Workshop report | Provocations on AI Sovereignty: Confronting Complexities & Shaping Future Strategies

By Urvashi Aneja, Harleen Kaur, Shreeja Sen and Anushka Jain

Developed from reflections from the workshop, this report explores what digital sovereignty means, assesses its feasibility, examines who benefits from such an agenda, and unpacks the new policy conundrums it raises.

The concept that every country should develop its own AI capabilities is gathering steam globally. Several countries are investing in specialised computational infrastructure and developing national data sovereignty frameworks to ensure their strategic and economic self-reliance.

Yet, the AI sovereignty discourse obscures the substantive political choices that become necessary once the agenda is translated into concrete policy actions.

We need to ask for whom and from whom sovereignty is to be won—does it pit nation-states against one another, or is it about empowering citizens vis-à-vis powerful technology companies?

Equally, is it about boosting a country’s competitiveness in the global AI race or carving out policy space to pursue goals that might lie outside those pursued in the dominant AI paradigm?

With support from Samagata Foundation, in November 2024, we hosted a workshop to explore the debate around AI sovereignty and its implications for India. Along with 18 of the country’s leading thinkers and practitioners, this workshop created a space for first-principles thinking and forward-looking debate through in-depth discussions.

Read the report here.

Publication | Legal and regulatory framework for laboratory testing in India: A case study for Covid-19

By Harleen Kaur, Ameya Paleja, and Siddhartha Srivastava.

Testing is central to understanding the spread of the SARS-CoV-2 virus at an individual & population level and designing suitable interventions (Shah, 2020). As of June 23, 2020, India has the fourth-largest number of SARS-CoV-2 cases worldwide. This is despite having conducted only 119 tests per million people. In comparison, the United States and Russia, countries with more cases than India, have conducted 1518 and 2074 tests per million, respectively. While India has somewhat improved its testing rate since the early stages of the SARS-CoV-2 pandemic (21 per million on April 24), we are still unable to test in adequate numbers. In this blog, we study the reasons behind insufficient testing rates in India by reviewing the legal environment for regulating medical testing.

The Indian diagnostics industry is dominated by the private sector. The legal framework for the regulation of private labs is set up under the Clinical Establishments Act, 2010. The issues of non-standardisation of service quality and supplier-induced demands are prevalent in the industry (Competition Commission of India, 2018). Therefore, these labs have been functioning under market-led and self-imposed norms. The government did not depend on this regulatory framework during the SARS-CoV-2 pandemic. Instead, it granted unchecked discretionary power to the Indian Council of Medical Research (ICMR) to regulate the testing strategy. Under the regulatory framework set up by the ICMR, the private lab network is not being utilised optimally for SARS-CoV-2 testing. For instance, the private sector accounts for about 70% of the health care market in India. As of June 22, 2020, only 27% of all labs approved for SARS-CoV-2 testing in India are private labs. In this article, we argue that (i) the private labs are governed by a weak regulatory framework that has allowed market failure to persist in the diagnostics sector in India, and ii) the testing strategy mandated by the ICMR for the SARS-CoV-2 pandemic has led to poor outcomes for the participation of private labs. Hence, there is an immediate requirement for reviewing the powers of ICMR for managing the testing strategy and a long-term requirement for rethinking the present regulatory framework for labs.

Concerns about market failure in the field of medical testing

A market failure occurs when the free market is unable to obtain efficient economic outcomes. Of the four types of market failures, viz, externalities, asymmetric information, market power, and public goods, the diagnostics sector in India is seen to be affected primarily by information asymmetry. Information asymmetry or information inequality occurs when one party, such as a physician, possesses much greater information than the other, a patient (Arrow, 1963). During a pandemic, testing becomes a crucial part of a nation's public health strategy, and hence, the public goods element of market failure also comes into play. For instance, testing data is a public good inasmuch as it is useful to understand the spread of the disease in an area that helps the government to design public health policies, and sharing of such data by the government affects behavioral changes in individuals.

As a result of information asymmetry, the field of medical testing in India faces the recurring issue of quality control and standardisation of services. For instance, practices such as hiring unqualified professionals, using sub-standard equipment, and proxy digital signatures have become prevalent in the industry in the absence of effective regulation. In extreme cases, there have been instances of private labs disbursing 300-400 diagnostic reports within a matter of hours, often without conducting any testing at all.

