State should issue global tenders for COVID-19 vaccines, fix price caps for such vaccines: PIL in Madhya Pradesh High Court

In view of the shortage of COVID-19 vaccines in the country, a Public Interest Litigation (PIL) has been moved before the Madhya Pradesh High Court seeking directions to the State to take steps to invite global tenders from successfully tested vaccine manufacturing companies (Sunil Gupta v State of Madhya Pradesh and ors)..Filed by Advocate Sunil Gupta through Advocate Siddharth R Gupta, the petition raised the following contentions:.1. Difficulties being faced in COVID-19 vaccinationThere are various problems being faced in carrying out COVID-19 vaccination across states in India, the petitioner submitted. These issues include non-availability of slots, shortage in supply of vaccines, no mechanism in existence by which the Cowin website can notify users when a slot is available in their area, lack of vaccination staff with resources getting diverted for patient care duties given rising admissions at hospitals, low number of hospitals offering vaccines to persons below 45 years of age etc. "More so, 50% of the procurement of vaccines is now left to be arranged by the State making them compete against each other in the international market arena," the petitioner added.In the backdrop of these issues, there has also been profiteering by private hospitals and medical practitioners, the petitioner stated. "Where on one hand, the State Government is not able to ensure speedier and widespread vaccination due to availability of doses, on the other hand, private entities across the country are able to squeeze a lion’s share in the pie by getting the doses and vaccinating the people at much higher rates than that on which the Central Government is procuring, i.e., at the rate of Rs. 150 per dose per person," he further submitted. The petitioner contended that there is no level playing field or bargaining power available with the States as only two players are currently selling vaccines in India - Serum Institute of India (Covishield) and Bharat Biotech (Covaxin)..2. Other viable COVID-19 vaccines that can be procured through global tendersThere are multiple other players at the global level whose vaccines have been successful and have been approved by their respective regulatory authorities, the petitioner pointed out. In this regard, reference was made to the following vaccines:Pfizer-BioNTech Covid-19 vaccine (by Pfizer) Moderna Covid-19 vaccine (by Moderna Biotech) Johnson & Johnson Covid-19 vaccine (by Janssen Pharmaceutical Companies) Inviting vaccines at a global level from international players will also evoke interest by the international companies for orienting their resources towards supplying their drugs in India. This would meet the acute shortage of vaccines being faced by various states including the State of Madhya Pradesh, it was submitted.Involving multiple players in the field will also enable the State governments to go for the best choice. It could grant more bargaining power with international players as well as domestic companies for the supply of vaccines, it was stated. The petitioner added that some international players like Pfizer, Moderna and Johnson and Johnson have already applied to the Drugs Controller General of India for necessary approvals so that they can also participate in the supply of vaccines in India. .3. Legal provisions already in place to call for global tenders from other vaccine companiesThe petitioner pointed out that there are provisions already in place under the New Drugs and Clinical Trials Rules, 2019 for granting swift approval to a new drug when it is meant for the treatment of serious or life threatening conditions i.e. for ‘accelerated approval process’. On April 15, 2021, the Central government issued an order granting emergency accelerated approval for foreign-produced COVID-19 vaccines in India in terms of the Rules of 2019. Apart from the currently distributed Covishield and Covaxin, the Indian government has also granted approval to procure the Russian vaccine, Sputnik V, it was noted. Further, states have already floated global tenders inviting vaccines from a number of international manufacturers of COVID-19 vaccines or have already taken in-principle decisions for initiating and floating the same. The State of Uttar Pradesh already floated a tender for 40 million doses (4 crore) of the vaccine, the petitioner noted. The State of Odisha has taken the decision to invite a global e-tender from the manufacturers for the procurement of vaccines, it was added. The States of Karnataka, Maharashtra, Andhra Pradesh, Telangana and Delhi have also taken the in-principle decisions to float global e-tenders, the plea highlighted.Notably, the petitioner called for the Centre to divulge the approval status in India when it comes to international vaccines that have already been granted approval by regulatory bodies governing such international players. " ...since in-principle decision has been taken by the respondent authorities specially the Central government and the DCGI of putting companies approved by international agencies including WHO for expediting the permission/approval of international vaccines companies who already enjoy approval from US-FDA, EMA, UK-MHRA, PMDA Japan, therefore the central government must also be directed to place on record the approval status of those companies and be directed to take the decision at the earliest in terms of the appropriate applicable procedure," the petition stated..4. States should fix prices of vaccines procured through global tendersThe petitioner also submitted that states should take entire control of vaccination and immunization drives. This would also mean that the crucial role of price fixation would be carried out by the State once the global tender is floated by it. The State must not only float the tender and call for the vaccine, but must also ensure that the vaccines are administered to each and every citizen at the fixed capped price, the petitioner submitted. "This will eliminate any prospects of profiteering, hoarding and black marketing of the vaccine, procured through the Global e-tender by the State government. Obviously the private sector can be involved, but subject to the aforesaid regulatory control of the State government. This will ensure that the efforts of the State translate into tangible benefit reaching each and every person of the society," the plea said..In view of the above contentions, the petitioner made the following prayers before the High Court:1. Direct the State of Madhya Pradesh to initiate the exercise of inviting global tenders for the procurement of a fixed lot of COVID-19 vaccines to immunise citizens through a State-level immunization programme. 2. Direct the Central government and its agencies, specifically the Central Drugs Standard Control Organisation (CDSCO) to take a final decision on the applications of various international manufacturers of the COVID-19 vaccine in terms of the accelerated procedure stipulated under the 2019 Rules and the Centre's April 15 order. 3. Direct the State of Madhya Pradesh to fix the upper cap/ceiling on the rate at which COVID-19 vaccines (after procurement through a global tender) shall be supplied and administered, both by public as well as private players.