Emergency Approval of COVID- 19 Vaccines in India
Written by Tanya Kukade [i] and Mr Sanjay Kumar [ii]
[i] Final year student, Symbiosis Law School, Pune
[ii] Ex Partner KSK Advocates
Disclaimer: Please note that the views expressed below represent the opinions of the article's author. The following does not necessarily represent the views of Law & Order.
The past few months have seen circulation of talks of various vaccines being manufactured or imported to India in light of the COVID-19 Pandemic looming over our country. However, the efforts of this industry have not been aloof to controversies in terms of the procedures, trials availability and efficacy of the vaccines. In this article, we will analyze the controversy surrounding the vaccines approved in India for the population in light of New Drugs and Clinical Trial Rules, 2019 (“CT Rules”) and various notifications issued by Central Drugs Standard Control Organization (“CDSCO”).
What led to the issues
There are two vaccines which are being distributed in India. One of them being Covaxin which is developed and manufactured by Bharat Biotech in collaboration with Indian Council of Medical Research and National Institute of Virology and the other one is Covishield which has been developed by University of Oxford along with Astrazeneca and is manufactured by Serum Institute of India. Recently, Sputnik V a vaccine registered by the Ministry of Health, Russia has received emergency authorization by DCGI to be marketed by Dr. Reddy Laboratories Limited in India.
In India the procedures for clinical trial and approval of new drug are regulated under Drugs and Cosmetics Act 1940, Drugs and Cosmetics Rule, 1945 and CT Rules.
Approvals for vaccines are only granted if the drug regulator is satisfied with the results of the trials conducted about safety, immunogenicity and efficacy.
The trial data of efficacy for both vaccines was not available in the public domain since the three trial phases were not completed initially. The lack of data transparency before getting the nod for mass vaccination led to a controversy over the two COVID-19 vaccines. Although, the approvals by the drug regulator were conditional to ensure such data is provided at the earliest.
Covishield was evaluated in July 2020 in the phase I/II single-blind randomized trial with 1077 participants. The initial results of the Phase III trials released in December last year showed the efficacy of the vaccine to be 70.4 percent. The data was based on the results shown by 11,636 volunteers across the UK and Brazil.
In terms of Covaxin, the regulator in January 2021 approved the vaccine for "restricted use in emergency situations in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains”. Similar concerns of approval prior to efficacy data from Phase III trials was raised in this regard. General public wondered how a vaccine was cleared for emergency use by millions of vulnerable people when its trials were still underway.
Exemptions in development of COVID-19 Vaccines
Even though it may be noticed that certain rules have been deferred by the government in the public interest to meet the emergent situation that has arisen out of COVID-19, the permission granted is subject to a few conditions.
In May 2020, the regulator announced a ‘Rapid Response Regulatory Framework’ to provide a fast track approval mechanism in relation to approvals for potential vaccines. The same has been highlighted in a recent notification by DCGI.
The conditions for issuing permission for Restricted Use in Emergency situation of vaccines so approved for opting a safe and seamless approach being:
1. Vaccines to be used as per guidelines prescribed under National COVID-19 vaccination programme.
2. Preclinical studies done outside India may be considered and the application would be examined based on quality of such data that is generated.
3. Data generated outside India will be considered and examined and an abbreviated pathway may be considered for COVID-19 vaccine, based on scientific rational and level of completeness of data in human trials in addition to satisfactory preclinical data.
4. Applicant to conduct post approval bridging clinical trials after such approval within 30 days.
In addition to such conditions for approval, CDSCO issued a notice for waiver of CT on Indian Population for approval of new drugs which have already been approved outside India. Second Schedule to the CT Rules provides for the procedure for bridging trials to be conducted in India as a substitute for the Clinical trial process of a drug already approved outside India. In regard of which Rules 91 to 97 assist in obtaining the necessary permissions for manufacture of such new drug.
The Ministry of Health and Family Welfare vide press release dated 9th March 2021 granted permission to various organizations to manufacture COVID- 19 vaccines, namely – Covaxin, AstraZeneca upon complying with such conditions or promises thereof.
Covishield and Covaxin passed Phase I/II of clinical trials. Covishield submitted its safety and efficacy data of Phase II/III in UK, Brazil and South Africa along with on-going phase II/II trial data in India which was found to be comparable. Based on the data provided by the respective countries and organizations involved in its manufactures, the vaccines were approved for circulation in light of the pandemic. The process followed was an accelerated process although all conditions pertaining to the risk and efficacy has been substantially provided by the companies and Phase III data was promised within the months following such approval.
Thus, the idea of standardization of efficacy endpoints across clinical trials was facilitated through the various notifications issued by the Ministry of Health and Family Welfare jointly with the CDSCO. Each vaccine approved for manufacture or import in India passed these conditions imposed by the regulator in addition to certain post-trial conditions that needed to be satisfied. In terms of Covishield and Covaxin exemptions have been granted by the government to accelerate the process of provision of vaccines to the population although the licensing requirements under the CT Rules continue to apply as a necessary condition for the manufacture or import of vaccines in India.
In terms of regulatory conditions, the Vaccine manufacturers are required to obtain the necessary marketing authorisation for sale or distribution through Form CT-06 and CT-23 to conduct trials of vaccine for COVID-19, followed by an application under Rule 75 or 75A to the concerned licensing authority appointed by the State Government along with the permission obtained for conducting a clinical trial through Form CT-06 under the CT Rules, 2019.
Certain media reports suggested that the Covishield or the AstraZeneca Vaccine has been banned in few European countries due to blood clots being a possible side effect although the World Health Organization has asserted that no such link between the vaccine and blood clots was successfully established. This is a matter open to investigation by researchers based on a close study on individuals who may have reported such side-effects and proper evidence of such reactions has not yet been established by the claimants.
Safety and efficacy of vaccines are of primary importance and cannot be compromised as the entire existence and purpose of vaccine generation to fight diseases depends on such safety data that the companies are required to provide. The primary Safety assessments which should have been followed concerning COVID-19 vaccine were duly followed. The Government in its aim to provide the population with prompt measures against the pandemic, introduced certain exemptions in the Clinical trial process while also ensuring that the quality and efficacy of the vaccines is not compromised.
The guidelines issued by CDSCO for the development of COVID-19 vaccines is well-founded and in adherence to the Drugs and Cosmetics Act 1940, Drugs and Cosmetics Rule, 1945 and CT Rules 2019 and the vaccines developed therein are legal and valid for distribution and admission in India.
In the end it is a race to save the mankind.
 Press Release issued by DCGI on 3rd January 2021, https://pib.gov.in/PressReleseDetail.aspx?PRID=1685761. Notification No. BT/03/27/2020-PID issued on 26th May 2020, https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk1NA.  Notice X-11026/07/2020-PRO issued by CDSCO on 15th April 2021.  Regulatory guidelines for development of vaccine with special consideration for Covid-19 notified by CDSCO on 21st September 2020.  New Drug and Clinical Trial Rules, 2019.
 Ministry of Health and Family Welfare, Press Release dated 9th March 2021, https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1703442.