Need for Patient-Oriented Comprehensive Regulation of Medical Devices

Statement by Hip Implant Patients Support Group (HIPS) and All India Drug Action Network (AIDAN)

5 October 2019

  1. First and foremost, as civil society, patients and consumers using medical devices we have been alarmed and deeply distressed over the developments of the past month regarding price control measures on medical devices being subject to trade negotiations between the United States and India. Health should never be on the negotiating table in trade agreements especially when it creates impediments in our pathway for self-reliance in health technologies and affordability and accessibility of health services.

We also note with distress the haphazard manner in which consultations on this drastic move by the Indian government took place before the Honourable Prime Minister’s visit to the United States. We are taken aback that civil society and patients did not form any part of the formal consultative process held by the Ministry of Commerce on critical issues that affect our lives and health directly. In this regard we welcome the statement made by the Hon’ble Prime Minister at the United Nations High Level Meeting on Universal Health Coverage that “In our efforts to ensure affordable healthcare, we have slashed the cost of stents by 80% and cut down the cost of knee implants by 50 to 70%.”

We therefore call on the Ministry of Commerce to uphold the Prime Minister’s message and promise to ensure that not even an inch of India’s sovereignty to deal with the prices and affordability of medical devices is on the negotiating table in the ongoing trade talks with the US.

  1. Towards instituting a patient-oriented regulatory regime for medical devices, we believe there is a need to bring in urgent regulations and reforms in the following broad areas:
  • strengthen regulatory systems for ensuring product safety through adequate testing and laying down of norms for clinical trials and related investigations particularly for high-risk devices and implants
  • approval of foreign made devices: examine critically the data submitted by the manufacturers and relied upon by the foreign regulators for approval of devices before deciding to waive trial and testing requirements in India, and in general stop over-reliance on foreign regulatory authorities for granting licenses in India
  • statutory provisions to check unethical business practices in the marketing and promotion of medical devices that cover manufacturers, traders and institutions and greater scrutiny of conflicts of interest of doctors hired by manufacturers to promote or develop devices
  • standard treatment protocols for common procedures involving the use of medical devices and medical audits to curb irrational treatment
  • consistent post-marketing monitoring of performance of devices, particularly high-risk devices, including institution of patient registries
  • urgent need for revamping regulations pertaining to reporting and collection of adverse events and instituting systems to ensure responsiveness of the regulatory agency in dealing with device failures, including public awareness, statutory recalls and cancellation of licenses
  • provisions for compensation to victims of faulty implants
  • affordable pricing – instituting ceiling price caps on devices regulated under the Drugs and Cosmetics Act and commonly used consumables in order to make these critical devices accessible, reduce financial burden of patients to curb corrupt practices that are driving up the costs of healthcare

Each of the above points needs detailed discussion with civil society and patient groups before policy decisions are taken.

  1. In the wake of public health disasters such the Johnson & Johnson ASR metal-on-metal hip implants and global withdrawals due to safety concerns of pacemakers, bioresorbable stents, pelvic mesh, breast implants, etc., there is a growing recognition of the need for strengthening of our medical devices regulatory systems so as to avert risks to patients from faulty and untested devices.

Therefore, we are dismayed at the decision of the CDSCO’s DTAB to further relax the provisions in the Medical Devices Rules, 2017 for granting approvals to imported devices based on marketing approvals by foreign regulatory bodies and extend the waiving of clinical investigations for products approved in the EU through CE certification, in addition to regulatory approvals in US, UK, Australia, Canada or Japan.

CE approval for medical devices, particularly high-risk devices and implants, is a deeply flawed system and must not be used as the basis for allowing inadequately tested devices into the Indian market. Failed devices such as Abbott’s bioresorbable scaffold ABSORB and Johnson & Johnson’s ASR hip implants, among others were approved in India through CE approvals. The International Consortium of Investigative Journalists (ICIJ) has extensively highlighted the flawed system for CE marking approvals of high-risk devices, including weak clinical data requirements, in its recent investigation[1].

