The Evening Wrap: Petition in SC asks for vaccine clinical trial data to be made public
| | The Evening WrapFriday | 14 May, 2021 |  |
| Welcome to the Evening Wrap newsletter, your guide to the day's biggest stories with concise analysis from The Hindu. |
 Open in browser |  More newsletters |
Petition in Supreme Court asks for vaccine clinical trial data to be made public |
|---|
|
A petition has been filed in the Supreme Court to make public the segregated data of clinical trials of Covid-19 vaccines administered under the Emergency Use Authorisation granted by the Drugs Controller General of India (DCGI). Former member of National Technical Advisory Group on Immunisation Dr. Jacob Puliyel, represented by advocate Prashant Bhushan, asked the court to direct the government, its bodies and the vaccine manufacturers – the Serum Institute of India and Bharat Biotech -- to transparently reveal clinical trial and vaccination data, including the recording and reporting of adverse events. Further, the petition urged the court to direct the government to not issue any "coercive mandates" for use of "these inadequately tested vaccines". Bhushan argued that courts should "reiterate that vaccine mandates are repugnant to the right of humans to autonomy and right to self-determine what may be injected into their bodies". "The respondents (Centre, its agencies like DCGI and ICMR and vaccine manufacturers) have maintained opacity about the clinical trial data of the two vaccines administered through emergency authorisation in India. Non-disclosure of this important data violates the basic ethics of clinical research that requires results of clinical research studies to be published and brought to the knowledge of the medical community, participants to the research, and the general population," the petition said. Dr. Puliyel, also represented by advocate Cheryl d'Souza, said the lack of transparency raised concerns over the efficacy and safety of the two vaccines. "The World Health Organisation (WHO) has released a strong statement advocating for public disclosure of all clinical trial results. According to the statement, when data is not released it means that doctors, patients and medical regulators cannot make informed decisions about which treatments are best," the petition stated. The petition said transparency in publishing clinical trial data by the Central Drugs Standard Controls Organisation (CDSCO) that granted final approval for the vaccines by various manufactures to enter the immunisation chain flowed from Section 4 of the Right to Information Act, 2005, which required the government to make "proactive disclosures of its records through the internet and other means of communications to the general public". Vice President, Lok Sabha Speaker say no to virtual meetings of Parliamentary panelsThe parliamentary panels cannot meet virtually till the necessary rules are amended by both Houses of Parliament, the Rajya Sabha secretariat said in reply to a letter written by Leader of the Opposition Mallikarjun Kharge on Friday. The standing committees of Parliament, which are non-partisan platforms to analyse the functioning of the government, have not met even once since the onset of the second wave of the pandemic. More than a year after the demands were first raised by the panels' chairpersons, the necessary changes in the rules have not been amended since their physical meetings were held for a few months when it was believed that Covid-19 was on the wane. Last week, in a letter to Rajya Sabha Chairman Venkaiah Naidu, Kharge said that Parliament could not be a mute spectator to the suffering of the people. He urged Naidu to allow online meetings of the panels. Naidu and Lok Sabha Speaker Om Birla last year held a series of meetings where it was argued that the "confidentiality clause" dictated that only physical meetings of the panels can be held, keeping the proceedings and deliberations secret. It was decided that the issue be referred to the committee on Rules in both the Houses. "As physical meetings of the committees were being held regularly, following the guidelines strictly, the matter rested there and the situation had not arisen for considering the matter by the Rules Committees in both the Houses," the letter stated. The Rajya Sabha secretariat assured Kharge that the meetings of the committees would be considered "shortly once the situation improves for better". It was informed that the issue of "confidentiality can be resolved during the session as any amendment to the rules can be approved by the respective Houses only after the matter is considered by the Rules Committee." Senior Congress leader and chairman of the committee on Home Affairs Anand Sharma who, on Tuesday, wrote to Naidu making the same demand, said: "In a democracy, accountability can neither be delayed nor evaded." His colleague and chairman of the panel on Science and Technology Jairam Ramesh wrote on Twitter that nowhere in the world had Parliament run away from its duties like in India. "In spite of repeated requests for almost a year, virtual meetings of Standing Committees have been inexplicably disallowed. The PM has all his meetings virtually, but 30 odd MPs cannot," he said. Congress slams Centre as Delhi Police question Youth Congress chief over Covid-19 relief workThe Congress on Friday asked if providing oxygen cylinders and life-saving drugs