While market based pricing can potentially reduce rates for two-third essential medicines, there are far too many loopholes in the move. Pharma companies have exploited such escape routes in the past
According to the Drug Prices Control Order (DPCO), 2013 the ceiling price of essential medicines is fixed based on the simple average of the prices of all brands of that drug that have a market share of at least 1%. The national list of essential medicines lists 348 bulk drugs, which are sold as 650 formulations. The DPCO itself covers only 14 %-17% of the Rs75,000 crore pharma market, which means only a small subset of the market will be impacted. The good news is that for two-third essential medicines, there can be average price reduction of 22% (even though some reports claim reduction by 30%-40%). The bad news is that there are far too many loopholes to really see reduction in your chemist bill.
According to Dr Chandra M Gulhati, editor, Monthly Index of Medical Specialities (MIMS), “Major lacuna with DPCO 2013 are (a) Fixed Dose Combinations (FDCs) out of price control, (b) increase of roughly 10% on 1st April year after year, (c) patented drugs not covered which will lead to domestic manufacturers suffering and MNCs benefitting. There are about 900 total medicines. The price regulation will cover 348 drugs. There will be lots of opportunity to shift from regulated to unregulated drugs. Combinations of two drugs (within 348) will be out of price control. An estimated half of all dosage forms will be out of price control on this account. The policy and its instrument, the DPCO 2013, are shockingly silent on these escape routes.”
According to S Srinivasan, managing trustee, LOCOST (Low Cost Standard Therapeutics), “Experience shows that manufacturers producing medicines under price control, in this case the drugs in National List of Essential Medicines (NLEM) 2011, are likely to stop making them and migrate to other medicines of the same chemical class as these other equivalent drugs are not in the NLEM 2011 and therefore, out of the purview of DPCO 2013. The other route to escape price control is by making a FDC of the drug under price control, or, by manufacturing non-standard strengths of the same drug (like 650 mg instead of 500 mg paracetamol). Since these strengths are not mentioned in the scheduled list of DPCO 2013, they will not fall under the price control radar.”
Dr Gulhati, says, “Since ordinary customers do not understand drugs and their composition and combinations, it is a breeding ground for unethical practices and mis-selling by pharma manufacturers. There are many ways in which this happens. Companies evade the price ceiling by the simple trick of adding or changing one or more ingredients in a price-controlled drug.”
Some of the examples of such manipulation, already done in the past, are as follows - Aciloc-RD of J Chemicals (where the price-controlled ranitidine was replaced with omeprazole); Cetrizet-D of Sun Pharmaceutical (price-controlled pseudoephedrine replaced with phenylepherine), Normet of Emcure (price-controlled norfloxacin replaced with ofloxacin) and Brakke Suspension of Franco-Indian Pharmaceuticals (price-controlled ciprofloxacin replaced with ofloxacin). The brand name was never changed in the above-mentioned cases.
Mr Srinivasan, says, “The remedy to prevent such ‘migration’ is to put all chemical analogues (the ‘me-toos’ and/or iso-mers) of the medicines included in NLEM under price ceiling. Thus not only enal-april but all other angio-converting-enzyme (ACE) inhibitors, not only ator-vastatin but all other statins, most if not all anti-diabetics, et al, would need to be under price ceiling. Otherwise the purpose of the DPCO 2013 stands defeated.”
All India Drug Action Network and other NGOs want all combination drugs, patented drugs, life saving drugs and molecules in the same therapeutic class under price control.
Para 32 of the DPCO 2013 lists cases eligible for exemption from price regulation for five years: drugs that have a product/process patent in India and “new drugs” as per Rule 122E of the Drugs and Cosmetics Rules, 1945 with the proviso that such drugs be developed through indigenous research and development (R&D).