We find this development extremely disturbing and cause for grave concern to vulnerable patients in India, that are being exposed to devices that may not have proven safety profiles due to loopholes and corruption in foreign regulations. These devices are being made available solely based on approvals provided by foreign agencies, which neither are accountable to domestic customers, nor can be influenced by our regulatory organizations. The misery of patients is compounded by the fact that laws governing medical devices are toothless, especially when it comes to providing for patient care and support in case of failure of such devices, making reflied available for affected patients and bring erring manufactures to book for transgressions.

A move in this direction, especially at a time when the country is witnessing hundreds of patient’s lives ruined by ASR metal-on-metal hip implants developed by Johnson & Johnson is completely unwarranted and goes against the duty of the government to protect patients.

  1. Finally, we end with a call for better participation and consultation of civil society and patients in the framing and implementation of government laws and policies on medical devices and in the regular work of the medical device committees charged with approvals and monitoring of medical devices.

In Conclusion

We are deeply uncomfortable and principally opposed to consultative processes organised by the government in collaboration and with joint funding from industry. Instead, we support the Government in holding public consultations which engage all stakeholders on a level platform.

There are critical issues before the government, NPPA, CDSCO and medical device committees that require inputs from and proper consultations with civil society and patients. These consultations must take place in an open and transparent manner and through platforms free from even the appearance of industry influence or the appearance of greater weight being given to industry stakeholders and voices.

We once again urge the government to address speedily and urgently our concerns on price controls, approvals and post-marketing regulation of medical devics. In nearly every case of device failures or faults we see an inexcusable time lag between actions taken by foreign regulators and those taken by Indian regulators. This must be remedied as a matter of urgency. As we have pointed out earlier, the collection and response to adverse events in India is equally critical. With the recent developments of price control of medical devices ending up as a negotiating tool for the government and concerns over the framework for approvals and regulations, we regret that rather than patient safety and care, industry safety and care seems to be central to the government’s policies on medical devices. Patients and the health of millions in this country must be at the centre of government action.

For further information, contact:

Vijay Vojhala
Joint Convenor and President
Hip Implant Patients Support Group
9987642207
vijayvojhala[at]gmail.com

Malini Aisola
Co-convenor
All India Drug Action Network
7838381185
malini.aisola[at]gmail.com

Avaneesh Akhoury
Joint Convenor, HIPS
8450999052
avaneesh.akhoury[at]gmail.com

S. Srinivasan
Co-convenor, AIDAN
9998771064
chinusrinivasan.x[at]gmail.com

[1] see https://www.icij.org/investigations/implant-files/medical-devices-harm-patients-worldwide-as-governments-fail-on-safety/ and https://www.icij.org/investigations/implant-files/how-lobbying-blocked-european-safety-checks-for-dangerous-medical-implants/

AIDAN’s statement on negotiations on medical devices in the context of US-India trade deal

20 September 2019

The All India Drug Action Network (AIDAN) is shocked and alarmed at the developments this week that threaten a reversal of India’s long held position on safeguarding its sovereignty to control and regulate prices of essential medical devices.

It is evident that the government’s control of prices on medical devices has been the most prominent issue in negotiations around what is being referred to in the media as a “mini trade deal” between India and the United States (US). The US Government has applied extraordinary pressure on India against the price caps on coronary stents and knee implants. It is an indisputable fact that these price caps were greatly beneficial to the public and reduced out of pocket expenditure of families undergoing procedures involving these devices.

India’s price control regime operates under the Drug Prices Control Order (DPCO) issued under the Essential Commodities Act. Implemented by the National Pharmaceutical Pricing Authority (NPPA), price controls on stents were imposed in after irrefutable evidence gathered by the NPPA showing gross abuse and overcharging in the pricing of these essential medical devices.

At the behest of US medical device manufacturers, the issue of these price controls became a sticking point in US and India trade discussions and were among the reasons cited for the withdrawal of India’s GSP privileges by the US. At the time of the withdrawal of GSP benefits, the Indian government itself noted that the impact would be on a minor segment goods exported from India to the US. A letter by 44 US lawmakers has confirmed this and indeed pointed out that exports from India to the US have in fact increased. In light of this, it is extraordinary that the Government is proposing to endanger access to medical devices for crores of Indians.

The US pressure on India is aimed at preventing India from using further price controls to make medical devices affordable – critical interventions to address the dire unmet need in the country and to curb corrupt practices that drive up the costs of healthcare.

The process through which the US has leveled pressure on India leading up to the PM Modi’s visit to the US is deeply problematic and is evidenced by a most shocking incident, US Ambassador Kenneth Just attended meetings at the Commerce and Industry Ministry on September 17 with Indian Government officials where US medical device companies and their US-based lobbying arm, Advamed spoke against price regulations on devices. In our view, this constitutes unprecedented, bold-faced interference in India’s policy making, on an issue that concerns the health of millions of people.

US industry is also pressing India to replace price caps on medical devices with regulation of trade margins.  In the absence of price caps, the affordability of medical devices will continue to be compromised because trade margin rationalisation is a much weaker form of regulation that will finally leave retail prices unchecked, will not correct serious market distortion in medical devices and exclude manufacturers and importers from the ambit of regulation.

AIDAN believes that the attempt to secure trade margin rationalisation is a backdoor attempt to neutralize the price caps, which is the most effective way to make critical medical devices accessible to patients.

The US pressure is attempting to gravely undermine India’s laws (such as the DPCO) and its institutions, therefore ultimately harmful to the interests of Indian patients.

AIDAN urgently calls in the Indian government to uphold the rights of Indians to affordable medical devices. We urge the Modi Government to not negotiate any compromises on medical devices and to retain the full policy space to take measures to protect and advance public health. In particular, we reject any attempt to dilute price controls through the smokescreen of trade margin regulation.

Anti-Cancer Drugs: Caps on Trade Margins will still leave most patients poorer

AIDAN’s Statement on Government’s move to cap trade margins of 42 anti-cancer drugs

30 March, 2019 (data has updated after 15 May 2019)

All India Drug Action Network (AIDAN) appreciates the Government’s recent decision to curb profiteering in the pharma trade channel by capping trade margins on brands of 42 anti-cancer medicines. However, AIDAN is concerned that most anti-cancer medicines still very much remain unaffordable to most Indians because there is no curb on profiteering by pharma manufacturers.

