Leisure, Lifestyle & Wellness
Medicine prices: DPCO loopholes will deny cheaper essential drugs–Part2

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.

 

Read Medicine prices: Encouraging profiteering from essential drugs
 

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”.

 

Read-
Drug Abuse
 

Will you really get cheaper medicines?
 

New drug pricing policy may increase prices of essential medicines

User

COMMENTS

Dhaval Hathiwala

3 years ago

@madhav deshpande; Mr. madhav deshpande, do you really know what are the principles of "Pharmacoeconomics"? You were talking about Price fixation based on pharmacoeconomics principles, and of course, it is mentioned in DPCO,2013; but actually in order to follow pharmacoeconomics principles, our country need to have our country specific GUIDELINES FOR PHARMACOECONOMICS, which doesn't exist at all, and I am confident enough that you would be totally unaware about the situation. Go to the website http://www.ispor.org, learn something from this website, what actually means - Pharmacoeconomics. Till date, 33 counties have their own country specific GUIDELINES FOR PHARMACOECONOMICS, but the problem is that people in India, including you Madhav Deshpande, don't know even about simple basics of PHARMACOECONOMICS, this creates chaos while debating on national issue. Without reaching the roots of matter, we will start commenting on such sensitive issues. Learn, understand, analyze the information you got around, Mr. Deshpande.

madhav deshpande

3 years ago

this is further to my posting pint 15 in DPCO order is as follows
15. Fixation of retail price of a new drug for existing manufacturers of scheduled formulations.– (1) The Government shall form a Standing Committee of such Experts, as it may deem fit, within sixty days of notification of this order with a view to recommend the retail prices of new drugs on the principles of “Pharmacoeconomics”.
(2) Where an existing manufacturer of a drug with dosages and strengths as specified in National List of Essential Medicines launches a new drug, such existing manufacturers shall apply for prior price approval of such new drug from the Government in Form-I specified under Schedule-II of this Order.
(3) On receipt of the application under sub-paragraph (2), in the event of the new drug available in domestic market, the Government shall fix the retail price of the new drug in accordance with the provision of sub-paragraph(1) of paragraph 5 and in the event of the new drug not available in domestic market, the Government shall forward the same to the Standing Committee of Experts who shall examine the application on the principles of “Pharmacoeconomics” and make recommendations of retail price of the new drug to the Government within thirty days of the receipt of application.
(4) The Government shall, on receipt of recommendation under sub-paragraph (3), within thirty days, fix the retail price of such new drug and such price shall be applicable to such applicant of such new drug.

madhav deshpande eutherva

madhav deshpande

3 years ago

This is true in the past people have done change of molecule.But in the new DPCO there is term "New product" and as it says any one who launches the new product in the form of combinations from above listed DPCO molecule ,they need to take price approval before launch
(u) “new drug” for the purposes of this Order shall mean a formulation launched by an existing manufacturer of a drug of specified dosages and strengths as listed in the National List of Essential
Medicines by combining the drug with another drug either listed or not listed in the National List of Essential Medicines or a formulation launched by changing the strength or dosages or both of the same drug of specified dosages and strengths as listed in the National List of Essential Medicines
2) (i) the price to retailer of a new drug, not available in domestic market, shall be fixed by the Government on the principles of
Further the order says
“Pharmacoeconomics” of the new drug, on the recommendation of a Standing Committee of Experts formed under paragraph 15.
(ii) the retail price of such new drug shall be fixed by adding sixteen percent margin to retailer on the price to retailer as fixed in item (i):
if our understanding is wong we request expert to comment on above
Madhav deshpande
director
eutherva medicament pvt ltd

MOHAN SIROYA

3 years ago

I fully agree with the logical analysis of Raj Pradhan.

All the policies made by the 'Interested bureaucrats, made and Government enacted in laws, it was solely with a purpose to leave loopholes, thru' which politicians and the entire Corrupt Government system will reap benefits and allow the bulging pockets of Industrialists and Manufacturers to fatten up more at the cost of gravely neglected CONSUMER public. The system breeds all such ills.

REPLY

raj

In Reply to MOHAN SIROYA 3 years ago

thanks

raj

In Reply to MOHAN SIROYA 3 years ago

thanks

Rajhans

3 years ago

At retail point before last price reduction from DPCO we were getting 10% discounts on all drugs on mrp but after dpco order chemist stopped this discount which was availed since long time.So in the end patient is the looser.Whatever this DPCO does but the real benefit will never come in hand of users.All this announcement are just eye wash instead prices of many drugs are increasing.

REPLY

MOHAN SIROYA

In Reply to Rajhans 3 years ago

Increasing? It has already increased. For instance an essential Urine flow drug( Prostrate patients)like Hittrin , Urimax D etc. now costs almost 25 percent extra in MRP than it used to be 6 months ago. Except generic vitamin B , daily use multi diatary vitamin tablets like Neurobion or Macraberin Forte or Asprin tabs are maintiaing price line because they under 'Controlled" category.
All other drugs MRP has increased.
I used to spend about Rs.1000 p.m. now the same drugs cost me about 1200-1250 p.m.

raj

In Reply to Rajhans 3 years ago

which chemists have stopped giving discount? which drugs have increased prices? you can write to rajpradhan@moneylife.in

madhav deshpande

In Reply to Rajhans 3 years ago

dear rajhans
you may pl recheck with chemist most of the companies have given the discounts as per old systems so there is no reason why tour chem now can reduced you 10%
madhav deshpande

Cancer Balloon Punctured!

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.

