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Landmark decision of the Supreme Court clarifies pathway for banning of unsafe drugs

PRESS STATEMENT
14 December 2017, New Delhi.

The All India Drug Action Network (AIDAN) welcomes the pronouncement in Union of India & Anr. vs. Pfizer & Anr. (SLP(C) 7061 of 2017) delivered today by Justices Nariman and Kaul as a major step towards weeding out of irrational, unscientific fixed-dose combination (FDC) drugs in India.

AIDAN filed a Special Leave Petition in the Supreme Court, alongside the Government’s own petition, challenging an order of the Delhi High Court that quashed the ban of 344 FDCs in December 2016 on the grounds that the statutory Drugs Technical Advisory Board (DTAB) had not been consulted by the Government.

The 344 FDCs in question were banned on the recommendation of the Government-appointment Kokate committee, which was set up to look into safety and efficacy of FDCs that lacked regulatory approval from the Central Government. The Kokate committee had deemed these FDCs irrational and accordingly the Government notified a ban on them.

The pharmaceutical companies represented by eminent lawyers such as Mr. P. Chidambaram, Mr. Kapil Sibal and Mr. Gopal Subramaniam were dealt a blow when the bench mentioned that:

  • For the exercise of powers under Section 26 (A) of the Drugs and Cosmetics Act, the DTAB need not be mandatorily consulted by the Government in order to be convinced of reasons for banning a medicine. The Court remarked that the Government could be justified in declaring a ban even if it finds that the drug has been banned in other countries.
  • Regarding the alleged perversities and anomalies pointed out by the companies in the Kokate report, the Hon’ble Court mentioned that the DTAB, on its own or through a sub-committee of experts appointed by it, should examine the Kokate committee findings hearing all parties including AIDAN. The recommendations of the DTAB or its expert sub-committee should be made to the Central Government within six months, which will further act if and where necessary. The Court also declared that it will direct the committee to clearly specify reasons against each of the FDCs as to whether it has safety or efficacy problems or lacks therapeutic justification and whether it recommends that the said drug be prohibited, restricted or regulated.
  • The DTAB or sub-committee will not consider a small number of FDCs, which were notified for banning on the basis of the Kokate committee report but which the pharma companies claimed were approved prior to September 1988. However, the Government is free to de novo look into such FDCs.
  • The question of the ban on 294 FDCs, stayed by the Madras High Court in 2008, was also deliberated and the Court asked the Government to take suitable action.

“The 344 FDCs account for only about 5% of the value of total FDCs in India, approximately half of which are considered to be irrational. The Government should proactively take advantage of the space afforded by this order to weed out other irrational FDCs in the interest patient safety,” said Mr. S. Srinivasan, co-convenor of AIDAN.

The Court’s remarks clear the ground for the Government to rapidly take steps after due consultation with expert bodies or consideration any other information to weed out large numbers of irrational, unscientific and hazardous FDCs that are unjustifiably prevalent in India.

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AIDAN Press Statement: Indian Government should reject the bullying tactics of the US based medical device industry

The US-based medical devices industry through the Advanced Medical Technology Association (AdvaMed) has approached the US Trade Representative (USTR) with a demand to partially or fully suspend or withdraw India’s benefits under the Generalized System of Preferences (GSP). This is a barefaced attempt to intimidate the Indian Government and retaliate against its decision to fix the retail prices of cardiovascular stents and knee implants in the public interest.

This issue is supposed to be discussed at the US India Trade Policy Forum to be held in Washington DC on 26th October. Against this background, the All India Drug Action Network (AIDAN) has issued the following statement:

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All India Drug Action Network (AIDAN)

PRESS STATEMENT

Access to health products is non-negotiable; the Indian Government should reject the bullying tactics of the US based medical device industry

25 October 2017, New Delhi

The All India Drug Action Network condemns the pressurising tactics of the US based medical device industry to undermine the Indian Government’s actions to make health products more affordable and accessible for millions of people.

The move of US multinational companies through the industry association, Advanced Medical Technology Association (AdvaMed) to approach the US Trade Representative (USTR) with a demand to partially or fully suspend or withdraw India’s benefits under the Generalized System of Preferences (GSP) is highly reprehensible. This is a barefaced attempt to intimidate the Indian Government and retaliate against its decision to fix the retail prices of cardiovascular stents and knee implants in the public interest and exposes the unabashed greed of the industry and its willingness to hold poor peoples’ health at ransom for the sake of maximising profits.

