Category Archives: AIDAN Press Releases

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/

Open letter to DG, WHO – Pentavalent vaccine related deaths in India

To

Dr. Margaret Chan The Director General, World Health Organisation, Geneva

Dear Dr Margaret Chan,

All India Drug Action Network (AIDAN) is a network of not-for-profit civil society organisations that has been campaigning and working for rational use of medicines, largely in the Indian context. We have written to you in the past. We would like to bring your attention to the deaths Pentavalent (DPT + Hib + Hepatitis B) vaccine related deaths in India.

According to the Brighton classification of ‘adverse events following immunization’ (AEFI), re-challenge and recurrence of symptoms in the individual is needed for classification of AEFI as ‘certainly related to vaccine’. Such re-challenge is impossible if in the first instance, AEFI results in death. In the absence of proof from a re-challenge experiment, deaths caused by vaccines can only be classified as ‘probably related to vaccine or possibly related’ to the immunization.

As you would know, there have been several Pentavalent vaccine related deaths in Sri Lanka, Bhutan and Pakistan. Using the WHO approved classification of AEFI many of these deaths are ‘probably related to the immunization’ because no alternate cause for the adverse events has been found. However an expert panel looking at the deaths in Sri Lanka deleted ‘probably related’ and ‘possibly related’ from the classification of Brighton for purposes of their evaluation report, and then certified that the vaccines were ‘unlikely to be due to the vaccines’. This report (Expert Panel Report 23 December 2008 Sri Lanka) is available on the World Wide Web.

One by one the WHO has delisted a number of brands of prequalified Pentavalent vaccine, but the problem has refused to go away. Pentavalent vaccine was introduced in two states in India on 14th December and 17th December 2011, to evaluate the safety of the vaccine in India. According to an affidavit filed in the Kerala High Court by the Government of Kerala India, there have been four deaths in less than two months since it was introduced in the public health system. For your information the full text of the submission by Kerala government can be accessed here.

The reactions in India suggest that the cause of the problem is unrelated to the brand or manufacturer or lot of the vaccine. It appears to be a form of ‘hypersensitivity reaction’ as described in the post mortem report on one of the children in Kerala. The vaccine can be administered to many patients without problems and there is no available method at present to predict which infant will react adversely. The US FDA has pointed out that vaccines are aimed mostly at healthy individuals for prevention of diseases to which an individual may never be exposed. Unlike conventional drug treatments meant for the management of existing disease, in prophylaxis with vaccines, safety is of paramount importance. Vaccines that frequently and unpredictably cause death of healthy children cannot be recommended.

Pentavalent vaccine is at present recommended by WHO and its introduction is supported by GAVI funds. Given these circumstances the WHO needs to re-evaluate the recommendations. We propose to copy this letter to countries supporting the GAVI initiative so that they may be able to initiate action in a responsible manner.

Looking forward to your early action in the regard.

1. Dr Jacob Puliyel, Drug Action Forum – Karnataka (DAF-K), New Delhi

2. Dr Mira Shiva, Medico Friend Circle, New Delhi

3. Dr Gopal Dabade, DAF-K, Dharwad

4. Mr Srinivasan. S, LOCOST, Vadodara

5. Mr Naveen Thomas, Headstreams, Bangalore

6. Mr Prasanna Saligram, AID India, Bangalore

7. Dr Anurag Bhargava, JSS, Chattisagarh

ALSO READ: Vaccine woes continue, Down To Earth, March 12, 2012

NGO asks WHO not to support Wyeth’s anti-pneumonia vaccine

The Economic Times, Delhi edition dated Sep 18, 2008 (Page Number 26) carried news about Drug Action Forum of Karnataka (DAF-K) open letter to World Health Organisation (WHO) regarding the pneumococcal conjugate vaccine.

GLOBAL pharma major Wyeth’s vaccine Prevenar is caught in dispute as the Drug Action Forum of Karnataka (DAF-K), a member of All India Drug Action Network (AIDAN), has asked the World Health Organisation (WHO) to withdraw its support for the pneumococcal conjugate vaccine.

NGO asks WHO not to support Wyeth’s anti-pneumonia vaccine

In an open letter to WHO, the Karnataka-based forum said a recent study revealed that the vaccine does not reduce clinical pneumonia and is likely to cause asthma in children. “It has been found through studies that the vaccine reduces a rare type of pneumonia called radiological pneumonia and only about 4 cases are prevented for every 1,000 children immunised and what is even more dangerous is that for every four in whom pneumonia is prevented, two children develop asthma because of the vaccine,” DAF-K president Dr Gopal Dabade said. Prevenar is the only licensed…. To read more, click here

To read the open letter sent by DAF-K, click here

Price Control Move Hailed (AIDAN Press Release 2006)

Press Release: 27 July 2006

MOVE TO BRING ESSENTIAL MEDICINES UNDER PRICE CONTROL HAILED

– All India Drug Action Network (AIDAN) calls for a comprehensive, balanced and rational drug policy

The All India Drug Action Network (AIDAN), which is a national network of a number of organisations who have been working on pharmaceutical policy issues since the early eighties, has hailed the decision of the Union Chemicals and Fertilisers Ministry to bring all the medicines in the National List of Essential Medicines under price control.