  1. PROCESS LEADING UP TO EXERCISE OF TRADE MARGIN CAPPING/ ‘RATIONALISATION’
  • We note that the decision on trade margins was made in the absence of consultation to solicit the views of stakeholders, particularly patients who would be affected.
  • The formula itself was developed by the Standing Committee for Affordable Medicines and Health Products (SCAMHP), chaired by Niti Aayog, which is not equipped with the technical expertise housed at the NPPA nor the data for analyzing and designing a methodology to cap margins. It was unfortunately accepted by the NPPA without further due diligence.
  1. ARBITRARY SELECTION OF 42 ANTI-CANCER DRUGS FOR PURPOSE OF LOWERING PRICES
  • The selection of 42 drugs by the MOHFW was not based on consultations with stakeholders including patient groups. While we welcome the intervention to reduce prices for these 42 drugs, there are many equally high-priced anti-cancer drugs whose prices remain unaffordable and need to be curtailed.
  • For example, a strip of 5 mg tablets of Axitinib, used to treat kidney cancer, costs Rs. 41,737. A 50 ml bottle of Cetuximab, used to treat head, colon, rectum and neck cancer costs Rs. 94, A 45 mg vial of Ixabepilone, which is used to treat advanced breast cancer, costs approximately Rs. 72,000. A box of containing 150 capsules of Ceritinib, a targeted therapy for non-small cell lung cancer, cost Rs. 1,19,700.
  • High prices of several drugs in the cancer segment may be linked to patent barriers and monopolies. In these cases, we do not recommend the exclusive use of trade margin capping to bring down prices but rather the application of various policy tools to increase competition and bring about true affordability (see section on patented medicines).
  • A few medicines picked for this exercise such as paclitaxel, doxorubicin and bortezomib were already part of the NLEM 2015 due to which certain strengths and forms are under direct price control. It is a testiment to the inadequate scope of the DPCO that these medicines were included in the list of 42 cancer medicines, in spite of being essential medicines.
  1. FLAWS OF THE FORMULA
  • Under the formula, the 30% margin on the Retail Price is actually equivalent to a 42.8% markup from the Price to Stockist (PTS). This methodology is a radical departure from the existing practices of providing margins in the DPCO, which is to the detriment of consumers who would not get the full intended benefit of the 30% cap. A 42.8% markup provides excessively high margins to the trade. Moreover, the profit margins of manufacturers of these medicines continue to be uncontrolled and opaque.
  • The formula does not disturb the margins of companies before the medicines reach the stockist. This is a particularly glaring exclusion when it comes to the high margins of companies/entities importing drugs into India. It is encouraging that NPPA has asked companies to submit data on landed costs and we hope post the data collection, the data would be shared in the public domain and margin capping would be brought to subsume importing entities as well. Capping of margins should begin from the ex-factory price or the landed cost, whichever is applicable.
  • Even after the current exercise, there are wide variations in the prices of different brands of the same medicine (see Table 6). This needs to be corrected. We are wary of trade margin capping being expanded in isolation of other price lowering measures as it is inadequate in addressing market distortions. Uniform ceiling price caps for life saving medicines are much more effective.
  • Given the wide variation of prices and the extremely high prices of some medicines, graded margin capping should have been implemented. For the higher priced medicines, the percentage margin caps should have been accordingly reduced so as to limit the quantum of the margins in absolute terms. This has been ignored by applying a blanket margin cap of 30% of the retail price (or 42.8% markup over price to stockist).
  1. IMPACT OF TRADE MARGIN CAPPING IN ANTI-CANCER DRUGS
  • No data has been made available for five of the 42 anti-cancer drugs, namely, dasatinib, olaparib, olaratumab, osimertinib and ribociclib. Therefore, we are unable to assess the impact on prices for these drugs.
  • There is ample evidence that trade margins in trade were excessive prior to the regulation. Analysis of the data published by NPPA shows that theoretical markups in the trade channel were as high as 1500%. In fact for 388 out of 526 brands, the trade markups would have been greater than 100%.
  • NPPA’s attempts at price capping of trade margins of anticancer drugs is a welcome attempt. But we find that the prices are still high after capping.
Table 1: Overview of Percentage Price Reduction per unit
Percentage Price Reduction No. of brands As a percentage of total no. of brands
0 to <25% 127 24%
25% to <50% 169 32%
50% to <75% 167 32%
75% and above 63 12%
Total 526  

Source: AIDAN, recalculated from NPPA data, May 2019

Table 2: Overall Reduction per unit
Price Reduction No. of brands As a percentage of total no. of brands
Upto Rs 500 195 37%
Rs 500 to <1000 29 6%
Rs 1000 to <5000 159 30%
Rs 5000 to <10,000 82 16%
Rs 10,000 and above 57 11%
Total 522*  
Source: AIDAN, recalculated from NPPA data, May 2019
*Units not available for four brands
Table 3: Retail Prices per unit of brands of anti-cancer drugs before and after Trade Margin Capping
Retail Price Before After
Upto Rs 500 107 159
Rs 500 to < Rs 1000 70 60
Rs 1000 to < Rs 5000 98 175
Rs 5000 to < Rs 10,000 90 53
Rs 10,000 to < Rs 25,000 121 53
Rs 25,000 to < Rs 50,000 28 20
above Rs 50,000 8 2
Total 522* 522

Source: AIDAN, recalculated from NPPA data, May 2019
*Units not available for four brands