In the past, the US biopharmaceutical industry has used similar tactics – backed by the US government – to pressurise the Department of Industrial Policy & Promotion (DIPP), Ministry of Commerce and Industry to roll back decisions related to the rejection of patents on critical medicines such as sofosbuvir for hepatitis C. The US pharmaceutical lobby has also attempted to create barriers for the issuance of compulsory licenses on patented cancer medicines such as dasatinib, which are priced out of reach of most patients in India. Such pressurising tactics are now being applied by US corporations like Abbott, Boston Scientific and Johnson & Johnson to try and get the Indian government to dilute/reverse price control measures on essential medical devices that are increasingly being used to save lives and improve quality of life, and also to preclude policy interventions to safeguard the public health of people in India.

The well-thought-out decision to regulate the prices of cardiovascular stents and knee implants put an end to the rampant overcharging and the exploitation of patients by hospitals and doctors in collusion with companies.

Opposition to price control on coronary stents and knee implants

In the case of stents, data collected by the National Pharmaceutical Pricing Authority (NPPA) clearly show that cardiovascular stents were being sold by hospitals at extremely high markups from the price at which they were procured (for example, 436% for bare metal stents and 654% in the case of drug eluting stents, on average). This was an outcome of unethical business practices, established and institutionalised by the leading foreign stent manufacturers, which rely upon commissions to hospitals and kickbacks to members of the medical fraternity to boost sales and gain market share. Helpless patients were therefore being charged artificially inflated prices that bore no relation to the manufacturing or import costs.

Official investigations of the Maharashtra and Odisha Food and Drug Administrations have repeatedly documented unethical practices in respect of numerous other medical devices. The companies are cleverly trying to thwart much-needed governmental intervention to correct the prevailing situation of market failure and widespread exploitative pricing in medical devices.

The grievances propagated by the US medical devices industry are disingenuous on two other fronts. The Indian Government rejected the companies’ demand for differential pricing for cardiovascular stents based on claims of innovation due to the complete lack of any data to support such claims. In fact these companies (Abbott Healthcare, Boston Scientific and Medtronic) failed to submit verifiable and credible evidence to demonstrate clinical superiority of the so-called “innovative” stents. Closer scrutiny of the “innovative” stents showed that they are actually “me-too” products that were being sold at a premium in order to create more profits, to the detriment of patients.

Companies have also asserted that stent price control has resulted in major losses and will limit their ability to bring advanced stents to India. However, the Government’s capping of prices did not in any way impact on the margins of the companies, which remain highly profitable. Action was only taken to curtail the illegitimately high trade margins, particularly those being provided to hospitals.

We are outraged by the companies’ relentless propaganda and threats to withdraw high-end products from the Indian market in light of the huge profits they have made over decades while undeniably patients were being fleeced. Whereas in the US, the same companies and colluding hospitals have paid massive penalties for cheating the public, no actions have been taken in India to penalise companies for overcharging or to recover money on behalf of the people.

US based companies manufacturing orthopaedic implants have protested the Indian Government’s action to make knee implants more affordable and expand access for huge numbers of patients in need of knee replacements. The list of complaints – loss of profits, disincentive for innovation, etc. – lack merit as in the case of stents. Yet the industry continues its campaign of spreading misinformation.

The price control on stents and knee implants has stopped unethical marketing practices to a certain extent and brought a degree of relief to patients and their families. Any move to withdraw or weaken price controls would expose patients to exploitation and amount to a denial of access to affordable healthcare, particularly in the private sector system.

Therefore,
– We call on the government of India to uphold the constitutional obligation on right to health and reject any pressure to review price controls on medical devices.

– We ask that price controls are urgently expanded to cover 19 additional categories of medical devices classified as drugs under the Drugs and Cosmetics Act and Drugs and Cosmetics Rules.

– We call on the US government to refrain from exerting policy pressure on India for taking measures to make medicines and medical devices more affordable and accessible to patients that need them.

– We appeal to the Government of India to approach the Competition Commission of India to carry out an investigation into prevalent anti-competitive practices in the marketing of medical devices, especially stents and orthopaedic implants.

Maharashtra and Odisha FDA Reports showcase huge profits in medical devices

In a widely celebrated move that was expected to benefit heart patients, the National Pharmaceutical Pricing Authority (NPPA) capped the prices of coronary stents in February 2017. Unfortunately, prices of all other medical devices with the exceptions of condoms and IUDs remain unregulated.  

Given that medical devices are critical, unavoidable components of healthcare, this situation of free pricing represents a massive undue burden on patients. A recent spate of media reports confirm widespread financial exploitation of patients with respect to commonly used devices such as intraocular lenses, catheters, orthopedic implants and surgicals.  

