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.


Health groups irked by Supreme Court order on vaccine PSUs; mull fresh petition

Press release on behalf of the All India Drug Action Network (AIDAN) and co-petitioners

19 February 2018

Several health groups expressed their strong disappointment with the order of the Supreme Court (SC) of February 12, 2018, which refused to review or recall an earlier order disposing off a case against the mala fide suspension of the vaccine Public Sector Units (PSUs) and government’s tendency to pamper private sector with public money.

The court relied only on the Government’s claims regarding the revival and modernization of the suspended PSUs and did not take into account the last rejoinder of the petitioners that highlighted the increasing diversion of purchase orders to private sector at ever increasing prices. The groups are considering filing a fresh petition, as the court also said “in case there is any deficiency or neglect on the part of the Government…, the petitioner shall be free to seek appropriate redress in appropriate proceedings at the appropriate stage.”

The decade-old public interest litigation (PIL) was filed by former Union Health Secretary, S. P. Shukla and representatives of the All India Drug Action Network (AIDAN), Low Cost Standard Therapeutics (LOCOST), Medico Friend Circle (MFC), and Society for Scientific Values (SSV).

The chief petitioner S. P. Shukla said, “We won half the battle with the revival of the suspended PSUs and their modernization for compliance with good manufacturing practices (GMP), under the pressure of our court case and the report of the governmental Javid Chowdhury committee. But their production is yet to be restored to pre-suspension levels, the responsibility for mala fide suspension was not fixed, and even the recommendations of the Javid Chowdhury Committee have not been fully implemented.”

According to S. Srinivasan of LOCOST, one of the petitioners, “The union government has not been buying vaccines from the public sector even after their revival. Government data show that the purchase orders to PSUs are declining and those to private companies are growing despite increasing prices. We highlighted all these issues in our last affidavit of 2016 to show that the Government of India is misleading the Supreme Court, but it was not taken into account before disposing off the petition.”

“We neither have a rational vaccine policy nor rational use of vaccines – for example, selective immunization has disappeared from government policy. New vaccines and their combinations of doubtful efficacy and safety are being introduced in the universal immunization programme. By shifting its procurement towards irrational cocktail vaccines made only by the private sector, the government is systematically reducing PSUs into component suppliers to the private sector”, said Dr. Mira Shiva of AIDAN, another petitioner.

N. Sarojini from MFC remarked, “Due to lack of government orders, the revived PSUs are forced to find private buyers for survival. Prior to suspension, the public sector supplied 85% of all universal vaccines procured by the government. Today, over 90% of the government purchases are from private sector.”

On behalf of the SSV, Prof. N. Raghuram stated, “Vaccines are prescription drugs but are being promoted like consumer goods through private immunization camps. It is unethical that all these dubious practices are being done in the name of children as they cannot decide the vaccines they need. Someone must give a credible answer to helpless parents’ question as to how many vaccines are adequate for a child.”

Response to the announcement by All India Syringes and Needles Manufacturers Association (AISNMA) to voluntarily reduce trade margins to 75% on ex-factory prices

December 22, 2017.

We welcome the announcement by the syringe and needle manufacturers of their intention to reduce prices. However, throughout history self-regulation has never been an effective solution and often compromises transparency.

This initiative is a voluntary action by a group of Indian manufacturers to cut prices and its success depends on the willingness of all manufacturers to conform to the proposed reduction in trade margins and set lower MRPs. At the moment, not all the companies particularly the multinational companies are part of the initiative.

It is a well-known fact that it is the private institutional buyers that are taking maximum advantage of high MRPs to reap big profits. These players can still force manufacturers or a section of them to continue business per usual, at the expense of consumers. Such a scenario would be avoided under Government regulation that applies uniformly to all manufacturers.

Because of the misalignment of business interests with patient welfare, regulation in healthcare exists as the norm rather than exception around the world. The Government has a constitutional obligation to protect people from the exploitation of third parties and therefore needs to intervene to ensure affordability of medical devices.

Self-regulation does not guarantee compliance and cannot be enforced. Regulation is essential for enforcement and also works in favor of the long-term health of the domestic industry by ensuring a level-playing field is maintained across manufacturers.

Therefore, we call upon the NPPA to

– first and foremost publish data on the trade margins involved in medical devices notified as ‘drugs’ under the Drugs and Cosmetics Act and Rules falling in 19 categories that remain outside the purview of price regulation, and
– act without further delay to impose price caps as the only appropriate and sustainable measure to ensure affordability of these critical devices.

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

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.

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:


All India Drug Action Network (AIDAN)


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.

– 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.

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: