AI, HEALTH CARE AND LAW: PART 1 - The Daily Guardian
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AI, HEALTH CARE AND LAW: PART 1

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International Law and Health Related International Standard Setting Instruments play an important role in evolution and development of International Health Law. Conventional International Law is the primary International Legal Instrument through which International Organisations can extend International Cooperation for improving the Global Health Status as also reducing the Global Burden of Diseases. In the recent times, there has been an increase in the Inter-Governmental Organisations in the domain of Health Care. Let us take the instance of the growing diversity of International Law relating to Public Health wherein a broad array of Inter-Governmental Organisations including United Nations and its agencies and other related bodies are contributing to the development of International Health Law. The International Health Law is therefore emerging in a fragmented and amorphous manner.

AI is having huge impact on Health Care and is transforming the Health Care Economy. AI has been defined as “the Development of Computers to engage Human Like thought processes such as Learning, Reasoning and Self-Correction”. While Machine Learning is a field of AI and in the context of Health Care has been put to varied uses ranging from classifying Health Care Data, to Diagnostic, Disease Predictions. Application of AI in Health Care can be broadly classified into:

• AI and Patient Care

• AI and Clinical Practice

• AI and Administration and Operations

• AI and Medical Research and Development

The International Health Law is a proliferation of multilateral organisations that often raise over lapping legal authority issues. However, International Health Law consolidates international standard setting instruments along with health-related legal rules, norms, and standards. The International Human Rights Law also plays an important role in International Health Law given the fact that right to health is also a significant human rights norm. While it can be argued that right to health features as a core parameter in the context of International Health Law since it emphasizes on the protection individual health care world-wide and strives for equity in health. The development of International Health Law in the context of AI also largely is an interplay of Privacy Laws, Cyber Laws, Cyber Security Laws, Civil Laws, Criminal Laws, Tort Laws, Medical & Health Laws.

AI primarily relies on data and data sets and makes use of the techniques like machine learning and natural language processing. AI is enabling better Health Care and Governance by analysing the Health Data in a precise and quick manner for a better detection, diagnosis, and treatment. AI driven technologies by way algorithms, facial recognition, chatbots bring forward various legal, regulatory, ethical and medico legal considerations when applied in the context of Health Care. The primary regulatory issue with regard to AI in Health Care is the archaic regulatory infrastructure.

Given the fact that AI is making use of machine learning techniques & the constant learning capabilities, AI algorithms keep evolving and by the time the regulatory approval is granted, the learning capacities of algorithms are increased making them entirely different.

Further, another aspect of AI is the black box, while we will be able to program an AI algorithm, but we do not have any clue how it works inside, this brings an issue of explicability and therefore making the regulatory challenges unique.

AI, HEALTH CARE AND LEGAL ASPECTS

• PRIVACY

Many AI systems collect, store, process transmit, huge amounts of data of which sensitive and personal data are an essential component. AI in the context of Health Care primarily handles a lot of personal data relating to the patients including electronic health & medical records, diagnostic reports, medical conditions, medical history, vitals related information, information relating to height, weight, Body Mass Index (BMI), psychological & human behaviour patterns. Various International, National, Federal, and state rules and common laws govern the collection, processing, handling, transmission of such personal data. While in the context protection of patient’s privacy assumes a lot of significance.

It is very interesting to understand if the outcome predicted by an AI algorithm consisting of any personal data of the patient amounts to privacy breach given the complexities of AI algorithms. Is the privacy of the patient protected adequately by AI algorithm is another question?

Further, in case of AI based Chatbots in the context of health care, the following privacy considerations are likely to arise. Is the chatbot authorised to collect personal data of patients? What is the legal status of the AI based Chatbots? Some limited amount of legal recognition shall be required to answer questions like this.

• INFORMED CONSENT

The AI Algorithms often make use of personal data of patients in the context of health care be it for analysis, predictions, counselling prescribing medicines and treatments, therapeutic sessions, and other areas. In the context of machine learning the clinical data of the patient is used for developing Algorithms for improvement of health care and for research and development activities. Initially the patients may provide informed and free consent with regard to collection, processing, sharing their sensitive and personal data specific for better diagnosis of their health and medical conditions. However, this becomes a challenge in case of large data sets. However, seeking Informed Consent shall be difficult in case of providing fine print terms and conditions in a manner not specifying about the future uses of the data. However, it may not be viable to seek Informed Consent at every stage where the Patients data is used given the kinds of complexity in which the AI Algorithms operate.