In the last month the NPPA has undertaken an exercise to gather data for 19 medical devices that are classified as ‘drugs’ under the Drugs and Cosmetics Act, 1940, in order to monitor their prices. However these data have not yet been made public.       

A lesser known fact is that the Food and Drugs Administrations (FDAs) of Maharashtra and Odisha states have carried out multiple investigations into the pricing and marketing of medical devices over the last several years. In fact, original investigative reports on coronary stents (Odisha FDA, 2014 and Maharashtra FDA, 2015) provided the impetus for price control. 

In the interest of increasing transparency and making the data and findings of these investigations available to the public, we are publishing the reports of the state FDAs. 

We are thankful to Mr. R. P. Y. Rao, Society for Awareness of Civil Rights, Mumbai for the reports of the Maharashtra FDA which were obtained through RTI requests.

The documents

The FDA reports are replete with data for a wide spectrum of devices including coronary and peripheral stents, intraocular lenses, cochlear implants, pacemakers, catheters, syringes and needles. The studies provide hard evidence of hefty margins at each step of the supply chain and document business practices designed to give super profits to hospitals, distributors and companies. 

On the basis of these studies, the FDAs have repeatedly sent recommendations to the Central Government aimed at increasing affordability of medical devices and curtailing the extortion of patients. A key proposal has been to bring in more medical devices under the definition of ‘drugs’ under the Drugs and Cosmetics Act which would further permit regulation of their prices. The state bodies have proposed regulating prices and trade margins under the Drug Prices Control Order (DPCO) either through the route of addition to the National List of Essential Medicines or the use of public interest provisions contained in Paragraph 19.  

Maharashtra FDA

Recommendations based on Study Report on Pricing of Balloon Catheters and Guiding Catheters, June 2017

Study of surgical equipments/instruments, medical devices not under the purview of DPCO, 2013 and proposal to Central Government to notify them as ‘drugs’ and bring them under the DPCO (2013), June 2017

Enquiry report on pricing of stents, May 2015

Proposal to notify certain medical devices as ‘drugs’ under Drugs and Cosmetics Act (1940), August 2011

Note on Life Saving Medical Devices & Anticancer drugs, Antibiotics & Anticoagulants which are sold at exorbitant prices

Odisha FDA

Recommendations based on Detailed Survey Report on Medical Devices, December 2014

The documents mentioned above can be accessed at the Dropbox hosted folder available here: https://www.dropbox.com/sh/db1f6q4l8fh07my/AAB2no7wf5m2NfGxDdFz8hqBa?dl=0 

Civil society letter on NPPA’s action on price control

Shri Ananth Kumar
Hon’ble Minister of Chemicals and Fertilizers
Udyog Bhavan
New Delhi 11001
 
20 August 2014
 
Dear Ananthji,

 

The National Pharmaceuticals Pricing Authority (NPPA), on July 10, 2014, released a new set of price notifications for 50 cardiovascular and diabetes medicines under paragraph 19 of the Drug Prices Control Order (DPCO), 2013. The notifications for the 108 formulations (two were subsequently withdrawn) of these selected medicines are in addition to the notifications for essential medicines declared under the DPCO 2013. We note that the earlier notifications for essential medicines excluded several dosage forms and strengths because they did not feature in the National List of Essential Medicines (NLEM), 2011. Thus the recent notifications were necessary to cover more of the strengths of medicines than that are listed on the NLEM. In addition, the notifications also covered medicines in the cardiovascular and diabetes therapeutic categories that are not included in the NLEM.

We the undersigned civil society organizations welcome the initiative of the NPPA to cap the prices of formulations involving essential and lifesaving medicines that fall outside the NLEM as a first step towards the institution of a robust, pro-public health policy of drug price control. This is an action that truly interprets the spirit of the Drug Prices Control Order, and its underlying legislation the Essential Commodities Act, 1955. In the past, despite its attention being drawn to the profiteering in medicines not listed in the DPCO, the government had looked the other way.

We are surprised at the misinformation being spread by the Pharmaceutical Industry in this regard, and its efforts to prevent relief to the consumer by filing petitions in the high courts in Mumbai and Delhi. Industry has challenged the legality of fixing the prices of the 50 medicines under Paragraph 19 of the DPCO 2013 when in fact the Government has in successive drug price control orders always retained the power to intervene in prices in the public interest in the light of evidence of overpricing.

Limiting all price regulation only to a list of 348 medicines and specified dosages and strengths in the DPCO 2013 goes against the policy objective of making medicines affordable to the public. The National List of Essential Medicines, a list of 348 rational and cost-effective medicines, is not the basis for production, promotion and prescription in India. In reality the most frequently prescribed and consumed medicines are not listed in the NLEM.