The free market does not solve the issues of market failure on its own and requires state intervention. This can be done through effective regulation of the market, either by itself or through State coercion. We now study the existing regulatory framework for labs in India and its limitations.

Regulation of diagnostic labs

Healthcare is a state subject under the Indian Constitution. This means that in the usual course of events, states have exclusive powers to make laws concerning different aspects of health care, such as diagnostic laboratories. Article 249 of the Constitution provides exceptional powers to the Union government to make laws on state subjects in the national interest. For such matters, the states retain the power to accept or reject the union law. The Clinical Establishment Act has been passed by the Union government under this provision, and 11 states have enacted it as of now. However, there are two difficulties with the law that have created a gap between aspiration and outcome. First, under our constitutional arrangement, the Clinical Establishments Act is only applicable to those states that choose to adopt it, and only 11 states have adopted this law. Second, the law has serious difficulties in design and implementation.

In the 11 states where the Act is present and implemented, the regulatory function is limited to granting registration to labs and maintaining a register of clinical establishments. The labs interact with the regulatory authority only at the time of registration, when they submit evidence of having complied with the prescribed standards for registration to the regulatory authority. Once a permanent registration is granted, there is no mechanism to review the functioning of the labs or provide grievance redressal to patients under the Act. If a person starts a lab without registration, the maximum punishment under the law is a monetary penalty of rupees five lakhs.

Other than the Clinical Establishments Act, private labs have to comply with the standard regulatory requirements under the state Shops and Establishments Act (relating to hours of work, cleanliness, holidays, etc.) and obtain registration under the provisions of the Biomedical Waste Management Rules, 2016. Additionally, diagnostic kits and reagents used by labs are defined as 'drugs' under the Drugs and Cosmetics Act, 1940, and therefore have to be approved by the Central Drugs Standard Control Organisation (CDSCO).

We see that there is effectively no legal framework for regulating private labs in India. The labs only comply with allied regulatory requirements, such as disposal requirements for biomedical waste and approval of diagnostic kits under the Drugs and Cosmetics Act. Given this regime, two mechanisms, namely accreditation and public procurement, have sought to fill the regulatory void in the diagnostics industry.

Alternative methods of regulation

In the absence of an overarching law that assures the quality of clinical establishments, private labs have turned to voluntary accreditation to establish credibility in the vast diagnostics market. Accreditation of labs is not mandatory in India. The National Accreditation Board for Testing and Calibration Laboratories (NABL), an autonomous body under the Quality Council of India, prescribes accreditation criteria for various kinds of labs. Of the estimated 100,000-110,000 labs present in India, around 4000 have NABL accreditation. Some labs prefer obtaining certifications from international accreditation bodies in addition to obtaining NABL accreditation. Accreditation helps in assuring the quality of labs to the public as well as the government.

The second method to ensure quality standards and avoid market failure is public procurement. The government has dealt with the absence of a regulatory framework in the past by using contractual mandates to avail the services of private labs. The standards expected from these labs are contractually specified by the government while entering into public-private partnership (PPP) agreements for diagnostics. For instance, the union government under the National Health Mission (NHM) has a Free Diagnostics Services Initiative, which contains detailed requirements from diagnostic/pathology labs. NABL accreditation is one of the common requirements for private labs to participate in such government programmes.

To compensate for weak regulation under the Clinical Establishments Act, voluntary accreditation by the NABL and public procurement through PPP agreements have acted as alternative strategies for regulation. These alternatives help in reducing information asymmetry and assuring the quality of services to the public and could have played an important part in the regulation of the labs for SARS-CoV-2. Yet, we find that the government strategy for medical labs for SARS-CoV-2 is based on a command-and-control approach under the ICMR.

Regulation of medical labs for SARS-CoV-2

Under the existing regulatory framework, private labs did not have to follow any criteria or adhere to any standards before starting a new/novel test, such as the SARS-CoV-2 test. This means that patients would have been able to get SARS-CoV-2 tests done in any private lab offering the test using reagents/test kits approved by the CDSCO and having a valid bio-waste and other local licenses.

The lack of a regulatory framework led to confusion regarding the role of private labs in the response to the SARS-CoV-2 pandemic. As a result, the government set up an emergency regulatory framework for the SARS-CoV-2 crisis using provisions of the Epidemic Diseases Act, 1987, and the Disaster Management Act, 2005. Using these laws, it appointed the Indian Council of Medical Research (ICMR) as the apex decision-making body for India's diagnostic testing strategy through the MoHFW (see notifications here and here).