However, using the opt in and optout models may not be workable in the context of Al Algorithms as the AI Algorithms make use of machine learning and become more and more intelligent. It may not be possible to predict how and the manner in which the personal data possessed by the AI Algorithm is used. Informed Consent in the context of AI in health care becomes very important since the patient is required to be informed about the different options regarding his health and medical conditions and he is the decision maker with regard to the same. AI Algorithm must be designed in a manner to seek Informed Consent in a reasonable manner making the Patient aware of the different options and enabling them to choose thereof. There are however different kinds of approaches, different Jurisdictions, which have an emphasis on either patient or doctor’s role with regard to consent in a reasonable manner to determine the ground for baseline.

• DATA PROTECTION

One of the biggest limitations of AI in health care is involvement of machine learning and deep learning approaches which require huge amount of data sets for the purpose of analysing, testing, and predicting. These large sets of data definitely comprise of sensitive and personal data of patients including their health-related information, medical related information, personal information, and others. Removing all potentially identifiable- information from these data sets can be a herculean task. In this scenario, data protection assumes a greater significance. It may also be possible to identify individuals by linkage with other data sets even if the data sets are not including any medical images or medical related information or do not make use of any advanced or future technologies. Data sharing becomes another important aspect that requires legal considerations in the context of AI and health care. Data sharing involves sharing of sensitive and medical data which may increase the risk of data breaches.

However, having restrictive data sharing arrangements can reduce the widest possible patient benefit. It is advised that new regulations governing privacy must be created in the context of AI and health care to protect the sensitive and personal data of patients against inappropriate usage, accidental disclosures, and weakness in deidentification techniques. However, over protection of personal data may be detrimental to data driven technologies like AI. However, a balance needs to be struck between the adoptive technology and data protection.

• INTELLECTUAL PROPERTY RIGHTS (IPR)

AI Algorithms largely are largely associated with data and data sets. In the context of AI in health care AI Algorithms possess large chunks of data which are created which are a result of using analysis and correlation of human created works. In this kind of scenario lots of Intellectual Property is created out of such Algorithms. In addition to the above, the AI Algorithms making use of machine learning and deep learning techniques, analyse and predict new outcomes which also are capable of being considered as Intellectual Property.

The Ownership of Intellectual Property rights in respect to the data possessed by the AI Algorithms assumes significance. Considering the fact that the creators and developers become the first owners of intellectual property. In this context, copyright becomes an important element with regard to protection of such data and data sets

Another aspect of intellectual property in the context of AI in health care is the analysis and predictions and outcomes generated by AI Algorithms. Are the machines capable of protecting the Intellectual Property created out of its Algorithms? Can an AI system license its Intellectual Property? This question becomes significant in the context of AI in health care in case AI is leveraged by various stake holders in the health care industry.

Let us take an example, in case, a doctor engaged by a hospital makes use of AI for the purpose of analysing the medical and health condition of a patient who owns the Intellectual Property of the output generated by the Algorithm.

In case an AI Algorithm comes up with unique invention or discovery in the field of health care subject to its analysis using the data through machine learning and deep learning, can such inventions be capable forgetting Patent protection? This becomes important since AI in health care is leveraged for research and development and further analysis.

In case of any data or datasets possessed by AI and Algorithm are copyrighted material, the legal accountability for IP related infringements will also have to analysed.

The International Health Law is a proliferation of multilateral organisations that often raise overlapping legal authority issues. However, International Health Law consolidates international standard setting instruments along with health-related legal rules, norms, and standards. The International Human Rights Law also plays an important role in International Health Law given the fact that right to health is also a significant human rights norm. While it can be argued that right to health features as a core parameter in the context of International Health Law since it emphasizes on the protection individual health care world-wide and strives for equity in health.

