In Re: Distribution of Essential Supplies and Services During Pandemic
The genesis of this suo moto writ petition is an order dated 22 Apr. ’21. The Supreme Court (the “Court”) took note of the unprecedented humanitarian crisis in India, following the Covid-19 pandemic. Notices were issued to the Union of India (“UOI”, interchangeably referred to as the “Central Government”), the State Governments and Union Territories.
The Court noted that that jurisdiction it assumed under Article 32 did not automatically lead to the erosion of a High Court’s jurisdiction under Article 226. Instead, the Court emphasized the importance of Article 226, and how the High Courts may be better equipped to deal with issues within their own States. However, this Court assumed jurisdiction over issues in relation to Covid-19 which traverse beyond state boundaries and affect the entire nation.
The Court clarified that the jurisdiction exercised by it in this matter is merely to “facilitate a dialogue of relevant stakeholders, the UOI, the States and this Court, in light of the pressing humanitarian crisis, and not with a view to usurp the role of the executive and the legislature.”
This bounded-deliberative approach is exercised so that the UOI and States can justify the rationale behind their policy approach which must be bound by the human rights framework which includes the right to life (Article 21) and the right to equality (Article 14) of the Constitution.
Outline of the Disaster Management Act, 2005 (“DMA”)
- The DMA came into effect on 26 Dec. ’05. It provides for the management of disasters and matters connected to such disasters.
- Covid-19 falls under the definition of disaster under section 2 (d) of the DMA.
- Under section 6(2)(i), the National Disaster Management Authority (“NDMA”) issued an order dated 24 Mar. ’20 directing the Ministries, UOI, the States/Union Territories and their authorities to take effective measures to prevent the spread of Covid-19 in India.
- Section 2(e) defines “disaster management” as a “continuous and integrated process of planning, organizing, co-ordinating and implementing measures” in relation to the disaster.
- Section 2 (n) defines a “National Plan” as the plan for disaster management for the whole country.
- Section 3 of the DMA constitutes the NDMA with the Prime Minister as the Chairperson.
- Section 6 lists the powers and functions of the NDMA. Under section 6(2)(b) the NDMA has the power to approve the National Plan.
- Section 11 provides the procedure for drawing up and implementing the National Plan.
- A National Plan includes measures for disaster prevention, mitigation, preparedness and the roles and responsibilities of different Ministries as per section 11 (3).
- A National Plan for India was prepared in 2016 and revised and notified in November 2019. The National Plan, 2019 provides a framework to the Government agencies to deal with different aspects of disaster management.
- Section 11(4) states that the National Plan is to be revised annually to ensure that it is a “dynamic document.”
- Section 12 empowers the NDMA to recommend guidelines for the minimum standard of relief to be provided to persons affected by the disaster.
- The Court suggested that considering the human suffering and loss of livelihood that has accompanied this pandemic, NDMA may consider laying down minimum standards of relief in this regard.
- Section 35 empowers the Central Government to take measures which it deems to be necessary or expedient for the purpose of disaster management.
- Section 35(2)(a) provides for coordination of actions between the Central Government and State Governments and their respective authorities in relation to disaster management.
- Section 35(2)(e) obliges the Central Government to assist and cooperate with the State Governments as requested by them or as deemed appropriate by it.
- Section 36 provides the responsibilities that must be undertaken by the Ministries or Departments of the Central Government.
- Under section 36(f) it is the responsibility of every Ministry/Department of Central Government to aid the State Government in drawing up mitigation, preparedness and response plans, capacity building and other relief measures after the occurrence of a disaster.
- Section 35(g) provides that the Central Government is responsible for making available its resources to the National Executive Committee or a State Executive Committee to transport personnel and relief goods to and from the affected area.
- Sections 35 and 36 were enacted in the spirit of cooperative federalism to ensure that the Central Government can assist and enable the State Governments to effectively tackle the disaster.
- The Central Government is operating under the National Plan and the plan is already in force. The plan deals with “Biological and Public Health Emergencies”.
- The States have their own Disaster Management Plans in place.
- The National Plan does not and cannot contain detailed instructions or specific directions for the day-to-day management of the pandemic by government agencies. Such aspects are kept open for executive decision, in view of the dynamic nature of the disaster in question.