The Epidemics Act authorises the state governments to take exceptional measures and prescribe regulations to contain the spread of a dangerous epidemic disease. It lists a set of basic subjects for which regulations may be made such as travel restrictions, examination and quarantine of suspected cases, and inspections of any ship or vessel leaving or arriving at any port of call. The role of the union government under this law is limited to managing epidemic diseases at ports.

The Disaster Management Act contains an administrative framework for disaster management. Section 6 of the Act sets up the National Disaster Management Authority (NDMA) as a nodal body for disaster management. Any directions issued by the NDMA and the union government must be followed by the Union Ministries, State Governments and State Disaster Management Authorities. The SARS-CoV-2 pandemic has been notified as a disaster under this Act. Under this, the government has passed various directives on different aspects of the SARS-CoV-2 response using the umbrella clauses of this legislation such as section 6(2)(i) (The NDMA may lay down the policies, plans and guidelines for disaster management) and Section 10(2)(l) (The National Executive Committee may lay down guidelines or give directions to union ministries, state governments and state authorities for responding to the disaster) have been invoked to respond to the SARS-CoV-2 crisis.

Using the powers granted to it by the government, the ICMR has placed severe restrictions on private labs to test for SARS-CoV-2. These restrictions include requiring approvals from ICMR for lab facilities, commercial testing kits, and cost-capping for testing. We now study the ICMR decisions on testing strategy in detail to understand its role in the testing outcomes for SARS-CoV-2.

The role of the ICMR

The ICMR has been responsible for the regulation of public labs under a 2012 scheme called the Viral Research and Diagnostic Laboratories (VRDL) network under the MoHFW. The scheme was initiated to increase government capacity for the timely detection of emerging/re-emerging viral diseases. The VRDL labs were exclusively responsible for testing in the initial phase of the SARS-CoV-2 pandemic in India.

The initial advisories issued by the ICMR contained no mention of private labs and focused only on directing public labs to undertake SARS-CoV-2 testing. At the time, some state governments explicitly banned private labs from testing as per their regulations issued under section 2 of the Epidemic Diseases Act, 1897. For instance, the Delhi Epidemic Diseases COVID-19 Regulations, 2020 and the Bihar Epidemic Diseases COVID-19 Regulations, 2020 contain the following provision on testing of potential SARS-CoV-2 cases by private laboratories:

"No private laboratory has been authorised to take samples for COVID-19 in the State. All such samples will be collected as per the guidelines of the Government of India..."

Subsequently, the ICMR issued guidelines for private labs to undertake SARS-CoV-2 testing on March 21, 2020. Since then, the ICMR has been responsible for approving private labs to test for SARS-CoV-2. The ICMR conducts checks on the capability of private labs to test for SARS-CoV-2 and updates the list of approved private labs regularly. It also issues detailed guidelines for other aspects of testing such as procurement of reagents, evaluation of commercial testing kits, etc. In doing so, it has usurped the regulatory functions of existing statutory regulators such as the CDSCO, as well as voluntary bodies like the NABL. For instance, while diagnostic kits for SARS-CoV-2 are considered "drugs" and should be approved by the CDSCO, they also require validation by the ICMR. Similarly, NABL approved private labs are required to get a mandatory clearance from ICMR for SARS-CoV-2 testing. This means that while NABL has accredited 278 labs for RT PCR RNA testing for SARS-CoV-2, the ICMR has approved 258 of these labs for testing as of June 21, 2020. The ICMR does not document the rationale or process of performing these regulatory functions. The Epidemics Act and the Disaster Management Act do not require the ICMR to adhere to minimum standards of accountability, transparency, and public engagement. The invocation of these laws to empower the ICMR means that there is no coherent or intellectually defensible framework for reviewing the ICMR's actions during the pandemic except that the basic rule of law principles are followed by it.

Building state capacity for regulation is a gradual process that requires backing by a comprehensive legal framework (Roy et al, 2018). ICMR was abruptly thrust into a role for which it did not have the required organisational or procedural capacity. Hence, it compensated for the lack of a regulatory framework by issuing strict command and control orders. We see that after being appointed as the government regulator for the testing strategy for SARS-CoV-2, the ICMR barred all private labs from testing unless approved by it. Given that the labs are already approved by NABL, the rationale for re-approval for testing of private labs by ICMR was never shared. Additionally, ICMR started regulation of reagents, test-kits and costs of tests. This has had an adverse impact on the testing outcomes as seen below.

