against Novartis – calling upon the medical profession all over the country and also the lay public to boycott purchase of any of the products of Novartis; thus creating awareness. The campaign became popular by its name “Novartis Boycott”. This campaign picked up and was supported by AIDAN and People’s Health Movement – India. This particular issue got international media attention. After the Supreme Court judgment the boycott campaign was withdrawn.

e) Drug Action Forum – Karnataka has done a study to address the huge problem of irrational drugs in the Indian market, with a focus on drugs to treat nutritional anemia – a very common clinical condition in India. The study titled “No Drugs to Treat Anemia” focuses on as to how the drug industry has not evinced any interest in manufacturing rational medicines to treat anemia and on the other hand the market is flooded with several costly and irrational products. This study received national media coverage.

f) Vaccines are an important public health tools and one need to address the vaccines needs based on epidemiological studies but unfortunately the vaccine industry along with the support from United Nations bodies (especially WHO) is trying to push several vaccines that are questionable into national vaccine programme of India. DAF-K expresses its concern about the decision making process within WHO; as more and more multinational companies have started being stake holding in WHO. All this is reflected by initiatives of developing countries like India where a host of vaccines are being pushed into public health and thus exhausting the scarce public health resources. DAF-K had specifically examined the issue of hepatitis – B vaccination national programme and made recommendations’ as to how the vaccine can be used judiciously and rationally.

g) DAF-K has launched the “FREE MEDICINES CAMPAIGN”. Accordingly free medicines to be made available in all its government hospitals for the state of Karnataka. This is on the model of Tamil Nadu Medical Service Corporation (http://www.tnmsc.com/). Several Trade Unions have been contacted and training imparted to them on this important issue. (Please see photo). Soon a state level campaign will be launched.