- The Centre relied on a judgment of the three Judge Bench of this Court in Centre for Public Interest Litigation v. Union of India, wherein this Court had noted that there was no need to develop a fresh National Plan under section 11 for Covid-19 since a National Plan was already in place, which was being supplemented by various order and measures taken by the competent authorities.
Submissions by UOI:
- The Central Government explained that it recommended a three-tier system of Covid Care Centers (“CCCs”), Dedicated Covid Health Centers (“DCHCs”) and Dedicated Covid Hospitals (“DCHs”) to the States during the first wave of the Covid-19 pandemic.
- The UOI also provided funds under an emergency response package from the National Health Mission and State Disaster Response Fund for this purpose.
- At present, there are 2,084 DCH (of which 89 are under the Central Government and the remaining are with the States); 4,043 DCHC and 12, 673 CCC. Cumulatively these centers have 18, 52, 265 beds, out of which 4, 68, 974 beds are in DCH.
- Tertiary care hospitals under ESIC, Defence, Railways, paramilitary forces, etc. are being leveraged for case management.
- 3,816 railway coaches have been converted into CCCs.
- The Defence Research & Development Organization (“DRDO”) has also set up large field hospitals with capacities ranging from 1,000 to 10,000 isolation beds.
- Through coordination between Central Government and State Governments, isolation beds (with and without oxygen) were increased to 15.7 lakhs as compared to 10,180 before the first lockdown.
- Similarly, ICU beds were increased to more than 85,000 as compared to 2,168 before the first lockdown.
- The affidavit provided details of the effort taken by the UOI to create projections for each State and communicate it to them.
- The UOI developed an IT module for projections of expected cases based on the on-going case load. These projections were regularly shared in writing with the States, along with reports containing emergency plans.
- Details of meetings conducted by the Prime Minister, the Minister of Health and Family Welfare (“MoHFW”), the Cabinet Secretary, the Secretary and the DGHS were provided.
- Details of letters (which seem to have been sent monthly) sent by the Centre to the State indicate that they informed hey State Governments of the projected cases for the coming months along with the number of Oxygen Supported Beds, ICU Beds and ventilators that would be required to manage the case load.
In relation to the preparedness for the second wave of the Covid-19 pandemic, the affidavits state that:
- The Centre has been consistently writing to the States from 4 Dec. ’20 with numbers of projected cases along with the directions requiring them to arrange the necessary infrastructure.
- The State Governments were requested by the UOI to formulate a comprehensive plan in relation to bed capacities, deployment of HR training for doctors and nurses, suitable initiatives for testing, surveillance and risk communication and sufficient referral linkages for districts with deficit infrastructure.
- On 20 Apr. ’21, the MoHFW wrote to the State Governments with their projections and reminded them of the funding avenues available to all States under NHM funding, State Disaster Response Fund and other initiatives.
- The Centre developed a live portal with all the States and districts where they were asked to feed in their data of cases and details such as people under home isolation, on isolation beds and on ICU beds.
- The Centre alleged that the States did not upload their data regularly.
- Additionally, there was a Facility App which could be used by Covid Health Facilities to monitor their patients and the availability of logistics with their health facility. However, the States did not use this app.
National Policy for Admission in Hospitals:
- This Court took note of the fact that, based on the affidavits submitted by the UOI and the hearings that followed, there is no national policy on how admissions must take place in the three-tiers of hospitals namely, the CCCs, the DCHCs and the DCHs.
- Gaining admission into a hospital with a bed has emerged as one of the biggest challenges facing patients during the second wave of the Covid-19 pandemic.
- The Court directed the Centre to frame a National Policy in this regard, in exercise of its statutory powers under the DMA. The Policy should address the following issues:
- No requirement for a positive test for Covid-19 virus considering the immense backlog of testing, the inordinately long wait for the test results and the fact that the new strain of Covid-19 virus is not being detected by a regular RT-PCR test.
- Arbitrary rules for admission to hospitals must be removed.
- No hospital should be allowed to deny a patient admission solely because the patient has travelled from a different State to receive treatment. Further, no hospital should be allowed to deny them entry on any other issues with identity proofs.