Implications of the regulation of private labs by ICMR

ICMR has been responsible for advising on the SARS-CoV-2 testing strategy for the country. The restrictive policies by the ICMR have led to the inaccessibility of the tests for a vast population. As a result, various courts in India are being involved to challenge such policies.

In April, the Supreme court heard the issue of cost-capping of lab testing for SARS-CoV-2 by ICMR and ordered that the tests shall be free for persons falling under government schemes such as Ayushman Bharat or any other category of economically weaker section of the society as notified by the government. The ICMR cost-cap of INR 4500 per test for private labs was not examined by the court in this petition, but it emphasised on the need for affordable tests to the population.

The Delhi high court reviewed the cost fixed by ICMR for the procurement of rapid testing kits in April. It held that the costs at which ICMR procured the kits had an unduly high profit-margin for the vendors and ordered the cost per kits to be reduced from INR 600 to INR 400. Furthermore, the kits procured by ICMR were later found to be faulty. The court criticised the government and ICMR for low testing of SARS-CoV-2 cases in another order dated June 18, 2020. It ordered the government to review ICMR policies on labs such as the protocol for sample collection, approval of labs, data sharing by labs, and costs per test through an existing government committee.

The Gujarat high court is monitoring the state response to SARS-CoV-2 under a suo-motu writ petition. Under this petition, in an order dated May 29, 2020, the court modified the ICMR guidelines on testing for different categories of patients as it found the patient categories to be non-exhaustive. The court has also decided to review the rationale behind the ICMR SARS-CoV-2 testing strategy.

The ICMR has been criticised for its advisories on the evolving SARS-CoV-2 testing strategy by experts. For instance, its restrictions on the usage of RT-PCR and rapid antigen testing are seen to be unreasonable as the testing capacity has been increasing over time. Additionally, the issue of lack of transparency in sharing testing data and its regulatory procedure makes ICMR decisions difficult to understand and implement.

The ICMR policies regarding the testing strategy for SARS-CoV-2 are restrictive for private labs. This is indicative of a trust-deficit between ICMR and the labs. The ICMR regulatory strategy to reduce this trust-deficit is to micromanage every aspect of testing sought to be done by the private labs. This has led to lower participation of such labs in testing for SARS-CoV-2 and issues of unavailability of tests to the public.

Conclusion

The bulk of the health care services in India are provided by the private sector despite the presence of public health care facilities (Hooda, 2015). Recognising the growth and demand of the private sector, the policy framework in health has gradually shifted from the government providing health care services to being a financier of these services (Patnaik et. al, 2018). Recently, the Indian government conceded before the Supreme Court that the testing capacity of the public sector for SARS-CoV-2 is insufficient.

In this article, we studied the regulatory framework with respect to medical laboratories in India. We find that in the regular course of events, the Clinical Establishment Act, 2010, and the rules thereunder are responsible for such regulation. Issues with the adoption and implementation of this Act leave the sector effectively unregulated. Despite the presence of some alternative methods of regulation, the regulatory gap in the diagnostic sector persists. Therefore, there is a need for a comprehensive law to deal with the market failure of information asymmetry and public goods. However, the enactment of such a law is a long-term deliberative process and should not be attempted in the face of a pandemic.

For SARS-CoV-2 testing, the government has deviated from the existing course of minimal intervention in regulating private labs to regulating every aspect of testing through the ICMR. Government laboratories set up under the VRDL framework were initially the exclusive bodies allowed to test for SARS-CoV-2. While private labs have now been allowed to test for SARS-CoV-2, they are still heavily regulated by the ICMR. The rationale for this approach has not been provided. We believe such an approach is unsuitable for managing the SARS-CoV-2 pandemic. Using the broad powers given to it, the ICMR has reduced the capacity for testing in India by introducing prescriptive testing guidelines, licensing requirements, and cost-capping. This has resulted in non-utilisation of a bulk of the testing capacity for SARS-CoV-2 in India so far. Therefore, we suggest that the power given to the ICMR for SARS-CoV-2 regulation be minimised by specifically disallowing any duplication of regulatory functions already being performed by bodies such as CDSCO and NABL. Further, for the powers delegated to ICMR for regulating the testing strategy, due process requirements such as documenting the rationale, public consultation, sharing of public data should be mandated by the government to increase the accountability of ICMR.