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‘If you want a change, choose me’ : Tharoor on Congress president poll

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Shashi Tharoor claims party's support

In the upcoming presidential election of the grand old party, Congress leader Shashi Tharoor reiterated on Saturday that his contest against senior party member Mallikarjun Kharge “is not a battle.” Following days of turmoil surrounding the intra-party troubles in Rajasthan, Tharoor and Kharge finally submitted their nominations for the crucial elections, which are set for October 17, on Friday.

“This is not a war. We can belong to different schools of thoughts. Let the members decide,” Tharoor told news agency ANI in an interview on Saturday. “All I am telling the members is  that if you’re satisfied with the functioning of the party, please vote for Kharge Sahab. But if you want a change, choose me.. If you want the party to function differently.”

His remarks came as news spread that the Gandhis were endorsing the 80-year-old Kharge for the top party position. On Saturday, Kharge announced his resignation as the opposition leader in the Rajya Sabha, a day after more than 30 leaders surprised many by end-of-nomination support for his candidacy. In contrast, Tharoor was not accompanied by as many senior leaders.

“But there is no ideological problem here. Whatever the message has so far of the Congress will continue to remain,” Shashi Tharoor said on Saturday, dismissing any differences.

Even though the Gandhis made it clear that they would no longer be running for president post, their management has continued to draw criticism. Regarding the family’s importance for the party in light of the BJP’s dynastic politics allegations.

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Kharge resigns as Rajya Sabha Lop, following ‘one person, one post’ formula

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Senior Congress leader Mallikarjun Kharge submitted his resignation as Leader of the Opposition in the Upper House as he filed his nomination for the party’s chief post, after the Udaipur announcement of “one person, one post.”

“I hereby tender my resignation from the post of Leader of Opposition, Rajya Sabha, consequent upon my filing of nomination for the post of President, All India Congress Committee,” Kharge said in his letter to interim party president Sonia Gandhi.

In February 2021, Kharge took over as the Leader of the Opposition in the Upper House following Ghulam Nabi Azad’s retirement. If Kharge, who is considered to be the front-runner, is chosen as the party president, the Congress may need to find a new LoP in the Rajya Sabha.

Although the selection process for Kharge’s replacement won’t begin until the results are announced, party leaders said that Digivjaya Singh, Mukul Wasnik, or Ranjit Ranjan may be possible candidates.

According to party insiders, Singh, who opted out of the race to support Kharge, might emerge as a possible successor to Kharge. “He doesn’t hold any organisational position and a leader from the Hindi belt can also act like a balancing factor,” said a leader, adding that senior party leader Mukul Wasnik may also be considered. Among women leaders, Ranjit Ranjan, a fierce orator from Bihar, or Gujarat’s former leader of the Opposition Shakti Sinh Gohil could also be considered, said a Congress leader from Rajya Sabha.

In an April 2022 decision, the Udaipur Chintan Shivir demanded that the policy be put into effect at all party levels.

Ashok Gehlot, the chief minister of Rajasthan, decided not to run for president of the Congress after Rahul Gandhi’s strongly advocated “one person, one post” formula sparked an uprising inside the state party last week. A majority of Congress MLAs in Rajasthan staged a separate meeting and prevented the adoption of a one-line resolution authorising the party leader to propose Gehlot’s replacement.

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As ‘Bharat Jodo’ enters Karnataka, rattled BJP gives front-page ad that distorts history: Jairam Ramesh

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As Rahul Gandhi’s Bharat Jodo Yatra entered the BJP-ruled state, according to Congress leader Jairam Ramesh on Saturday, the BJP placed a front page advertisement in a Kannada newspaper. Ramesh said in a tweet, “The advertisement mischievously distorts history as usual. Savarkar propounded two-nation theory & Jinnah ensured it got done. Syama Prasad Mukherjee, founder of Jan Sangh championed partition of Bengal.” BJP is rattled by the yatra’s success, the Congress leader continued.

The Bharat Jodo Yatra of Rahul Gandhi entered the election-bound state of Karnataka on Friday. There, the yatra will travel 511 kilometres across seven districts in 21 days.

Rahul Gandhi remarked in a statement at the beginning of the march’s Kerala leg that the Bharat Jodo Yatra is the voice of the nation and that no one can stop it.