- When an individual gets their family-member treated in one city but has to travel to another city to look for oxygen or essential drugs, they cannot be denied these commodities simply because they are to be bought for an individual admitted in a different city.
- The Centre, in consultation with the States, must formulate guidelines on the stage at which hospitalization is required to ensure that scarce hospital beds are not occupied by persons who do not need them.
Oxygen Allocation and Availability:
The Central Government has argued the following:
- The Ministry of Home Affairs by its order dated 11 Sept. ’20, had constituted an Empowered Group-II as an inter-ministerial body to ensure availability of essential medical equipment and oxygen management.
- Oxygen is used for industrial and medical use, which is in the form of Liquid Medical Oxygen. The major suppliers for both industrial and medical oxygen are steel plants and private entities.
- Oxygen is not produced evenly in India.
- For an estimation of the required oxygen supply, an Empowered Group I was constituted which categorized patients into three categories: (1) Class I comprising 80 percent of the cases which are mild and do not require oxygen; (2) Class II comprising 17 percent of the cases which are moderate and can be managed on non-ICU beds and 50 percent of these may require oxygen (10L/min); and (3) Class III comprising of 3 percent of cases which are severe ICU cases requiring approximately 24L/min oxygen.
- The oxygen requirement of different States is based on the categorization provided by the Empowered Group I. Based on the trend of active cases, the “doubling rate of cases” is calculated for each state. The number of active cases is projected based on the doubling rate and oxygen requirement is calculated.
- To ensure supply of oxygen to all States, a mapping exercise of the sources of supplies with the demand of medical oxygen to the critically affected States was undertaken by the Department of Promotion of Industry and Internal Trade (“DPIIT”), MoHFW, Ministry of Steel, Petroleum and Explosives Safety Organization, oxygen manufacturers etc. During this mapping exercise the States were asked to indicate their projections for the requirement of medical oxygen based on expected active case load.
- Based on these projections, an indicative mapping framework was drawn up and approved, which provided the name of the supply point, the State to which supply was allocated and the quantity to be supplied. Subsequently, due to continuous changes in the number of cases and the need for medical oxygen, a revised projection was issued by the States.
- Following this, a revised plan for medical oxygen to 15 States for meeting their demand was issued. Certain States faced issues despite this allocation. Issues such as logistical bottlenecks in transportation, incidents of local authorities in disrupting supplies to other States were reported.
- The Ministry of Home Affairs also issued orders dated 22 Apr. ’21 and 25 Apr. ’21 under the DMA to direct States/Union Territories to ensure uninterrupted supply of medical oxygen across the country.
- The major principles based on which the amendments were made were to (1) ensure that projected requirement of Liquid Medical Oxygen is allocated as far as possible; (2) allocate sources located within the State or closest to the State while balancing requirements from States which have no/low internal manufacturing capacity; (3) ensure feasible transportation; and (4) ensure minimum disruptions in existing supply chains.
- After the UOI procures and allocates the oxygen to each State, it is the State Government’s responsibility to arrange transportation to pick up their allotted quantity from the supply point.
- The Centre has also put in place an interactive mechanism called the Virtual Central Control Room to monitor and find solutions to any problems that may arise on a real time basis.
Additional steps taken by the Centre to augment the supply of oxygen:
- Allowed licenses to be issued industrial gas manufacturers, by the Drug Controller General of India (“DGCI”), to manufacture medical oxygen within 24 hours of receipt of the application by DGCI.
- Steps have been taken to enhance the production of other liquid products which are required for manufacturing steel and enhance the capacity of liquid oxygen. The Steel sector has made available the liquid oxygen in its storage tanks. Supplies have increased from 1000 MT in the first week of April to 2600 MT on 21 Apr. ’21.
- By an order dated 18 Apr. ’21 the MoHFW had restricted the industrial use of oxygen. Supply of oxygen for all industrial use was completely prohibited on 21 Apr. ’21, except for certain industries (ampoules, vials, pharmaceuticals, petroleum refineries, nuclear energy facilities; and oxygen cylinder facilities.)