Industry has claimed that this will cause an annual loss of revenues of over Rs.600 crores. NPPA’s action on the market will however be marginal, and nowhere near the doomsday predictions of the industry. It will affect only those brands that were selling at very high prices. We have analysed the impact of the notifications and found that the retail market of Rs.77,526 crores (Moving Annual Total, June 2014) would experience a loss of  Rs. 350 crores (AIOCD-AWACS, PharmaTrac Data, 2014).  This represents a loss of approximately only 2% (Rs. 112 crore) in the anti-diabetic therapy segment and 2.5% (Rs. 238 crore) in the cardiac therapy segment. This in a way establishes the excess profits of the industry in those particular formulations by overcharging the patients.

Also the market based price fixation being followed by the NPPA, a departure from the long used cost-based price control mechanism, is irrational and means that the ceiling prices are still very high. Many medicines are sold by reputed companies much below the NPPA ceiling price. The ceiling price of atorvastatin 40mg is Rs. 22.02 per tablet while Biochem Pharmaceutical is selling the same at a much lower price of Rs. 14.94 per tablet. The ceiling price of glimepiride 3mg is Rs. 10 per tablet, while Ipca Laboratories is able to sell it for Rs. 6.90 per tablet. As per our calculations only a little over one fourth of packs selling on the market will need to revise their prices downwards because they were originally priced higher than the notified price. This is evidence that there is a scope for significant reduction in NPPA ceiling prices, without affecting the reasonable profits of the industry.

We also note that the notifications have not included fixed dose combinations in the cardiovascular and diabetes therapeutic categories whereas the sales of many combinations exceed those of the single molecule medicines.

We also raise the argument that fixing of ceiling prices of all the other dosage forms of all medicines under NLEM cannot be neglected. Here again the same phenomenon of overcharging remains. NPPA should come out with similar action to cover all dosage forms and fixed dose combinations containing one or more medicines under NELM, and as well as bring other essential and life saving medicines under price control immediately.

Although this notification of NPPA will give some relief to patients in the chronic disease sector in the present context, it should be expanded and rationalized. We request the Government and NPPA to strongly defend its stand and also consider the actions suggested by us to promote public health.

Signed,

All India Drug Action Network (AIDAN)
Jan Swasthya Abhiyan
Low Cost Standard Therapeutics (LOCOST)
Medico Friends Circle
Third World Network- India
All India Peoples Science Network (AIPSN)
National Working Group on Patent Laws

 
Copy to:
Hon’ble Shri Narendra Modi, Prime Minister of India
Hon’ble Shri Dr. Harsh Vardhan, Minister of Health and Family Welfare
Mr. Nripendra Misra, Principal Secretary, Prime Minister’s Office
Mr. Lov Verma, Secretary, Department of Health & Family Welfare, Ministry of Health & Family Welfare
Ms. Aradhana Johri, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers
Mr. Injeti Srinivas, Chairman, National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers

 
 
 
For further information, contact:
 

LOCOST
1st Floor, Premanand Sahitya Bhavan
Dandia Bazaar
Vadodara, Gujarat – 390001
Ph: 9998771064
Email: chinusrinivasan.x@gmail.com

Jan Swasthya Abhiyan
National Secretariat
c/o Delhi Science Forum
D-158, Lower Ground Floor
Saket, New Delhi 110017
Ph: (011) 26524323, 26862716
Email: jsasect.delhi@gmail.com

 
 

Fresh plea filed against drug price control in SC by AIDAN & others

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Mumbai: Non-government organisations (NGOs) led by AIDAN (All India Drug Action Network) have filed a fresh application in the Supreme Court as part of their decade-long petition that had forced the government to bring all 348 essential drugs under price control. AIDAN, LOCOST, Medico Friend Circle and Jan Swasthya Sahyog together have filed a fresh intervention application in the Supreme Court, opposing the National Pharmaceutical Pricing Policy (NPPP 2012) and marketbased pricing mechanism to determine ceiling prices of drugs which are being brought under price control.

