Draft Pharmaceutical Policy, 2017

The Department of Pharmaceuticals has circulated a Draft Pharmaceutical Policy, 2017 which can be accessed here.

The draft policy identifies the following key objectives:

a. Making essential drugs accessible at affordable prices to the common masses;

b. Providing a longer term stable policy environment for the pharmaceutical sector;

c. Making India sufficiently self-reliant in end to end indigenous drug manufacturing;

d. Ensuring world class quality of drugs for domestic consumption & exports;

e. Creating an environment for R&D to produce innovator drugs

It addresses a range of issues including indigenous production of API, quality control and regulatory approval, manufacturing arrangements, foreign direct investment, innovation and R&D and intellectual property. A major portion of the draft is devoted to pricing and makes various recommendations for the re-structuring of the NPPA and changes to the DPCO. 

A conference on the draft pharmaceutical policy is being organised by the Department of Pharmaceuticals on August 30 where various Ministries are expected to present relevant aspects of the policy to stakeholders for feedback. 

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 

Pharma Price Control Policy: Unrealistic and Unfair

Economic & Political Weekly (EPW) August 23, 2014 Vol XlIX No 34

S Srinivasan, T Srikrishna, Malini Aisola

Despite the government’s and pharmaceutical lobby’s claims and counterclaims, the Drugs (Prices Control) Order, 2013, which covers only 18% of the total domestic market of Rs 71,246 crore, has had very little positive effect as a price control policy. This article points out that the Order leaves out much that should have been included, while including much that should have been left out. Its provisions have made the playing field more uneven, with multiple ceiling prices, which is very unfair to consumers already dealing with an irrationally priced market

LP_Commentary_23August2014.inddLP_Commentary_23August2014.indd  LP_Commentary_23August2014.indd

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

 
 
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Generic Dava – Isse Behtar Kuchch Nahi…

DainikBhaskar

Why your medical bill is not coming down?

The price caps imposed by the Indian government on 348 drugs in 2013 have created only an illusion of control, keeping many medicines for conditions ranging from asthma to diabetes and heart disease beyond price regulations… reports The Telegraph. Read more

Moneylife reports that while market-based pricing can potentially reduce the price for two-thirds of essential medicines, there are far too many loopholes. Read more

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Infographic Source: The Telegraph

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