- India has 1224 oxygen tankers and efforts are being made to increase this capacity to 2,000 tankers through conversion of nitrogen and argon tankers and import of 138 cryogenic tankers.
- MoHFW is in the process of commissioning 162 Pressure Swing Absorption (154 MT capacity) (“PSA”) plants. PSA is a technology to generate oxygen at a local level.
- Orders have been placed with 2 foreign suppliers namely, (1) SSB Cryogenic Equipment Ltd. for 200 MT and Gulf Industrial Gases Abu Dhabi for 1800 MT. Another order is being placed with M/s Ultra-Pure Gases India for import of 500-1500 MT.
- 1,02,400 oxygen cylinders were procured in Apr. and May 2020 and distributed to States. Orders for additional 1,27,000 cylinders were placed on 21 Apr. ’21. The Centre proposes to address the additional demand through regulated portable oxygen system technology.
- Two private entities, AMNS and JSW are setting up “Jumbo” Covid Centres with 1,000 bed oxygen facilities in Hazira, Vijayanagar and Dolvi, using gaseous oxygen.
- Railways are being used for long distance transport of tankers and an “Oxygen Express”- a double engine train which gets a green corridor- is being run from supply point to destination. It is not possible to bring in oxygen filled tankers in an aircraft.
Based on the above facts and figures, the Solicitor General has stated that there is no dearth of oxygen supply in the country as on date and steps are being taken to continuously augment the supply of oxygen.
However, the Solicitor General has admitted that there has been a shortage of supply to certain States and has attributed this shortage to various factors including the failure of the State Government to life the allocated supply of oxygen from the supply point, transportation bottlenecks etc.
Submissions made by the Government of National Capital Territory of Delhi (“GNCTD”):
- Mr Rahul Mehra, Senior Counsel appearing for the GNCTD stated that it is facing an acute shortage of the supply of oxygen as it had been allocated a substantially lower quantity of oxygen as against its projected demand.
- Due to a surge in cases, the projected demand was revised by GNCTD on 18 Apr. ’21 to 700 MT/day, and this was immediately communicated to the Centre.
- Despite the increase in projected demand, the supply of oxygen has continued in terms of an older allocation order, in which 490 MT/day were allocated.
- The Centre alleged that the GNCTD has failed to offtake the allocated quantity of oxygen from the supply point.
- It has stated that no revised projections have been received from GNTCD till date.
- This Court noted that the Central Government in its affidavit dated 23 Apr. ’21 has admitted that the projected demand for GNCTD had increased by 133 percent from 300 MT/day to 700 MT/day.
- It noted that the situation in Delhi is heart rending and must be remedied immediately.
- In the battle of shifting responsibility of supplying/laying off oxygen, lives of citizens cannot be put in jeopardy.
- The protection of the lives of citizens in paramount in times of a national crisis and the responsibility falls on both the Centre and the State to cooperate with each other to ensure that all possible measures are taken to resolve the situation.
- During the hearing, the Solicitor General stated that he has instructions to the effect that GNCTD’s demand of medical oxygen will be met and that the national capital will not suffer due to lack of oxygen.
- The Court accepted this submission and directed compliance within 2 days from the date of hearing, that is on or before midnight of 3 May, ’21.
- This Court directed the Centre in collaboration with the States to prepare a buffer stock of oxygen to be used for emergencies. It noted that it is critical that a buffer emergency stock of oxygen is created so if the supply chain is disrupted to any hospital in an area for any reason, the buffer or emergency stocks can be used to avoid loss of human lives.
Court’s Recommendations to the Centre:
- Create a mechanism for displaying real-time updates of supply of oxygen from each State to hospitals in each district, along with the remaining stock of oxygen with the hospitals. This information should be shared with the citizens to ensure transparency.
- The UOI shall clarify the steps being taken on planning on the use of oxygen concentrators to reduce the demand of liquid medical oxygen (“LMO”), such that LMO is needed only for critical patients.
- The expected supply of oxygen to be received from outside India should be suitably augmented to cater to anticipated increases in the demand and shortfall of domestic availability.
- A review shall be made of any restrictions on inter-State travel of trucks or tankers carrying oxygen or other medical aid equipment which might cause a hindrance in their movement.