According to Mr Srinivasan, “This clause, apparently good intentioned, is likely to boomerang for the following reasons - It is doubtful whether many of the pharma-related patents, awarded post-2005, really deserve their patents. The frequency of frivolous plus undeserved patents may increase because the related medicines would be exempt from price regulation. The other provision for exemption for new indications and new dosages and new delivery systems (under Rule 122E) would only increase frivolous claims for new indications/new non-standard dosages and/or result in existing simple tablets, for example, being put unnecessarily in a sustained release form – which will then be a “new drug” under 122E and therefore price control exempt. Hence, there is a need to have a good system to assess such claims by manufacturers.”
In the third part of the article, we will look at the grey areas about what constitutes “essential drugs” and “unessential drugs”.
Whether cancer therapy has brought down the death rate is a question waiting for an answer
I always used to feel that our treatment of cancer does not fit in with common sense. But when I said so, I was mocked. When Nobel Laureate biologist, Albert Szent-Györgyi, noted that it would be difficult to kill cancer cells to the exclusion of surrounding normal cells, since normal and cancer cells work alike, his colleagues went to town with the criticism that this “once brilliant biologist has now gone crazy.”
Now comes a bombshell in the most ‘prestigious’ science journal of the UK, Nature, which has published the results of a study done in Oxford that has shown that, for certain cancers, chemotherapy, in fact, helps the cancer cells to grow which kills the patient!
The abstract of the paper reads: “Acquired resistance to anticancer treatments is a substantial barrier to reducing the morbidity and mortality that is attributable to malignant tumours. Components of tissue microenvironments are recognized to profoundly influence cellular phenotypes, including susceptibilities to toxic insults.
“Using a genome-wide analysis of transcriptional responses to genotoxic stress induced by cancer therapeutics, we identified a spectrum of secreted proteins derived from the tumour microenvironment that includes the Wnt family member wingless-type MMTV integration site family member 16B (WNT16B)...The expression of WNT16B in the prostate tumour microenvironment attenuated the effects of cytotoxic chemotherapy in vivo, promoting tumour cell survival and disease progression. These results delineate a mechanism by which genotoxic therapies given in a cyclical manner can enhance subsequent treatment resistance through cell non-autonomous effects that are contributed by the tumour microenvironment.”
Even suspicious cells make for a definitive diagnosis and the three-pronged attack on the hapless patient has now been shown to be counterproductive by this study. The triple attack has many drawbacks. Extensive mutilation, viz., radical surgical attempts, has its own inherent mortality in the elderly which, at times, become unacceptable.
The side-effects of chemotherapy and the fallout of radiation are all there for anyone to see and learn from. We should find methods to avoid making our treatment worse than the patient’s disease. Whether cancer therapy has brought down the death rate and disability is a million dollar question waiting for an answer, especially after trillions of dollars worth of income to the establishments, medical and pharmaceutical. The initiative by Dr Harold Varmus, of American Cancer Institute, set up a committee of nine specialists to look into the very definition of cancer, from the present all-encompassing definition, to help the industry.
In an article some time ago, I had gone into great details about
Dr Varmus’s plan to rename cancers. At present, more than 70% of the diagnosed cancers are, in fact, not cancers at all. They do not go to become killer cancers and most of them outlive humans. Of course, there are NO pre-cancerous conditions.
There are many natural cancer relief methods that have been suppressed and condemned by the mainstream establishments. One among them, which has been studied extensively recently, is the Indian spice: turmeric.
Turmeric has been shown to be very effective in cutting off blood supply to the tumour mass. Used in early stages, it might completely suppress cancer growth. Turmeric has also been shown to minimise the chemotherapy side-effects to make life easier for victims.
There are a host of others waiting to be investigated scientifically to see if they are good without serious side-effects like those of the chemotherapeutics. There is a crying need for such research but who will fund such research since it might threaten to break mainstream drug cartel’s rice bowl? Our sole aim should be to cure rarely, comfort mostly but to console always as believed by Hippocrates. We should strive to make the patient’s life bearable through a better and simpler approach to cancer therapy.
Professor Dr BM Hegde, a Padma Bhushan awardee in 2010, is an MD, PhD, FRCP (London, Edinburgh, Glasgow & Dublin), FACC and FAMS.