It, however, argued against the use of statutory provisions like compulsory licensing to influence pricing of vaccines by the two domestic firms — Serum Institute and Bharat Biotech — saying given the financial risk the firms have taken, negotiated pricing would be a prudent approach.
Having come under fire from the Supreme Court over its revised vaccination Covid-19 strategy, the Centre has told the top court in an affidavit that the policy is not only “just and non-discriminatory” but would ensure that all citizens have the option of getting their shots free, uniformity in pricing for the states and that the vaccine manufacturers do not unduly enrich themselves out of public money.
It, however, argued against the use of statutory provisions like compulsory licensing to influence pricing of vaccines by the two domestic firms — Serum Institute and Bharat Biotech — saying given the financial risk the firms have taken, negotiated pricing would be a prudent approach. Anyway, the people as ultimate beneficiary of the vaccination would not be adversely impacted by this as ‘all states’ have announced free vaccination to all eligible population (those above 18 years of age), it noted.
The Centre also said that the prioritisation of age groups for vaccination and a step-wise, layered approach followed was in sync with international practice and the World Health Organisation’s guidelines. The Centre also vowed to speed up the pace of vaccination by making available to Indian people prophylactics from other vaccine producers like Pfizer, Moderna and J&J, all of which it is in talks with. It also submitted that against approval from DCGI, Dr Reddy’s Laboratories has already imported the first consignment of 1.5 lakh Sputnik doses.
On the Centre getting vaccine at a lower rates than the states, the government said this is because it has placed much larger orders than the states and private hospitals.
“Due to consultations and ‘persuasion’ by the central government both the manufacturers of vaccine, Bharat Biotech and Serum Institute of India, have declared their respective prices which are uniform for all state governments. The distribution of the vaccine amongst the States is based on equitable and rational criteria to eliminate and possibility of difference in bargaining power of one state and have a detrimental impact on the resident of the other State,” it said.
The apex court on April 30 had asked the Centre to “revisit” its revised Covid-19 vaccine procurement policy, saying “the manner in which 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”.
The government had on April 9 announced a ‘liberalised and accelerated’ Covid-19 vaccination programme beginning May 1, where all adults above 18 years of age will be eligible to be vaccinated. Also, vaccine manufacturers have been empowered to release up to 50% of their supplies directly to state governments and in the open market at pre-declared prices.
Prices for states and private hospitals were originally higher and were reduced only after outrage. While the Centre continues to spend only Rs 150 per dose for either Serum Institute’s Covishield or Bharat Biotech’s Covaxin, states must pay Rs 400 per dose for Covaxin and private hospitals Rs 1,200. Covishield costs Rs 300 per dose for states and Rs 600 for private hospitals.
Clarifying its basis and rationale on the pricing of the two vaccines, according to the affidavit, “differential pricing is based on the concept of creating an incentivised demand for the private vaccine manufacturers in order to instill a competitive market resulting in higher production of vaccines and market driven affordable prices for the same. This will also attract offshore vaccine manufacturers to enter the country. This will result in increased availability of vaccine”.
Besides, “Serum Institute of India has ramped up production from 5 crore doses/month to 6.5 crore doses per month and further ramp-up is expected by July 2021. Bharat Biotech has also increased production from 90 lakh/ month to 2 crore doses/ month and further increase is expected upto 5.5 crore doses/month by July 2021. Sputnik-V is expected to increase production from 30 lakhs to 1.2 crore doses/month by July 2021”, the government stated, adding that the regulatory and testing processes for foreign vaccines have been simplified so as to accelerate the access to vaccines.
The Centre also told the top court that 100% advance of Rs 1,732.50 crore was released to SII for 11 crore doses of Covishield vaccine for May, June and July. Additionally, 100% advance of Rs 787.50 crore was released to Bharat Biotech for five crore Covaxin doses for the three months, it added.
On the issue of invoking compulsory licensing of provisions under the Patents Act to ensure availability of vaccines and drugs, the government said that the main constraint is in availability of raw materials and essential inputs and, therefore, any additional permissions and licenses may not result in increased production immediately.
The affidavit stated that the ministry of health is making all efforts to enhance the availability of antiviral drug remdesivir through ramping up of production and sourcing through imports.
The Centre had filed an affidavit in response to questions posed by the top court last week.
Defending its policy, the Centre urged the SC against any “judicial interference” and saying “in the context of a global pandemic, where response and strategy of the nation is completely driven by expert medical and scientific opinion, there is little room for judicial interference”.
“Any overzealous, though well-meaning judicial intervention may lead to unforeseen and unintended consequences, in absence of any expert advice or administrative experience, leaving the doctors, scientists, experts and executive very little room to find innovative solutions on the go,” it said
According to the Modi government, “in view of the unprecedented and peculiar circumstances under which vaccination drive is devised as an executive policy, the wisdom of the executive should be trusted”, it added.
In the affidavit, the Centre further contended that the Drugs Controller General of India (DCGI) had communicated to all state drugs controllers (SDCs) that there should be zero tolerance to any kind of hoarding or black marketing of drugs, including remdesivir, and also to instruct their enforcement staff to keep strict vigil and take stringent action.
The Supreme Court on Monday adjourned the hearing till Thursday due to technical glitches.