- The Central Government may consider implementing a system to track and map the supply tankers which would allow better management of resources and allow diversion of resources from one State to the other in case of emergencies.
Vaccine Capacity and Disbursal:
- The Centre told this Court that it has constituted a National Expert Group on Vaccine Administration for Covid-19 on 7 Aug. ’20 and operationalization of the immunization programme from Dec. ’20.
- As of 26 Apr. 2021, over 13.5 crore vaccine doses have been administered to Frontline workers, healthcare workers and persons who are 45 years of age and higher.
- On 20 Apr. 2021, the Centre rolled out a revised strategy of Covid-19 vaccination for all persons over 18 years, with effect from 1 May 2021. This new age group consists of approximately 59 crore people, which would require 122 crore vaccines.
- This revised strategy enables vaccine procurement by State Governments and private hospitals, purportedly for accelerating the immunization programme which is critical to curb the pandemic.
- During the hearing, the Court expressed its reservations on the validity of the revised policy under which the States and Private Hospitals are to procure 50 percent of the vaccines to immunize persons in the 18-44 years age group.
- For instance, even this age group would consist of persons who suffer from vulnerabilities.
- Once the vaccination programme has been opened for persons other than the 45+ age group, it would not be logical to impose the obligation to source vaccinations for the 18-44 age group on the State Governments.
- The available stock of vaccines is not adequate to deal with the requirements of both the categories.
The Court directed the Central Government to clarify the following issues:
- Whether the Central and State Governments have introduced any initiatives for ensuring the immunization of persons who do not have access to digital resources.
- Since the Central Government commits to vaccinating persons over 45 years, free of cost, in view of their vulnerability, whether walk-in facilities for vaccination will continue for these persons after 1 Mar ’21.
- Whether the Central or State Governments propose to undertake targeted vaccination drives for persons who are providing on-ground assistance during the second wave of the pandemic-such as crematorium workers.
- Whether, and if so, what steps are being taken by INYAS, the nation-wide mass awareness campaign for Covid-19 vaccination, for ensuring outreach in rural areas and socio-economically underprivileged sections of society.
- Effort must be taken so that a lack of identity proof does not create a hindrance in the process of immunization of all individuals, specifically, the underprivileged.
- Whether the Central Government will revisit its policy by procuring 100 percent of the doses which can then be equitably disbursed to the State Governments; and
- Since the vaccine administration is now to be a shared responsibility of the Union and the States, the Central Government and the States shall provide: (1) a breakup of the current and projected availability of vaccine stocks for the next six (6) months; and (2) a timeline for achieving immunization of the newly eligible 59 crore persons who are aged between 18-44 years.
- The Court noted that prima facie there are several aspects of the vaccine pricing policy adopted by the Centre which requires revisiting.
- All vaccines, whether in the quantity of 50% purchased by the Central Government or the remaining 50%, are to be used for vaccinating citizens. The end use is the same.
- The Central Government proposes to purchase half of the total quantity falling within its fifty per cent quota while for the rest, the manufacturers would declare in advance the price to be fixed, allowing the State Governments to negotiate their terms.
- As of date, the manufacturers have suggested two different prices, a lower price which is applicable to the Central Government and a higher price which is applicable to the quantities purchased by the State Governments.
- It is likely that compelling the State Governments to negotiate with manufacturers on the ground of promoting competition and making it attractive for new vaccine manufactures will result in a serious detriment to those in the age group of 18 to 44 years, who will be vaccinated by the State Governments.
- Prima facie, the rational method of proceeding in a manner consistent with the right to life (which includes the right to health) under Article 21 would be for the Central Government to procure all vaccines and to negotiate the price with vaccine manufacturers.
- Once quantities are allocated by it to each State Government, the latter would lift the allocated quantities and carry out the distribution.
- While this Court did not pass a conclusive determination on the constitutionality of the current policy, it noted that the way the current policy has been framed would prima facie result in a detriment to the right to public health which is an integral element of Article 21 of the Constitution.
- Therefore, it suggested that the Central Government should consider revisiting its current vaccine policy to ensure that it withstands the scrutiny of Articles 14 and 21 of the Constitution.