“Entire control is lying with the (Central) government. If we speak in Parliament, they shut our microphones,” Rahul Gandhi said.

A new Rahul Gandhi and a new Congress party have emerged from the Bharat Jodo Yatra which forced the BJP and the RSS on the backfoot, Jairam Ramesh said on Friday. “People asked who is ‘thodoing’ (breaking) Bharat for Congress to do Bharat Jodo, our answer is Mr Modi’s ideology, policies, personality is thodoing Bharat. Because economic inequality is increasing, social polarisation is increasing and political over-centralisation is increasing, the Congress is doing this yatra,” Jairam Ramesh said.

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Rajnath Singh Urges Industry cooperation to take Indian defence sector to new heights

Government Steps to Improve Defence Industry manufacturing eco system are showing results: RM

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Rajnath Singh

Introduction
Defence Minister Rajnath Singh exhorted the Indian defence Industry to make new investments and lay more emphasis on research & development to scale new heights. He was addressing the 117th Annual session of PHD Chamber of Commerce & Industry (PHD-CCI ) held in New Delhi on September 30th, 2022. “Make new investments, put more emphasis on research & development, and harness its full potential to take the Indian defence industry to new heights. This effort of yours will be very important not only for the defence industry, but also for the overall growth of the entire country,’ he said.
Raksha Mantri added that the Indian defence sector offers immense potential and the companies even from abroad see opportunities. PHD-CCI being one of the oldest industry associations having many national and international members could act as ambassador of the Indian defence industry. “Your roots are spread far and wide in the country and abroad. You can fulfil your role by communicating with all the domestic and foreign companies, connecting them with the Indian defence industry and acting as a bridge between these two,” he said
Appreciating the PHD-CCI for scheduling a dedicated session on ‘Make in India: A success story of India’s Defence Indigenization’ Raksha Mantri said that this is equally related to the national security, and the economic progress of the country. National security is one of the most important components in the progress of a nation. The social, economic and cultural upliftment of the nation are not possible without security.. India had paid the price in past for neglecting national security. Even after independence not enough attention was given to make defence sector strong and self-reliant, he lamented.
Striking an optimistic note, Raksha Mantri said that Indian defence industry is progressing steadily in partnership with private sector.”There was either no way for the private sector in the past to enter the defence sector, and even if there was some scope, the industry was not ready to set foot in the defence sector due to various reasons”. These reasons were lack of political will, appropriate policy to incentivize their entry, high investment and long gestation period.
Raksha Mantri noted that the government has removed these bottlenecks and played the role of an incubator, catalyst, consumer and facilitator in the case of private industry. Several steps have been taken by the Ministry of Defence, under the ‘Make in India’ and ‘Self-reliant India’ initiatives of the Government, to change the old traditions, and to create a manufacturing climate, in which the public and private sectors could participate.
Elaborating upon the far-reaching reforms undertaken by the MOD to bolster the private sector participation in defence sector, Raksha Mantri said that Government labs opened to the private industry, transferred technology at zero fee, provided access to test facilities, and upfront funding through DRDO was provisioned.
The Ministry of Defence has issued 3 positive indigenization lists of 309 items which will be procured from domestic vendors as per norms. Three lists have also been issued by Defence Public Sector Undertakings (DPSU), in which more than 3700 are Line Replacement Units, Sub-systems and other Components. In addition, an iDEX initiative has been launched to encourage innovators and start-ups. The policy decision has been taken to increase the limit of FDI to 74% by the automatic route, and to 100% by the government route in special cases. Government has taken several steps like introduction of defence industrial corridors– two Industrial corridors have been set up each in Uttar Pradesh and Tamil Nadu, corporatization of OFB which creates win-win situation for armed forces, industry, start-ups and innovators, said Raksha Mantri.
He further said : “The magnitude of all these efforts is beginning to come before us. Today we are not only producing to meet our own defence needs, but also fulfilling the defence needs of many other countries under ‘Make for the World’. It is a matter of great happiness that defence exports have increased manifold from what we used to have, and have reached Rs 13,000 crores last year. We used to be counted as one of the biggest arms importers in the world until now. But today we are one of the top 25 arms exporting countries of the world. We have targeted a turnover of Rs 1.75 lakh crore in defence manufacturing, including Rs 35,000 crore from exports in aerospace, and defence goods and services by 2025.”
PHD-CCI is one of the oldest chambers in the country. Since its establishment in 1905, it has been proactive National Apex Chamber working at the grass-root level and with strong national and international linkages. The Chamber acts as a catalyst in the promotion of industry, trade and entrepreneurship. PHD Chamber, through its research-based policy advocacy role, positively impacts the economic growth and development of the nation.

