#India – Govt has no plans for National Health Bill #WTFnews


PIB RElease, March 22, 2013

The Government has no plans to introduce National Health Bill. In order to
provide relief to the common man in the area of healthcare, a countrywide
campaign in the name of “Jan Aushadhi Campaign” has been initiated by the
Department of Pharmaceuticals, in collaboration with the State Governments,
by way of opening up of Jan Aushadhi Generic Stores in the Government
Hosptials to supply of generic medicines through Central Pharma Public
Sector Undertakings, to make available quality generic medicines at
affordable prices to all. So far, 149 Jan Aushadhi Stores have been opened
in different States/UTs in the country as on 28.02.2013.

Further, under the provisions of the Drugs (Prices & Control) Order, 1995
(DPCO, 1995), the prices of 74 bulk drugs listed in its First Schedule and
the formulations containing any of these scheduled drugs are controlled.
National Pharmaceutical Pricing Authority (NPPA) fixes or revises prices of
scheduled drugs/formulations as per the provisions of the DPCO, 1995. In
respect of drugs not covered under DPCO, 1995 i.e. non-scheduled drugs,
manufacturers fix the prices by themselves without seeking the approval of
the Government/NPPA. However, the trend in prices of non-scheduled drugs is
monitored and suitable action is taken by NPPA where price increase is more
than 10% in a period of one year on moving basis.

The National Pharmaceutical Pricing Policy -2012 (NPPP-2012) notified on
07.12.2012 provides all the manufacturers/importers manufacturing /
importing the medicines as specified under National List of Essential
Medicines 2011(NLEM-2011) shall be under the purview of price control. The
objective of NPPP-2012 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.

The Government is also providing support to the States under the NRHM for
providing free Generic Drugs in Public health facilities. States have been
encouraged to bring out essentials Drugs lists (EDL) facility wise and
Standard Treatment Guidelines to promote safe and efficacious drug use.

This information was given by Minister of State for Health & Family Welfare
Shri AbuHasem Khan Choudhuryin written reply to a question in the LokSabha
today.

 

#India- How Pharma Giants Use Litigation To Evade Fines


Big companies overprice medicines and often get away with it by resorting to longwinding court cases
Shonali Ghosal

SHONALI GHOSAL

2013-03-30 , Issue 13 Volume 10

Unaffordable? Pharma companies are yet to pay 90 percent of the fines for overpricing drugs, Photo: AFP

Pharma companies have been fleecing the consumers by overpricing their medicines. As of 31 January, the total amount overcharged by companies stands at a mind-boggling Rs 2,596 crore, according to the National Pharmaceutical Pricing Authority (NPPA). This figure is for the period since 1997 when the regulatory body was set up. On the other hand, the amount recovered by the NPPA stands at a measly Rs 234 crore — just 9 percent of the total.

Cipla tops the list of defaulting companies and owes the regulator fines amounting to Rs 1,684 crore. According to the list of erring companies and the recoveries made from them (available on the NPPA website), the pharma giant figures in 16 different instances of overpricing . Despite sending out demand notices, the regulatory body has failed to get Cipla to pay up even in a single instance.

The second major defaulter is Ranbaxy, which has already paid Rs 30 crore in fines, but still has dues pending of Rs 105 crore.

Under the Drugs (Prices Control) Order (DPCO) of 1995, the NPPA is empowered to regulate prices of medicines that use 74 out of the 500 commonly used bulk drugs (active pharmaceutical ingredients in medicines). These 74 drugs are mentioned in the  National List of Essential Medicines of India. When companies overprice these drugs, the NPPA can recover the overcharged amount in addition to an annual interest of approximately 15 percent as per the Essential Commodities Act.

However, once the company challenges the decisions in court, the case drags on as the DPCO does not allow for out-of- court settlements. One contention commonly raised by companies is that the composition of the medicine they produce and market is different from what is mentioned in the notification.

Companies also argue that they are a small-scale industry and therefore exempt from regulation, or that the stipulated price for the composition was not known at the time they introduced the medicine in the market.

As a result, more than 90 percent of the pending fines remain unpaid and locked up in lengthy litigation.