- The Central Government justified the rationale regarding the differential pricing for procurement by the Central and the State Governments by stating that it is based on the concept of “creating an incentivized demand for the private vaccine manufacturers in order to instil a competitive market resulting in increased production of vaccines and market driven affordable prices for the same.”
Considering the Central Government’s justification for non-interference in the prices being set by manufacturers, this Court sought the following clarifications:
- Whether any other alternatives were considered by the Central Government for ramping up the immunization drive in India, particularly in light of its initial strategy of a centralized free immunization drive;
- The methodology which the Central Government was envisaging to procure adequate vaccine doses for the population prior to the revised strategy which was announced amidst the second wave of COVID-19;
- Whether any studies and figures were relied upon to arrive at the conclusion that decentralized procurement would spur competitive markets to incentivize production and eventually drive down the prices of the vaccines.
- Whether these studies are of relevance in a pandemic when vaccines are a scarce and essential commodity which is being produced by a limited number of manufacturers for a limited number of vaccines;
- Whether, and if so, the Finance Ministry or any other funding organization of the UOI have made any grants/sanctions to Bharat Biotech and the Serum Institute of India in the past, like the current infusion of Rs 1500 crores and Rs 3000 crores, respectively. If so, breakup and corelation with the total cost of development and production of the two vaccines;
- Whether the current procurement prices for the Central Government account for infusion of funds for production, infrastructure and other aid provided by it. If so, the basis on which the same benefit is denied to procurement by State Governments which equally service the needs of citizens;
- The full extent of direct and indirect grant/aid provided for research, development and manufacture of all existing vaccines and future vaccines that it proposes to authorize. For instance, the Central Government has submitted in its affidavit that the Department of Biotechnology has facilitated the trials for Sputnik V.
Potentiality of Compulsory Licensing for Vaccines and Essential Drugs:
- Several drugs that are at the core of the Covid-treatment protocol are under patents in India including Remdesivir, Tociluzumab and Favipiravir.
- In India, the patent regime is governed by the Patents Act, 1970.
- Section 92 envisages the grant of a compulsory license in circumstances of national emergency and extreme urgency.
- Under section 100 of the Patents Act, the Central Government can authorize certain companies to use any patents for “the purpose of the government.”
- Indian companies can begin manufacturing the drugs while negotiating the royalties with the patentees.
- If the Central Government or its authorized company is not able to reach an agreement with the patentee, the High Court has to fix the reasonable royalty that is to be paid to the patentee.
- An alternative is for the Central Government to acquire the patents under Section 102 from the patentees.
- If the Central Government and the patentee are not able to reach a consensus on the price of the patents, it is up to the High Court to fix the royalty.
- Additionally, under section 66 of the Patents Act the Central Government is also entitled to revoke a patent in the public interest.
- The utilization of these flexibilities is also present in the Trade Related Aspects of Intellectual Property Agreement (“TRIPS”) It creates a permissive regime for the carving out of exceptions and limitations that further public health objectives. This is evident from a conjoint reading of Articles, 7,8, 30 and 31.
- According to the 2001 Doha Declaration, TRIPS should be interpreted in a manner supportive of the right of members to protect public health and to promote access to medicines. It recognizes the right of WTO members to use the full extent of the TRIPS flexibilities to secure this objective.
- Para 5(b) and (c) of the Doha Declaration deal with the concept of compulsory licensing and the grounds on which the licenses are granted.
- Several countries, such as Canada and Germany have relaxed the legal regimes governing the grant of compulsory licenses.
Supply of Essential Drugs:
Submissions in the Central Government’s Affidavits:
In relation to Remdesivir, the UOI urged that:
- Remdesivir is a patented drug which is being manufactured in India under licensing agreements between the patent holder, M/s Gilead, a US based company and seven Indian companies. Under such agreements, these Indian companies can manufacture Remdesivir for distribution;
- In its affidavit dated 23 April 2021, it was submitted on behalf of the Central Government that the current production is about 74 lakhs vials per month and once the additional manufacturing sites of the seven manufacturers become operational by May 2021, the production capacity will increase to 90 lakhs vials per month. In its additional affidavit dated 29 April 2021, the Central Government has submitted that as on 23 April 2021, the production capacity has increased to 1.03 crore vials per month;
- The Central Government allocated 11 lakhs vials of Remdesivir to nineteen States with a high case load between 21 to 30 April through a letter issued on 21 April 2021. This allocation was revised and expanded to all States and UTs through a letter issued on 24 April 2021;
- The Central Government has directed the States to appoint nodal officers to ensure unrestricted and timely movement of Remdesivir.