  • After this cap on the trade margin, single units of many drugs still cost patients anything from Rs 2000 to Rs 20,000 to Rs 43,000. When accounting for courses of treatment and the financial impact over a month or a year, the amounts are prohibitive and unaffordable for not only BPL but even middle-class patients.
  • Companies have traditionally kept MRPs artificially inflated even though huge discounts were being offered to patients. The price reductions, which in some cases are impressive, through trade margin capping is also an outcome of a specific abberation in the promotion of cancer drugs – one of hefty discounts and invisible offers (e.g., buy 2, get one free). The NPPA appears to have been able to account for these discounts based on the format in which data was collected from companies.
  • However, this is not an easily replicable model as the results are not guaranteed in other segments of health products where such marketing and promotion practices do not apply.
  1. INADEQUATE IMPACT ON PATENTED MEDICINES
  • In the case of patented medicines such as sunitinib, nilotinib, crizotinib etc., the exercise has led to negligible price reductions, in contradiction with the stated objective of increasing affordability. In fact the trade margin rationalisation legitimizes the high prices claimed by manufacturers.
  • We believe that the Government should take definitively steps to implement the public health safeguards provided in the Patents Act such as compulsory licensing and government use, to generate competition in the market to achieve the lowest possible price.
  • The recent statements by Vinod Paul, Member (Health) of Niti Aayog and chairman of the Standing Committee for Affordable Medicines and Health Products that, “The prices of patented drugs cannot be curbed and should not be curbed … In principle, it is a discovery and we should respect the innovation”[1] cast doubts about the commitment of the Government with regard to creating affordability of patented medicines. They go against the laws of the land and are an attempt to unduly influence the actions of the other Government agencies such as the Patent Office, the Department for Promotion of Industry and Internal Trade and the Ministry of Health and Family Welfare.
  1. ESCAPE HATCH CREATED DUE TO JANUARY 3, 2019 AMENDMENTS TO DPCO
  • A massive escape hatch has been created by amendments to Para 32 of the DPCO whereby any of the anti-cancer drugs can apply for an exemption from the DPCO on the basis of patents, even frivolous ones. The government appears to be in denial that para 32 supersedes public interest safeguards such as incorporates in para 19 and and provides a blanket exemption from the provisions of the DPCO.
  1. POSITIVE MOVE TO CHECK UNETHICAL MARGINS OF HOSPITALS
  • In respect of regulation of hospital margins, we welcome the move as a means to curtail the unbridled and unethical profiteering that hospitals are indulging in by taking massive margins. However, a 42.8% markup that hospitals will now enjoy is much too generous and must be brought down[2].
  1. NEED TO SAFEGUARD PRICE CONTROLS
  • The DPCO 2013 currently covers less than 10% by value of the Indian pharma market. It is a flawed instrument as it calculates price caps on a market-based simple average price methodology instead of a cost-plus method.
  • Curbing of trade-margins is being described and promoted as a new form of price regulation of medicines. AIDAN is opposed to using trade-margin capping as a substitute for price control over of all medicines, particularly for all essential and life saving medicines.

In summary, the current approach to price regulation through reduction of trade margins does not go far enough to offer an effective solution to high prices of anti-cancer medicines. It legitimises, in effect, the high prices of the brands of the 42 anti-cancer drugs and would not adequately reduce the financial burden of needy patients. AIDAN calls upon the NPPA to not limit itself to trade margin caps but to move ahead with cost-based price control over all essential and lifesaving medicines and their combinations. 

[1] https://theprint.in/india/governance/modi-govt-slashed-prices-of-cancer-drugs-just-not-for-the-costly-ones/205115/

[2] NPPA’s previous analysis shows that huge commissions are taken by hospitals across the entire range of medicines, consumables and medical devices. It has commonly been observed that medicines and consumables combined account for about a third to half of the total bill for hospitalization. Profit maximizing model of healthcare delivery in private hospitals can lead to irrational and inappropriate treatments and poor outcomes for patients.

 

For further information contact S. Srinivasan, chinusrinivasan.x[at]gmail[dot]com, Malini Aisola, malini.aisola[at]gmail[dot]com. Additional tables providing further analysis of the price reductions in anti-cancer medicines can be provided upon request.

