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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.

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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.

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

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.