- A control room has been set up in this regard by the National Pharmaceutical Pricing Authority (“NPPA”) which is monitoring supplies as allocated.
- A helpline has been set up by NPPA and manufacturers have been directed to address the hindrances in the movement of the drug.
- A WhatsApp group with nodal officers has also been created to enable coordination and officials of Ministry of Home Affairs (“MHA”), NPPA and Central Drugs Standard Control Organization (“CDSCO”) are also part of the group;
- Remdesivir, its Active Pharma Ingredients (“API”) and formulations have been placed under export ban since 11 April 2021;
- The Ministry of Finance has issued a notification on 20 April 2021 exempting customs duty on the Remdesivir injection, and API of Remdesivir and Betacyclodexterin, which are used in the manufacture of the injection;
- All the SEZ/EOU manufacturing units of M/s Mylan and M/s Honous Lab, who are manufacturing Remdesivir on behalf of some of the seven manufacturers have also been directed to start manufacturing Remdesivir for domestic supply;
- CDSCO has directed all State Drug Controllers on 10 April 2021 to conduct a special investigation drive to prevent hoarding and black-marketing of Remdesivir in the country.
- DCGI and State Drug Controllers have been taking stringent action against such activities and enforcement action has been taken in thirty-four cases across the country;
- MHA has issued an advisory on 22 April 2021 to States and Union Territories to facilitate smooth movement of supplies.
- A “Covid Drug Management Cell” consisting of the Department‟s Senior Officers and others has been constituted on 26 April 2021 to oversee and identify common concerns raised by States in relation to Remdesivir;
- NPPA has revised the maximum retail price of a 100 mg/vial of Remdesivir to Rs 3500; and;
- The Central Government is also looking at the possibility of importing Remdesivir.
The UOI made the following submissions on the availability of Tociluzumab injections:
- Tociluzumab is manufactured by a Swiss Company, M/s Roche, which does not have any manufacturing facility in India or any agreements with domestic pharma companies to manufacture the drug. It is imported in the country by Cipla. India is completely dependent on imports;
- It is listed as an investigational therapy drug (off-label) under the National Clinical Management Protocol for COVID-19 for severe cases. There are domestically produced alternatives which are equivalent to or better than Tociluzumab such as itulizumab, dexamethasone and methyl prednisolone.
- However, an incorrect public perception has been created that only Tociluzumab can treat the inflammatory burst condition in COVID- 19 patients since it is an imported drug.
- This has led to the acute shortage in the availability of the drug and has created public panic;
- The supply of Tociluzumab is being monitored by NPPA and CDSCO.
The UOI made the following submissions on the availability of other drugs:
- The National Clinical Management Protocol for COVID-19 does not include Favipirarvir (popularly known as Fabiflu) due to insufficient peer reviewed evidence to substantiate its use in mild to moderate cases of COVID-19.
- However, it is still being prescribed by certain doctors.
- On 24 April 2021, Department of Pharmaceuticals, NPPA and DCGI had reviewed the production and supply of other drugs such as Favipiravir, Enoxaparin, Ivermectin, Methylprednisolone, Paracetamol and Hydroxy chloroquine. A meeting was conducted on 25 April 2021 by NPPA and DCGI with manufacturers to review stock position, availability, and production plans.
- The Central Government should provide the Court with the details of the actual rate of production and a breakup of demand for the drug from different States.
- The Central Government should provide the Court with the details of the methodology used for the allocation of the stocks of drugs.
- Several other drugs like Favirpiravir, Tociluzumab, Enoxaparin, Ivermectine, Methlyprednisone, Paracetamol and Hydroxychloroquine are being priced at exorbitant rates. The Central Government is suggested to consider its powers under paragraphs 19 and 20 of the Drug Price Control Order, 2013.