According to the fresh intervention application, the simple average formula to determine the ceiling prices (of drugs) actually increases their prices and… read more

Source: Times of India

Fresh plea filed against drug price control in SC

The EU says no to ACTA: to protect public health, other countries should also reject it

Posted by Leila Bodeux on Jul 12th, 2012 in Access to medicines | Global Health Check

The European Parliament (EP) made a landmark decision to reject the Anti-Counterfeiting Trade Agreement (ACTA), by a majority of 478 votes out of 682.  The Agreement was negotiated between the EU, United States, Australia, Canada, Japan, Morocco, New Zealand, Singapore, and South Korea….. ACTA is dangerous because it is not strictly limited to countering trade in true “counterfeiting”, defined narrowly under the WTO TRIPS Agreement as the “deliberate, fraudulent use of a trademark in order to deceive consumers”. Instead, ACTA creates severe penalties in connection with a range of types of IP infringement and IPR disputes, most of which have nothing to do with counterfeiting. For instance,…. read more

Supreme Court Order in the AIDAN Drug Pricing PIL – Oct 11, 2011

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ITEM NO.101 COURT NO.7 SECTION PIL
S U P R E M E C O U R T O F I N D I A
RECORD OF PROCEEDINGS
WRIT PETITION (CIVIL) NO(s). 423 OF 2003
ALL INDIA DRUG ACTION NETWORK AND ORS. Petitioner(s)
VERSUS
UNION OF INDIA AND ORS. Respondent(s)

(With appln(s) for permission to submit additional
document(s),PERMISSION TO FILE ADDITIONAL AFFIDAVIT)
Date: 11/10/2011 This Petition was called on for hearing today.
CORAM :
HON’BLE MR. JUSTICE G.S. SINGHVI
HON’BLE MR. JUSTICE SUDHANSU JYOTI MUKHOPADHAYA
For Petitioner(s) Mr. Colin Gonsalves, Sr. Adv.
Mr. Anuj Castleino, Adv.
Ms.Jyoti Mendiratta,Adv.(Not present)
For Respondent(s) Mr. T.S.Doabia, Sr. Adv.
Mr. Ashok Bhan, Sr. Adv.
Ms. Rekha Pandey, Adv.
Ms. Sadhana Sandhu, Adv.
Mr. R.K.Rathore, Adv.
Ms. Asha G. Nair, Adv.
Mr. Shalinder Saini, Adv.
Mr. P. Parmeswaran ,Adv(Not present)
Mr. D.S. Mahra ,Adv(Not present)
UPON hearing counsel the Court made the following O R D E R

At the commencement of hearing Shri Colin Gonsalves,
learned senior counsel appearing for the petitioners read
out portions of 45th Report of the Parliamentary Standing
Committee on Health and Family Welfare and 7th Report of the
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Standing Committee on Chemicals and Fertilizers.
Thereafter, Shri Doabia, learned senior counsel appearing
for the Union of India placed before the Court a photostat copy of the Office Memorandum dated 20.06.2011 sent by the
Ministry of Health & Family Welfare to the Secretary,
Department of Pharmaceuticals on the issue of revision of
National List of Essential Medicines. Paragraph 2 of that
memorandum reads thus:
“2. In the above connection, it may be
stated that the National List of Essential
List (NLEM), 2003 has been revised. The
revised list, the NLEM, 2011 contains 348
drugs. While approving the list, the
Minister of Health & Family Welfare has also
approved that if affordable healthcare has
to become a reality, all the medicines
included in the NLEM, 2011 should be brought
within the ambit of price control under the
DPCO, considering the fact that the cost of
medicines in the overall cost of healthcare
constitutes more than 60% and a large
percentage of our people do not have access
to affordable healthcare. If, at all, such
medicines cannot be included under DPCO with
the same trade margins, there could be
graded system of trade/profit margins for
different categories and 348 medicines in
NLEM, 2011 could be so categorized. This
will ensure that reasonable margins and
growth of Pharma industry also do not get
adversely affected. The Minister has,
therefore, approved taking up the matter
with the Department of Pharmaceuticals for
further appropriate action.”
Shri Ashok Bhan, learned senior counsel appearing
for the Department of Chemicals and Fertilizers also placed
before the Court a xerox copy of Office Memorandum dated
04/05.10.2011. In para 6 thereof, it is mentioned that the
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Department of Pharmaceuticals is examining all the
possibilities of control and monitoring of prices of
medicines including those covered under the NLEM, 2011.
Having perused the two Office Memorandums placed by
the learned senior counsel for Union of India and Department
of Chemicals and Fertilizers, we deem it proper to direct
the Secretaries of two Ministries to file their affidavits within four weeks indicating therein as to within what time
the revised list of National List of Essential Medicines
(NLEM) will be added in Schedule-I of the Drugs (Price
Control) order, 1995.
A comprehensive revised list of National List of
Essential Medicines (NLEM) be also produced along with
affidavit to be filed on behalf of the Ministry of Family &
Welfare.
List the case on 17.11.2011 for further hearing.
(Parveen Kr. Chawla) (Phoolan Wati Arora)
Court Master                Court Master