Though most other companies have either paid or have started paying their fines, Cipla has at least three cases stuck in various high courts and the Supreme Court. Consequently, the penalty for overcharging keeps rising every year with the annual interest adding up. Sources say the Supreme Court has asked for all of Cipla’s cases to be sent to it so they may be disposed together.

Some like Delhi-based RTI activist Afroz Alam Sahil raise questions about the efficacy of the NPPA itself. In response to an RTI petition filed by him last year, the NPPA said it does not have a compiled list of drugs and pharmaceutical companies, and asked him to look up the Directory of Pharmaceuticals Manufacturing Units in India on the Internet. “How do they monitor companies they do not have a record of?” asks Sahil.

Replying to another question in the petition, the NPPA stated that the sampling that was done to check if any drugs were actually being sold at rates higher than their MRP was mostly confined to the Delhi region in 2012. “That allows companies to contest the quality of sampling as their drugs are sold all over the country,” says Sahil. “How can the NPPA care only about drugs sold in and around Delhi?”

Though the Ministry of Chemicals and Fertilisers is set to enforce a price cap on 348 ‘essential medicines’ as opposed to the existing 74 bulk drugs on the essential medicines list, this step can contribute to the reining in of drug prices only if the NPPA is able to recover fines from defaulting companies. Currently, about 1,000 formulations that include the 74 essential bulk drugs are under price control.

Along with the proposed expansion of the list, a new Drugs Prices Control Order would also be in place to directly check the price of specific formulations.

While Ranbaxy did not answer TEHELKA’s queries, saying “the matter is sub judice and we cannot comment”, Cipla has not responded despite several calls and emails over the past two weeks.

shonali@tehelka.com

 

#India-Will you really get cheaper medicines?


RAJ PRADHAN | 23/11/2012 06:26 PM |   Moneylife.com

The government’s decision for simple average of market-based pricing for 348 drugs is simply a whitewash, according to many activists who were hoping for cost-based pricing. There may be marginal reduction in some medicine prices, but it legitimises overpricing of life saving drugs
After a delay of seven long years to decide on a comprehensive drug pricing policy, the Group of Ministers (GoM) has decided in favour of simple average Market Based Pricing (MBP) policy for price fixation of 348 essential drugs ostensibly to reduce drug prices. While drug companies may declare that it will impact their profit margins for some drugs, they must have sighed a relief that cost-based model is scrapped. MBP will legitimise overpricing of life-saving drugs.
At present, the government through the National Pharmaceutical Pricing Authority (NPPA) controls prices of 74 bulk drugs and their formulations through cost-based pricing. What happens to it? Dr Chandra M Gulhati, editor, Monthly Index of Medical Specialities (MIMS) says, “74 drugs under cost-based DPCO (Drug Price Control Order) will shift to the new policy (MBP) with substantial increase in prices.”
This new formula will fix the ceiling prices of medicines by calculating simple average of prices of brands of medicine having more than 1% share. This is a clear ploy to minimize the reduction in drug prices, to allow pharmaceutical companies to continue to charge inordinately high prices for their products. The complete divergence between the manufacturing costs of medicines and their present market prices (in case of those not presently under price control) has been widely documented.
The table below also shows that using simple average instead of weighted average (which was proposed) is hardly beneficial to patient.

Drug    Disease Market Based Pricing   (Weighted Average) Market Based Pricing  (Simple Average) Cost Based  Pricing
Metformin Diabetes Rs33 Rs35 Rs14
Atorvastatin High blood cholesterol Rs142 Rs127 Rs17
Atenolol High Blood pressure Rs51 Rs38.5 Rs8