- The Central Government is suggested to consider importing other essential drugs, other than Remdesivir. This Court emphasized that this does not constitute a direction to the Centre and ultimately this decision falls under the domain of the executive.
- The Central Government is suggested to consider the augmentation of production of other essential drugs which are not mentioned in the National Clinical Management Protocol for Covid-19, like Favipiravir.
- The Central Government is suggested to consider using its statutory powers under sections 92, 100 or 102 of the Patents Act (as seen earlier).
- The Central Government is suggested to take steps to combat black marketing of the essential drugs. To clamp down on this practice, Central Government can consider constituting a special team to identify and prosecute those who: (a) sell medical grade oxygen/COVID-19 medicines at exorbitant prices; and (b) sell fake substances and recover the concerned substances. A protocol for ambulances must also be evolved to avoid citizens being exploited by extracting unconscionable charges. The Central Government can consider creating a platform for easy reporting and redressal of such cases.
- The Central Government is suggested to consider the services of the batch of medical, nursing and pharmacy students who graduated in 2020 and those who would be in the process of graduating in 2021, to augment the services of the workforce in the health sector.
- The Central Government should also consider using health care workforce available with the armed forces and paramilitary forces for the purpose of vaccination.
Court’s Directions with Respect to Information Rights of Citizens:
- Further, this Court stated that the Central and State Governments should ensure that they immediately cease any direct or indirect threats of prosecution and arrest to citizens who air grievances or those who are attempting to help fellow citizens receive medical aid.
- If this keeps happening, the Court shall be constrained to use the powers available to it under contempt jurisdiction.
- The Court noted that as such, preventing clampdowns on sharing of information on online platforms is not just in the interest of individuals sharing the information, but the larger democratic structures of our nation.
- Without the ready availability of such information, it is entirely possible that the COVID-19 pandemic may turn into a tragedy worse than what it already is.
- Another reason to allow the sharing of information is because sharing information widely will help in the creation of a “collective public memory” of this pandemic. The presence of collective public memory, which refers “to an extant and taken-for-granted group memory”, is important for the creation of knowledge of the problems plaguing us today, so they may be passed on across time.
Lastly, the Court took note of the treatment meted out to public healthcare professionals during this Covid-19 pandemic as being less than ideal. This Court expressed its desire that the Central and State Governments consider the welfare of all the public healthcare workers.
Conclusion: In terms of the above discussion, this Court passed the following directions:
- The UOI shall ensure, in terms of the assurance of the Solicitor General, that the deficit in the supply of oxygen to the GNCTD is rectified within 2 days from the date of the hearing, that is, on or before the midnight of 3 May 2021;
- The Central Government shall, in collaboration with the States, prepare a buffer stock of oxygen for emergency purposes and decentralize the location of the emergency stocks. The emergency stocks shall be created within the next four days and is to be replenished on a day to day basis, in addition to the existing allocation of oxygen supply to the States;
- The Central Government and State Governments shall notify all Chief Secretaries/Directors General of Police/Commissioners of Police that any clampdown on information on social media or harassment caused to individuals seeking/delivering help on any platform will attract a coercive exercise of jurisdiction by this Court. The Registrar (Judicial) is also directed to place a copy of this order before all District Magistrates in the country;
- The Central Government shall, within two weeks, formulate a national policy on admissions to hospitals which shall be followed by all State Governments. Till the formulation of such a policy by the Central Government, no patient shall be denied hospitalization or essential drugs in any State/UT for lack of local residential proof of that State/UT or even in the absence of identity proof;
- The Central Government shall revisit its initiatives and protocols, including on the availability of oxygen, availability and pricing of vaccines, availability of essential drugs at affordable prices and respond on all the other issues highlighted in this order before the next date of the hearing, that is, 10 May 2021. Copies of all affidavits to be served upon the Amici in advance; and
Several other suggestions have been made before this Court in IAs and writ petitions filed by diverse parties. To to streamline the further course of hearing, we have requested the Amici to collate and compile these suggestions which would be taken up later. The present order has focused on certain critical issues in view of the urgency of the situation.
 Suo Moto Writ Petition (Civil) No. 3 of 2021.
 2020 SCC OnLine SC 652.