 

AIDAN’s response to the DTAB sub-committee’s recommendations on FDCs

Thursday, 26 July 2018.

AIDAN welcomes the DTAB sub-committee’s report and its recommendations on the 349 FDCs which in summary are to ban 343 of the FDCs and to restrict/regulate the remaining 6 FDCs.

It reinforces our constant demand for approval, and use, of only rational medicines in India. Rationality needs to be demonstrated by safety, efficacy and therapeutic justification. None of the FDCs meet the criteria of a rational and safe FDC. The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs.

When the ban on FDCs was notified, pharma companies in court cases questioned the locus standi and powers of the Central Government to ban drugs in India. That issue has been settled decisively with the recommendations of the sub-committee led by Dr. Kshirsagar.

In the legal battle in which AIDAN was a petitioner (Civil Appeal No. 22972/2017 and related cases), the Supreme Court ruled that as long as the Government is satisfied that a drug has unacceptable safety, efficacy and/or therapeutic justification, it may ban or regulate or restrict it in public interest. The Court further clarified that for such satisfaction to be obtained, consultation with the DTAB is not mandatory. Therefore, another red herring was laid to rest. The case had also, hopefully, sent a message that new drugs including FDCs cannot be licensed by the States for manufacturing, without prior Central Government approval; as well as a message to pharma companies that the system cannot be gamed through bypassing regulatory requirements.

The important remaining issue of the 344+5 FDCs has finally been resolved, in compliance with the December 15, 2017 Supreme Court verdict, pending of course formal notification by the Ministry of Health and Family Welfare. With this development, India’s regulatory system and its judicial system stand redeemed.

We note however, that the FDCs under scrutiny account for approximately Rs. 2,500 crore in sales and represent only the tip of the iceberg. In our estimation, the market of unsafe, problematic FDCs in India is at least one fourth of the total pharma market valued at Rs. 1.3 trillion.

The task that remains is combating the continued prevalence of a very large number of FDCs of doubtful scientific validity which have somehow slipped through the net and been approved wrongly by the Central Government. Review of all such FDCs in the market is required in the interest of patient safety. Such a review had also been recommended by the Kokate Committee. Only then can India’s pharma regulatory system hope to garner respect across the world.

Finally, we are appalled at the pharma industry’s disinformation and claims that the recommendations of the sub-committee will deal a huge blow to it. We ask how an important action in favour of safe medicines can be construed as a “blow” and object to such misleading propaganda.

Response of Campaign for Dignified and Affordable Healthcare to the Delhi Government’s Draft Advisory 

Tuesday, 29 May, 2018

The Campaign for Dignified and Affordable Healthcare is a forum of patients and families, civil society groups and health experts that advocates for strengthening regulation of the private healthcare sector and for reforms to ensure ethical, respectful treatment of patients.

We welcome the proposed measures to lower the costs of treatment and bring more transparency and accountability to private healthcare services in the NCT. Indeed they are progressive in intent and signal a paradigmatic shift in governmental thinking.

But we are afraid, the measures need further careful consideration and legal vetting to ensure they do not get stuck in courts. This kind of reform requires a statutory mandate, which could come through substantial modifications to the Delhi Nursing Homes Registration Act 1953, the Act under which these measures are sought to be brought into force. Failing that, an entirely new Act would be required in order to accommodate the measures proposed. In the absence of such legal cover, we are afraid the Delhi government’s good intentions will be of little or no avail.

But because of the evident difficulty that the Delhi Government has in passing legislation due to the Centre’s drive to frustrate any initiative of the state government, it appears to have had no choice other than to go through a route which is unlikely to succeed.

The proposals have some merit but we do not see high prospects of them succeeding. Nonetheless, we are hopeful that there will be engagement with consumer and patient groups through a consultative process and look forward to participating.

It is unfortunate that a state government that is interested in acting to the benefit of patients is forced to intervene in an ineffective manner, even while the Centre refuses to take any meaningful steps towards regulating private hospitals or lowering the prices of medicines and consumables.