User

COMMENTS

hasmukh

3 years ago

Cancer treatment, expertise in this field etc. appears to be a big racket. About more than 30 years ago, I remember having read a series of articles in magazines by Dr. Manu Kothari and Dr. Lopa Mehta saying the similar thing.
These drug makers and experts ought to be sympathetic to cancer patients and give honest advice and not "loot" them.

Campa Cola Case: Supreme Court stays demolition till 31st May

The Supreme Court that had ordered the demolition of illegal floors of seven buildings in Campa Cola Compound stayed its order till 31st May
 

After taking suo moto notice, the Supreme Court on Wednesday stayed the demolition of illegal floors of buildings in Campa Cola Compound till 31 May 2014.

 

Earlier today, the BrihanMumbai Municipal Corporation's (BMC) that was stopped from initiating action, demolished the main gate of the society which was blocked by residents, with the help of bulldozers. Police entered into the compound and evicted the protestors forcibly.

 

A bench headed by Justice GS Singhvi took suo moto cognizance of media reports and stayed the demolition process.

"It is not merely a legal issue, but a human problem," the bench observed. "We were badly disturbed by the events reported by the media last evening. From 11.30 to 3.30am we were disturbed."

According to the broad outlines submitted by attorney general GE Vahanvati before a bench out of nine structures originally proposed in the complex, only seven have been built, leaving enough floor space index (FSI) for accommodating the present members of the housing society.

Thus space is available for raising a new building. Those who are going to lose their accommodation may be put up in the new structure. The rules regarding FSI have also changed, which would allow the housing of all affected residents, Vahanvati said.

The bench noted the proposal of the attorney general and granted him time till next Tuesday to put his proposal in writing. They also asked counsel for the residents, FS Nariman and Mukul Rohtagi, to find out whether the proposal would be acceptable to them. The court observed that the suggestion seemed to be reasonable.
 

Yesterday, Campa Cola Society in Worli area of Mumbai witnessed tense moments as over 100 families barricaded themselves and refused to move out of the compound. However, BMC, the civic body, initiated action to disconnect power, water and gas connections before going in for demolition of illegal floors as per the orders from the Supreme Court.

 

Milind Deora, minister of state for communications & IT and shipping, told reporters that the BMC has confirmed that they have received stay from SC on demolition till 31 May 2014.

 

The apex court had set the 11th November deadline to vacate 102 flats declared as illegal. Families living in the compound had pinned their hopes on chief minister (CM) Prithviraj Chavan stepping in and saving their homes by passing an ordinance to regularise their flats. However, the CM reportedly does not want to go against the legal opinion of the advocate general.

 

The apartments in the Campa Cola Compound were constructed on land leased in 1955 to Pure Drinks Ltd. Pure Drinks was later allowed by the BMC in 1980 to build residential apartments. Seven high-rise buildings were constructed at the compound between 1981 and 1989 by developers Yusuf Patel, PSB Constructions and BK Gupta.

 

Illegal floors of Midtown Apartments, Esha Ekta Apartments, Shubh Apartments, Patel Apartments (two buildings, six floors each), BY Apartments and Orchid Apartments comprise 140 flats. While the builders were granted permission for ground-plus-five floors, Midtown has 20 floors, Orchid has 17, Esha Ekta has eight, Shubh has seven, while BY and Patel have six floors each.

User

COMMENTS

Vaibhav Dhoka

3 years ago

Knowing well the illegal status of flats by flat owners and now demanding immunity from demolition shows which way we are going and how well the judicial orders can overruled or overturned,this is reason why people have loosing hopes in justice system.

shadi katyal

3 years ago

One should question SC that how such action was changed and thus created a precedent for other such illegal buildings.
Is it not common in our nation to violate all orders and do what we can do and when questions are raised we can buy the Law. Is it not what happened here. After all these flats did not just grew over night. Did people wsho bought these do any investigation? Yes one feels sorry for the families but some one has to suffer if we wish to change our society. Human factor is always involved in all facets of life.
The corruption is so rampant that one can get away.
Does anyone know hat happened to ADARSH BHAVAN???

chandan sinha

3 years ago

Thanks to those behind stopping this demolition by BMC. Now BMC should find those builders who constructed higher floors without approvals and make an example for small and big builders not just across MMR but also in whole of India...

REPLY

Vaidya Dattatraya Vasudeo

In Reply to chandan sinha 3 years ago

A day-dream. This will never happen because it has never happened. BMC has yet to demolish other half-a-dozen or more buildings for which orders have been issued.

The buyers, since 1991 if not since 1984, were fully aware of illegality of the construction and had obtained a massive discount of more than 20%. It is admitted by an occupant on the TV. It is a fraud to start with.

It is like getting illegal admission to a college and in the month of March, when Universities refuse the forms, the parents go to court, seek mercy in the name of humanity and enjoy. All this predicted while taking admission illegally. It stopped ( probably ) only when one judge refused to accept this mercy.

Government must demolish these extra construction, and give all the administrative help to occupants to file case against builders, whether live or dead.

I wonder with all this hangama why the Court has never ordered immediate action against the concerned officers. The moment these officers are caught, they will give lot of interesting stories about who are all involved in this.

If it is not demolished, not a single illegal construction can be demolished in future. In the process law breakers enjoy and get more benefits and law abiding citizens have to suffer keeping with the law. When will it change. Who will change it.

chandan sinha

In Reply to Vaidya Dattatraya Vasudeo 3 years ago

It took 30-35 years for BMC to come to a conclusion of demolishing the floors above. That's more than a generation.Builders are equally involved if not more. What was BMC doing waiting for construction to complete and flats to be sold scrupulously and then tk action?

Btw, it's nt a day dream, am 30 sth and this is not 80s. Things r moving v fast now. Changes r fast. I believe Govt processes will c a mojor revamp soon in future and will live to see it. I am already part of it.

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