RATIONALE FOR PRICE CONTROL

We point out that there is a strong rationale for price control of the essential drugs

·    Medicines are the only commodity in which the payer (the patient) does not decide what to buy and at what cost. The doctor prescribes and the patient pays.

·    Unlike other commodities, the purchaser of medicines is extremely vulnerable as they are seeking immediate relief from suffering. Hence even in so-called market economies (except USA) medicine prices are regulated.

·    In India, unlike in the developed countries, expenditure on medicines constitutes a large proportion (>50%) of total medical expenditure. 90% of this expenditure is out-of-pocket expenditure by the people, since the government spends a very small proportion on medicine procurement

·    Unlike in the developed countries, most Indian patients face the drug industry as hapless individuals because most are not covered by insurance or social security mechanisms.

·    Majority of Indians are below or near poverty-line, yet they are forced to spend on unnecessarily costly medicines. This unnecessary expenditure on medicines is a very important cause for indebtedness after hospitalization.

·    The track record of the drug industry in India as regards to pricing is extremely reprehensible. The following example would illustrate this point –

The same drug in the same strength manufactured by two trusted companies can vary from 2 times to 20 times in their prices, which has no credible explanation other than overpricing. Levofloxacin used in infections is sold by CIPLA at Rs. 7 per tablet, while Aventis sells it at Rs. 95 per tablet. What is worse is that costlier drugs most often sell more because of more aggressive promotion.

·    Lastly, the prices of drugs outside price control are marked by anarchy and price deregulation in the past has increased the prices of drugs. Committees constituted by the Government have clearly documented abnormal rises in prices of drugs after they were taken off the list of price-controlled drugs. For instance –

After price deregulation in 1995, the price of some TB drugs rose by 250%. Yet no action has been taken.

Successive governments had brought down the number of drugs under price control from 347 in 1977 to a projected 25 or so in 2002, due to industry pressure. And it took the Supreme Court of India to take note of the situation and rule that, this would make them out of the reach of ordinary people.

PROFITABILITY vs. PROFITEERING

We believe that ‘price regulation is fully compatible with profitability’, as the real cost of manufacturing a drug is often a very small fraction of the retail price. For instance, Cadila Pharmaceuticals bid for supply of a medicine for worms, Albendazole 400 mg tablets, at a mere 22 paise, while its ZYBEND brand sells for Rs. 11.90 in the market. A drug for hypertension like Atenolol is procured at 12 paise by Delhi State while in the market, the same drug is sold for as much as Rs. 2.50, i.e. over 20 times the cost.

Currently drug prices are unnecessarily high also because the pharma trade too is indulging in profiteering. The trade margins in pharmaceuticals can be astronomical. A study done by VOICE, a consumer education organisation, and supported by the National Pharmaceutical Pricing Authority had shown that the difference in price to the retailer and that to the patient could well be over 400%. For instance, Nimesulide was available at Rs.24 for 10 tablets, while the price to the retailer was just Rs.6 for the same. The trade margin should also be regulated.

Pharmaceutical sector needed to explain to the public how it could afford to sell drugs at even 10% of their MRP to wholesalers and not suffer from loss of profitability and yet complain bitterly whenever the MRP was sought to be lowered by the government? The proposed pricing policy talks of a 150-200% margin on the post-manufacturing expenses for drugs under price control. Surely such a profit margin was adequate for profitability of any manufacturing enterprise,

RESEARCH vs. MARKETING

We disagree with the claims of the drug industry that research would be hit due to price control. In India, pharma companies spend 2% of sales on research and ten times on sales promotion! Pharma industry should divert its expenses from unnecessary sales promotion to research. It has been a part of the pharma policy that any drug developed by indigenous R&D shall be exempt from price control for a period of up to 15 years. But, here have been no claimants!

MORE ACTION REQUIRED

Past experience suggests that in the light of price regulation, the companies switch to production and promotion of alternative drugs, which are often irrational or higher priced alternatives which are outside the list. The government should pre-empt this by bringing all alternative drugs also under price control, if not, at the very least, under a scheme of price monitoring. And with over 649 million people in India lacking regular access to essential medicines (World Medicines Situation Report, 2004; WHO), there is an urgent need to go beyond just price control and to institute a comprehensive, balanced and rational drug policy in the country.