to Covid-19 patients is a "crime" under the Narendra Modi government. This follows the questioning of the Indian Youth Congress (IYC) chief B V Srinivas by the crime branch of the Delhi Police. "Today every person has to decide if providing oxygen, helping people to get life-saving drugs like Remdesivir, arranging beds or providing food to ambulance drivers is a crime. It seems to be a crime according to Prime Minister Narendra Modi," said Congress chief spokesperson Randeep Surjewala. "Today, Modi ji and [Home Minister] Amit Shah Ji sent Delhi Police to the office of the IYC office to question Srinivas ji. Can there be a more despicable act than this? Is it a sin committed by the Youth Congress and the Congress to provide help that the Modi government has been unable to do?" he stated. The government should be "ashamed" of itself, he said. He asserted that the Youth Congress would continue to provide oxygen and other life-saving drugs to needy patients. "They [Delhi Police officials] wanted to know the details of how are we helping people. We answered all their questions," Srinivas said. Using hash tag #IStandWithIYC to express solidarity, former Congress chief Rahul Gandhi tweeted, "The one who saves is always greater than the one who destroys". While former Union Minister Jairam Ramesh tweeted to call the Delhi Police's move as "atrocious", party general secretary Priyanka Gandhi Vadra too reacted on Twitter when former Rajya Sabha member Shahid Siddiqui said that a police official had also come to his place to find out how Vadra mananged to help him with Remdesivir injections for his wife. "If helping someone in need is now a crime, I will commit it again and again. To my mind it's a far greater crime to silently watch and do nothing while people die desperately searching for medicine and gasping for air," Vadra said, lending her support to the IYC. At an online press conference, All India Congress Committee in charge of Delhi Shaktisinh Gohil said Delhi Pradesh Congress Committee chief Anil Chaudhary and former MLA Mukesh Sharma also received notice for such questioning. A Delhi Police official claimed that the questioning followed a direction from the Delhi High Court on a writ petition filed by Dr. Deepak Singh about politicians involved in illegal distribution of Covid-19 medicines, etc Sputnik V to be priced at ₹995.40 per doseSputnik V has now joined India's immunisation programme against Covid-19, with the first dose of the Russian vaccine being administered in Hyderabad today. The maximum retail price of the imported vaccine is ₹995.40 per dose. "As part of a limited pilot, the soft launch of the vaccine has commenced and the first dose was administered in Hyderabad on May 14," said Dr. Reddy's Laboratories, the marketing partner in India for the vaccine of the Russian Direct Investment Fund (RDIF). It follows the imported doses of Sputnik V that arrived in the country on May 1, receiving regulatory clearance from the Central Drugs Laboratory, Kasauli, on May 13. Further consignments of Sputnik V are expected over the upcoming months. Subsequently, supply of the vaccine will commence from Indian manufacturing partners. Many districts in Kerala on rain alertDistrict administrations in Kerala have scrambled to deal with a potential rainfall-related emergency, with the turbulent weather conditions over the Arabian Sea expected to trigger torrential rains over the next few days. Five Kerala districts — Thiruvananthapuram, Kollam, Pathanamthitta, Alappuzha and Ernakulam — were on red alert today (Friday), given the likelihood of extremely heavy rainfall, according to a corrected weather update issued by the India Meteorological Department (IMD) at 1 p.m. In a 10 a.m. update, the weather agency had downgraded the red alerts that were sounded in three districts on Friday to orange alerts. As per the latest update, Kottayam, Idukki, Thrissur, Palakkad , Malappuram, Kozhikode and Wayanad are on orange alert today (Friday) and Kannur and Kasaragod on yellow alert. Covid Watch: Numbers and DevelopmentsThe number of reported coronavirus cases from India stood at 2,41,00,326 at the time of publishing this newsletter, with the death toll at 2,62,951. Lockdown restrictions in Tamil Nadu are set to become more stringent from tomorrow. Provision and grocery stores and shops selling meat would be allowed to function only from 6 am to 10 am across Tamil Nadu from Saturday. Tea shops will be closed. These shops were earlier allowed to remain open from 6 am to 12 noon. "E-registration would be made mandatory from May 17 for inter-district and intra-district movement even for essential purposes, weddings or funerals of close relatives and also for travelling for medical treatment and for elderly care," a Government release said on Friday evening. Shops on pavements, which were earlier allowed to sell vegetables, flowers and fruits till 12 noon, would not be allowed any more. In neighbouring Kerala, Chief Minister Pinarayi Vijayan on Friday extended the state-wide lockdown till May 23. Vijayan said the government is taking steps to mitigate the ill-effects of the lockdown, chiefly loss of livelihood. He announced free food kits for the population and immediate distribution of social welfare pensions. The government would support Anganwadi teachers and Kudumbashree units, he added. Evening Wrap will return tomorrow. |
| |
Post a Comment