Source: Jan Swasthya Abhiyan
The new policy allows a leeway for 10% p.a. increase in the prices of 348 drugs. According to Dr Gulhati, “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. 10% increase annual increase can mean adding Rs630 crore every year to total sales.”
According to S Srinivasan, managing trustee, LOCOST (Low Cost Standard Therapeutics), “The new drug policy is simplistic, still legitimates overpricing and full of loopholes.”
It may be recalled that responding to a petition by the All India Drug Action Network (AIDAN), the Supreme Court in 2003, had directed the government to devise a policy which would ensure that essential medicines are available at costs that ordinary people can afford. Further, the Supreme Court—while hearing arguments on this writ petition—had recently opined that the government should continue to use the cost-based formula for price fixation of 348 essential drugs.
JSA (Jan Swasthya Abhiyan—Peoples Health Movement—India) contends that though policymaking is the prerogative of the executive, the Supreme Court has acted well within its constitutional mandate in directing the government to take a policy which would stop the denial of the human rights of millions of Indian people. According to JSA, “As reported in the press, the Additional Solicitor General has reportedly advised the government that it need not follow the Supreme Court’s   suggestion to follow cost-based pricing under the pretext that policy making is the executive’s prerogative.”
JSA contends that Supreme Court’s suggestion is to protect human rights of citizens and ignoring it shows the disrespect for the Supreme Court’s attempt to protect right to life enshrined in the constitution; it’s tantamount to contempt of the SC.
According to Dr Anant Phadke of JSA, “We are hoping that at the next SC hearing on 27 Nov 2012, there may be something positive that will force the Government to rethink.”
The Jan Swasthya Abhiyan demands that

1)  The government should heed the Supreme Court’s opinion and impose price control on all 348 essential drugs and their derivatives, using the existing cost-based formula for price fixation.
2)  All escape routes used to wriggle out of the price regulation must be plugged. Thus all dosage forms of all 348 essential medicines and all fixed dose combinations of these medicines must be brought under price-control; (all irrational fixed dose combinations should be banned.) Otherwise in practice, the price regulation would be largely nullified.
3)  The government should immediately set up a committee of experts to list crucial medicines that—a) have been left out of the current list of essential medicines and   b) have been included in the essential drug lists of states but which are not currently included in the NLEM (National List of Essential Medicines).

 

India- Govt to bring essential medicines under price control #goodnews


 

, TNN | Sep 28, 2012, 12.54AM IST

Govt to bring essential medicines under price control
Once these essential medicines are brought under Drug Price Control Order (DPCO), it cannot be sold at a price higher than that fixed by the government.
NEW DELHI: India will, for the first time, put a cap on the maximum price at which essential drugs, like some commonly used anti-AIDS and anti-cancer drugs, besides a horde of painkillers, anti-TB drugs, sedatives, lipid lowering agents and steroids, can be sold in the country.

In a landmark decision, a group of ministers (GoM) headed by agriculture minister Sharad Pawar on Thursday cleared the proposal to bring all 348 drugs on the National List of Essential Medicines (NLEM) under price control. These drugs, with annual sales of around Rs 29,000 crore, account for about 60% of the domestic market.

Once these essential medicines are brought under Drug Price Control Order (DPCO), it cannot be sold at a price higher than that fixed by the government.

The GoM, which included health minister Ghulam Nabi Azad, decided on a “weighted average price formula”. This means the average price of all the brands sold in individual segments with a minimum market share of 1% will be the maximum retail price now.

The GoM will send its recommendations to the Cabinet within a week for approval. “The proposal will now go to the Cabinet which will take the final view,” Pawar said.

Prices rose 40% in 10 years

At present, the government, through the National Pharmaceutical Pricing Authority (NPPA), controls prices of 74 bulk drugs and their formulations. Drug prices have shot up phenomenally in India over the past decade and a half. There was a nearly 40% rise in all drug prices between 1996 and 2006. However, during the same period, the price of controlled drugs rose by 0.02%, while those in the Essential Drug List (EDL) increased by 15%. The price of drugs that were neither under price control nor under the EDL grew by 137%.

Interestingly, experts say there could a small downside to the proposal. “Price of costly drugs will definitely come down. But because the formula will put a cap on the MRP, the price of drugs for the same ailment, which are presently sold at a lower price, will go up,” experts said.

Minister of state for chemicals and fertilizers Srikant Jena said, “The GoM arrived at a consensus on the option which entails the use of weighted average prices for all the drugs which have a market-share of more than 1%.”

The concept of essential medicines, first introduced by the World Health Organization in 1977, has been adopted by many countries including India.