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Indian Railways to release its new All India Railway time table

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Indian Railways to release its new All India Railway time table

The Ministry of Railways will be releasing its new All India Railway Time Table known as “TRAINS AT A GLANCE (TAG)” effective from 1st October, 2022. The new Trains at a Glance will also be available w.e.f. 1st October, 2022 on Indian Railways’ official website i.e. www.indianrailways.gov.in.

Highlights of the new time table are as follows:
I. Indian Railways runs about 3,240 Mail/Express trains which include Vande Bharat Express, Gatimaan Express, Rajdhani Express, Shatabdi Express, Humsaafar Express, Tejas Express, Duronto Express, Antyodaya Express, Garib Rath Express, Sampark Kranti Express, Yuva Express, Uday Express, Janshatabdi Express and other types of trains. In addition, about 3,000 Passenger trains and 5,660 suburban trains are also operated over the Indian Railways network. The volume of passengers carried daily is about 2.23 Crore.
II. To clear extra rush and meet passenger demand, more than 65,000 Special train trips were operated during 2021-22. About 566 coaches were permanently augmented to increase the carrying capacity.
III. Maximize the utilization of rolling stock:
i. During review of the lie over of rakes it was observed that the rakes can be better utilized for extending the existing services or increasing the frequency. This would maximize the utilization of the rolling stock and provide better connectivity to the travelling passengers.
ii.During the year 2021-22, 106 new services were introduced, 212 services were extended and frequency of 24 services was increased.
IV. Proliferation of Premium Trains:
i. At present, Vande Bharat Express trains are operating between New Delhi – Varanasi and New Delhi – Shri Mata Vaishno Devi Katra. One more Vande Bharat Express train has been introduced between Gandhinagar Capital and Mumbai Central w.e.f. 30.09.2022. It has been proposed to introduce more Vande Bharat Express trains over the Indian Railways network.
ii. Tejas Express services offering onboard services like entertainment, local cuisine, wifi etc. are also being proliferated over Indian Railway network. At present, 7 pairs of Tejas Express services are operational over Indian Railways.
V. Provision of Corridor Blocks in the working Time-Table of the divisions:
To provide sufficient time for the maintenance of the fixed infrastructure like track structure, signaling gears, overhead equipments, it has been planned to ensure provision of fixed corridor blocks. The duration of these corridors blocks will be from 3 hours in each section. This will not only improve the reliability of the assets but also enhance the passenger safety.
X. Conversion of Rakes ICF to LHB:
The conversion of Mail/Express trains operating with ICF design rakes is being undertaken to improve passenger safety and provide faster transit with better riding comfort. Indian Railways converted 187 Rakes of ICF to LHB for the period of 2021-2022.
VII. Efforts to improve punctuality of late running trains:
Necessary changes in the time table have been incorporated to improve punctuality. Due to concerted efforts the punctuality of Mail/Express trains has improved by about 9% as compared to the punctuality during pre Covid (2019-20).
viii. Standardization of rakes:
The rakes at different maintenance depots have been standardized by integration of the rake links to improve flexibility in operations and thereby help in improving punctuality.
IX. Replacement of conventional Passenger trains with MEMU/DEMU:
In the year 2021-22, 60 number of conventional passenger services have been replaced by MEMUs thereby increasing the overall mobility of the system.
X. Availability of Trains at a Glance as “e-Book”:
As a part of digitalization of train Time Table, Trains at a Glance (TAG) will now also be available as ‘e-Book’ which can be downloaded from IRCTC website (www.irctc.co.in & www.irctctourism.com).