References and further reading:

Arrow, 1963: Kenneth J. Arrow, Uncertainty and the welfare economics of medical care The American Economic Review, December 1963.

Nandraj, 2012: Sunil Nandraj, Unregulated and Unaccountable: Private Health Providers, Economic and Political Weekly, January, 2012.

Srinivasan, 2013: Sandhya Srinivasan, Clinical Establishments Act, 2010 Regulation and the Medical Profession, Economic and Political Weekly, 19 January, 2013.

Hooda, 2015: Shailendra Kumar Hooda, Private Sector in Health Care Delivery Market in India: Structure, Growth and Implications, Institute for Studies in Industrial Development, Working Paper 185, December, 2015.

Patnaik et. al, 2018: Ila Patnaik, Shubho Roy, and Ajay Shah, The rise of government funded health insurance in India, NIPFP Working Paper Series, No. 231, 21 May 2018.

Roy et al, 2018: Shubho Roy, Ajay Shah, B. N. Srikrishna, and Somasekhar Sundaresan, Building State capacity for regulation in India NIPFP Working Paper Series, No. 237, 3 August, 2018.

Competition Commission of India, 2018, Policy Note: Making markets work for affordable health care, Competition Commission of India, October, 2018.

Kelkar and Shah, 2019: Vijay Kelkar and Ajay Shah, In service of the Republic: The Art and Science of Economic Policy, Penguin Allen lane, December 2019.

Shah, 2020: Ajay Shah, More testing: From concept to implementation, The Leap Blog, 06 April, 2020.

Originally published here.

Ameya Paleja is a molecular biologist and science blogger based in Hyderabad. Harleen and Siddhartha are researchers at NIPFP. The authors are thankful to Ajay Shah, Renuka Sane, Amrita Agarwal, Smriti Parsheera, Shubho Roy, Anand Prakash, Arjun Sinha, and three anonymous referees for their valuable comments.

Publication | Financing Common Goods for Health: A Public Administration Perspective from India

By Ajay Shah, Sanhita Sapatnekar, Harleen Kaur, and Shubho Roy

On average, higher per capita GDP is correlated with improved health outcomes. In parallel, improved population health also seems to foster higher GDP. Yet health and growth need not increase proportionately with one another, nor is this relationship universal. Patnaik highlights potential externalities resulting from growth that could negate efforts to improve population health: development itself can both increase and decrease certain health risks depending on how the process is planned, implemented, and regulated.

Over the last 35 years, India’s GDP grew annually at 6.3% (doubling every 11 years or so) but population-based health indicators did not improve proportionally. Instead, new health risks emerged while old ones remained unresolved. Decades of rapid urbanization led to unsafe buildings, unplanned cities, bad drainage and sewage, dysfunctional garbage disposal systems, polluted air and water, among other issues. For example, with the construction of roads catering to high-speed traffic, accompanied by inadequate design of road safety systems, road accident fatalities have surged since 1999.

Today, India’s disease burden is evolving into two streams. The first is the persistent poverty-related health agenda (e.g., malnutrition or high infant and maternal mortality). The second relates to growth that does not consider new health risks emerging from it (e.g,. air pollution resulting from rapid urbanization or infrastructure built on areas prone to natural disasters). In both areas, the key policy response involves population-based government-financed interventions that generate large societal health benefits, i.e., Common Goods for Health (CGH). Moving forward, CGH is therefore at the center of Indian health policy. In this commentary, we draw on India’s experience to decompose the overall CGH agenda and identify common obstacles that countries may face in financing such goods.

You can read the whole article here.

Publication | The dilemma of Indian health policy landscape

By Harleen Kaur and Dr. Suresh K. Rathi

A health policy aims to achieve specific health goals for a society. According to the World Health Organization, an explicit health policy can achieve several things, amongst them; define a vision for the future, which in turn helps to establish targets and points of reference for the short and medium term, and outline priorities, expected roles of different groups, build consensus and informs people.