The list includes the most cost-effective medicines for a particular indication. Essential medicines are those that satisfy the priority healthcare needs of the majority of the population. The list is specific to India and addresses the disease burden of the nation besides being the commonly used medicines at primary, secondary and tertiary healthcare levels.

The latest NLEM 2011 has 348 medicines which cover 489 formulations, including 16 fixed dose combinations. These drugs are considered to be adequate to meet the common contemporary health needs of the general population of the country.

Planning Commission panel had suggested that all drugs on the NLEM should be brought under price control since the cost of medicines constitutes over 60% of the total cost of healthcare of Indians. The commission’s report had said, “Taking advantage of lax regulations on drug pricing, the pharmaceutical industry has been able to reap high margins through complex price setting activities.”

It added, “It has been observed that the price of a therapeutically similar drug could vary around 1,000% between the most expensive and the cheapest brands. The variation between the market and procurement price of similar drugs could range anywhere between 100% and 5,000%. The panel recommends price control on all formulations in the EDL.”

The report said direct price control should be applied to formulations rather than on basic drugs.

A note prepared by the drug controller general of India and available with TOI says, “A total of 348 medicines excluding repetitions are present in NLEM 2011. In NLEM 2011, 181 medicines fall under the category of primary, secondary and tertiary use, 106 medicines fall under category of secondary and tertiary use while 61 medicines are categorized as tertiary use only. In comparison to NLEM 2003, number of medicines deleted is 47 and 43 medicines have been added.”

It added, “Out of the 348 medicines, 37 medicines are currently under prices control by National Pharmaceutical Pricing Authority.”

 

“Free Medicines for All” soon to be a reality in Govt Hospitals


Feb 13, 2012 NEW DELHI: Free medicines to all patients visiting any government health facility across the country could soon be a reality with the health ministry ready to roll out a nearly Rs 30,000 crore ‘free-medicines-for-all’ scheme with the PMO‘s strong backing.

The free medicine initiative along with an expansion of the National Rural Health Mission to urban areas, a more district-oriented approach and implementation of recommendations of the K Srinath Reddy committee on universal health coverage will be important focus points of UPA-2’s health policy. The scheme is also expected to be strongly backed by the Sonia Gandhi-chaired NAC at a meeting on February 17.

At a meeting chaired by Pulok Chatterjee, principal secretary to the PM, on Friday, the medicine-for-all scheme and other thrust areas got a thumbs up with PM Manmohan Singh keen to roll out health sector initiatives. The medicine proposal will help cut India’s tremendously high out-of-pocket (OOP) expenditure on health care.

Speaking to TOI, a ministry official said, “We are ready to roll out the scheme which will provide free generic medicines to all those who visit government health care facilities across the country. This will reduce OOP expenditure and also encourage more people to visit government health facilities. However, we can’t make the announcement now with the elections on as it would violate EC guidelines.”

Instead of increasing public spending on drug procurement when millions of Indian households have no access to medicines, several large states have decreased fund allocation. Consider the case of Kerala. Even though the state spent the highest in India on drug procurement last year – 12.5% of its health expenditure – the expense was significantly less than in 2001, when it stood at 17%.

“We estimate that an increase in the public procurement of medicines from around 0.1% to 0.5% of GDP will ensure universal access to essential drugs, greatly reduce the burden on private OOP expenditures and increase the financial protection for households,” a report has said. Drug prices have shot up phenomenally in India over the past decade and a half. This has been the main reason for the rising costs of medical care, which more than tripled between 1993-94 and 2006-07.

Free Medicines in Rajasthan, India


India is known as the pharmacy of the world but 65% of Indians have no access to essential medicines. Watch this video to see how the State of Rajasthan in India is tackling the problem by promoting generic medicines and providing these free of charge in the public sector.

This week negotiations continue on the EU-India Free Trade Agreement. Worldwide there are serious concerns that the deal will include stricter intellectual property rules than necessary and result in a deadly escalation in medicine prices for developing countries. Such a deal would also threaten innovative and progressive schemes like this one in India itself.

 

Watch the Video here 

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