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Strict Action against defaulters: Union Environment Minister Bhupendra Yadav

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Strict Action against defaulters: Union Environment Minister Bhupendra Yadav

Union Minister of Environment, Forest & Climate Change, Bhupender Yadav, conducted a detailed review on 30.09.2022 on measures and actions planned towards abatement of air pollution by all stakeholders concerned in the National Capital Region and adjoining areas, in the wake of poor air quality conditions generally prevailing during the period between October – January each year,
Union Minister impressed upon key sectors that contribute to air pollution and are critical in the ensuing 3-4 months period. He emphasized that source of air pollution such as paddy stubble burning, open biomass / municipal solid waste burning, industrial emissions and particulate matter / dust emissions from construction / demolition activities and roads / open areas were directed to be focussed for concerted preventive and mitigative actions.
Union Minister directed for timely and effective implementation of various components of the detailed plan of actions, developed by the NCR States and Punjab, pursuant to CAQM Framework / Directions on management of paddy stubble burning. Secretary, Ministry of Environment, Forest & Climate Change called upon Punjab to expand the coverage of area under Bio-Decomposer through pro-active action by the State Government specially since a very marginal increase had been proposed in the coverage of area under Bio-Decomposer i.e. form 7500 acres in 2021 to merely 8000 acres in 2022.
Chairman, CAQM also emphasized the need of time bound implementation of the action plan particularly by the State of Punjab. Optimal utilisation of available crop residue management machinery with the states was identified as a key factor towards effective management of stubble. Extensive use of technology and mobile applications for mapping the demand and supply of such CRM machinery through the CHCs and cooperatives was emphasised upon during the meeting. It was also stressed upon enhancing the net of PUSA bio‑decomposer application for in-situ management of the stubble. Towards ex-situ utilisation of paddy straw various options are now being progressed with including biomass power generation, bio-ethanol production, CBG production, co-firing in thermal power plants, fuel for industrial boilers and other misc. applications, composting, cattle fodder and misc. commercial applications in furnishing materials and packaging etc. Progress on co-firing of biomass in thermal power plants has not been up to the desired levels and the Minister called for immediate corrective measures by Thermal Power Plants to substantially enhance co-firing. The Minister asked CAQM to utilize his statutory powers to take action against the defaulting the Power plants and also any other defaulting entities.
Union Minister expressed his concern and dis-satisfaction with the preparedness of Punjab in taking concrete action on the ground towards Air Quality Management while pointing out that the State Government had not planned adequately for management of almost 5.75 million tons of stubble which is a huge gap and was likely to have an adverse impact on the air quality in Delhi and NCR region.
The Minister exhorted the need to switch over to clean fuels for industrial applications and directed for a quick transition to clean fuels as per the approved standard fuel list for NCR as directed for by the CAQM. Controlling heavy pollution from a large number of diesel generator sets operating in NCR was also identified as key action area and the Minister emphasised on strict implementation of restrictions on use of DG Sets and emission control measures in this context.
The review highlighted the need for effective dust control measures in various anthropogenic activities, construction / demolition activities, roads and open areas. Effective utilisation and augmentation of mechanised road cleaning equipment, water sprinklers and anti-smog guns by NCR State Governments / GNCTD was also emphasized during the meeting.
Considering the criticality of air pollution related mattes including the weather conditions around Diwali festival, the Minister directed for special and timely measures to control the air pollution levels.
As air pollution in the region is a multi-dimensional and multi-sectoral phenomenon, spreading across geographical boundaries, the Minister reiterated the need for collective and concerted efforts of all the stakeholder agencies, departments in the State Govts. and public at large towards abatement of air pollution in the region and to this effect directed that all directions, orders and guidelines of the CAQM / CPCB/ State Pollution Control Boards be implemented in right earnest and critically monitored / reviewed periodically by the authorities concerned.
Senior officials from the Ministry of Environment, Forest and Climate Change including Secretary, Chairman, Commission for Air Quality Management (CAQM), Secretary in-charge in the State Govts. of Punjab, Haryana, UP and GNCT of Delhi, Chairman, Central Pollution Control Board, NCR State Pollution Control Boards, DPCC and other major stakeholders participated in the review meet.

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