India has seen three National level Health Policy documents till date. These documents were released in 1983, 2002 and 2017 respectively by the Ministry of Health and Family Welfare. As they are too few and too far in-between, they are not the only drivers of policy action in the field. Attributing to the nature of public health and also India being a diverse country, our public health issues originate at various quarters which have direct or indirect effects on health. For instance, the dichotomy of double burden of diseases which causes harm to the rich and poor sections of society; lack of governance and proper implementation of regulations for doctors; road accidents and violence. Another factor that makes the Indian landscape complex is the interdisciplinary nature of most of health related issues. Even though the National Health Policies try to measure these risks and provide for a mechanism to prioritize them, they fall short of being comprehensive.  

Other factors influencing health policy decisions in India:

NITI Aayog: Since the Planning Commission was discontinued and the National Institution for Transforming India (NITI Aayog) formed in 2015, there have been a considerable number of health-related policy decisions directed by the NITI Aayog. For instance, the three-year action agenda lists priorities of the NITI Aayog which are not entirely in line with the recent National Health Policy (2017).

Other central ministries: In the recent past, the Ministry of Women and Child Development (WCD) has been seen to take interest in policy decisions like the Integrated Child Development Services (ICDS). Similarly, the Ministry of Environment, Forests and Climate Change is in charge of public goods that have a direct effect on public health and is struggling with control of air and water pollution in the country. The Ministry of AYUSH is perhaps the most closely related to the health ministry. AYUSH ministry has been pushing for integration of alternative medicine in mainstream as well as has legitimate interests in preventive public health. Similarly, the decisions of the Ministry of Consumer Affairs, Food and Public Distribution and Ministry of Drinking Water and Sanitation have direct impact in health status and health policy of the residents in the country.

State decisions and politics: An interesting aspect of the federal nature of our country is that health policy domain is not entirely state or a central subject. While the state has exclusive control on public health and hospitals, the matters relating to medical education and profession are present in the concurrent list, making both the Centre and State responsible for it. Practically, Central Government has been using its fiscal power to design some health schemes affecting public health for the states, with questionable outcomes. For instance, the Rashtriya Swasthya Bima Yojana (RSBY) is a Centrally sponsored scheme where 75% of money is paid by the Centre and 25% by the states implementing it. This offer is lucrative for states as they get more health outcomes for less than half of estimated costs. However, the scheme is not proved to be successful as of yet as the scientific literature showing that it might not have impact on the necessities of the population the scheme caters to - the Below Poverty Line (BPL) population.

Public Interest Litigation and influence by media: Another driver of health policies in India is the judiciary. Through the Public Interest Litigation (PIL) mechanisms, major policy decisions have been driven by the Supreme Court and the High Courts in India. For instance, recently the Supreme Court of India has passed a judgment allowing passive euthanasia in the country and has also detailed the protocol to be followed by the stakeholders in the process.

While participation of multiple actors in driving health policy is a good sign, we need to be careful of the implications of the same. For better regulation of such situation, the Ministry of Health and Family Welfare needs to take an overall arching- in both advisory as well as implementation of decisions affecting public health so as to be able to make better informed decisions. We suggest that the National Health Policy be released every alternate year, after careful public and stakeholders consultation, in order to have an impact in transforming Health of India.

Read more at Medical Dialogues: Guest Blog : Dilemma of Indian Health Policies https://medicaldialogues.in/dilemma-of-indian-health-policies/

Cipa Novartis fight for Pulmonary disease drug

Cipla approaches government for revocation of five patents held by Novartis:

Cipla Ltd, one of the generic drug makers of India has approached the government to revoke 5 patents held by Novartis, a Swiss drug making company for the drug used to treat chronic obstructive pulmonary disease (COPD) marketed by Novartis as Onbrez (indacaterol).

The Department of Industrial Policy and Promotion (DIPP) has started investigation of this demand. Cipla has alleged the following:

a. That Novartis holds the Patents since 2008, but instead of manufacturing the medicines in India, it has been importing negligible quantity leading to shortage of the same in India.

b. That the import for the year 2013 as declared by Novartis in the Patent office is a meagre 53,844 units which do not satisfy even 4,500 patients annually. The shortage is more than 99.97 per cent

c. That Cipla believes that it has the potential to manufacture adequate quantities of the drug and make the same available in the country.

d. That Cipla estimates more than 15 million Indians are afflicted with the disease

e. That Novartis’ product is over 400 per cent more expensive than Cipla’s product.

Cipla has approached the Government under Section 66 of the Patents Act which is reproduced below:

66. Revocation of patent in public interest.—Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the official Gazette and thereupon the patent shall be deemed to be revoked.

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