For further information, contact:

Malini Aisola, 7838381185 ; Jayant Singh, ‭8860157770

AIDAN’s response to Delhi Government’s Advisory 

Wednesday, 30 May 2018

AIDAN welcomes the recent proposals by the Delhi Government to reduce the cost of treatment in private hospitals in the NCT. This will be a boon to patients, especially poor patients, who find themselves seeking treatment in private hospitals in emergency situations. If these measures succeed, it can be a precursor for a whole lot of other radical changes needed in health services.

We would like to sound a note of caution on the legal instrument, namely the Delhi Nursing Homes Registration Nursing Act 1953 sought to be used to pass these measures. It will most likely end up as a matter of legal dispute and impasse.

AIDAN would like to suggest that a better legal instrumentality would be the Clinical Establishments Act (CEA). Building on the positive provisions of the Central CEA Act and modifying it after considering also some state-level versions would be an important step that can be initiated towards standardization of quality and costs of care in Delhi, one that is also on firmer legal footing.

We once again welcome the positive move by the Delhi Government aimed at reducing exploitation of patients and families, especially of poor patients. The proposals on capping of margins for drugs and consumables, and proposal to fix rates of investigation in due course are good supplements in the private sector to the free medicine and diagnostic initiatives of the government, albeit which need further strengthening. We are hopeful that there will be constructive engagement with consumer and patient groups on these and future proposals to address the runaway costs of healthcare and abuse of patients’ rights also linked to commercialization of health services

AIDAN statement: Concerns regarding the transfer of the Chairman, NPPA

We are deeply concerned about the manner and timing of the transfer of Mr. Bhupendra Singh, Chairman NPPA, a move which seriously impacts public interest particularly when measures are being taken to plug unethical profiteering.

The NPPA under the governance of Mr. Injeti Srinivas and Mr. Singh showed tremendous leadership. Mr. Srinivas was transferred even before the completion of one year following the price regulation of critical cardiac and diabetes medicines through public interest of the DPCO. During his term, Mr. Singh has taken many positive steps to ensure affordability of medicines and medical devices that discomforted the industry.

Notably, the NPPA undertook landmark price control of stents and knee implants. There was greater accountability to the public because of increased transparency and responsiveness to grievances of patients and the industry.

Enforcement was also significantly strengthened with the recovery of hundreds of crores due to overcharging by the industry. The NPPA also saw unprecedented success in the courts with its stands vindicated by favourable judgments passed by the Supreme Court and High Courts in most cases.

Finally, the NPPA took a proactive role in initiating monitoring of high margins charged by private hospitals in an effort to curb unethical profiteering.

We fear that Mr. Singh’s transfer in total disregard to the public interest is due to the pressure from the industry and corporate hospital lobby.
The pharmaceutical industry has long sought to undermine and weaken the NPPA in order to enable uninhibited profiteering and circumvention of the law. The recent price revise of coronary stents angered the US-based MNCs which ran a malicious campaign against the regulatory authority.

The final precipitating factor, we believe, was the report analyzing bills of four patients and which exposed the gross overcharging and misconduct of private hospitals. In this same report, the NPPA appealed for policy intervention to correct the injustice towards patients as it had reached the limits of its mandate.

By transferring out the Chairman, the institutions positive outlook towards consumers will be blocked and messages uncertainty for continuation of critical interventions to make medicines more affordable to the common man and to stem systematic looting in the healthcare industry. Not appointing a replacement will render the NPPA nonfunctional at a critical juncture when patients interest must be served.

The Government has the authority to transfer officers but that authority should be exercised in good faith. The manner of transfer creates a chilling effect on the functioning of NPPA. Further, it conveys a message of insecurity to the new incumbent which could prevent the new Chairperson from acting decisively.

Therefore, we ask that:
the Government reconsider its decision and allow Mr. Singh to complete his three year term in the NPPA, and;

the NPPA be made into a statutory body along with fixed term periods for the Chairman and leadership to ensure the independence and integrity of the regulator.