With the outbreak of COVID-19, it was expected from drugs regulators to evaluate the present regulatory regime to make it more conducive for research and development activities towards production and distribution of the COVID-19 vaccine.
Generally, all vaccines, including the vaccines against coronavirus infection manufacturer/imported into the country are required to comply with the requirement speciified under the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rule, 1945, new Drugs and Clinical Trial Rules, 2019 and guidance for industry and other applicable guidelines issued by the Central Drugs Standard Control Organization (CDSCO) from time to time.
Addressing of production and distribution of COVID-19 vaccine
In view of the rapid spread of the COVID-19 pandemic and due to need for immediate research and product development, the government of India, the Ministry of Science and Technology, Department of Biotechnology issued office memorandum dated 20th March, 2020, to deal with the application for development of vaccines, diagnostics, etc.
The measures taken by the government includes approval of applications (which are fulfilling of essential criteria) within seven days from the date of receipt of application, permission for initiating research work, approval of Form 29/test licence/NOC to manufacturer by CDSCO within 10 days from the receipt of application.
The government instructed CDSCO to make a corona unit to address queries on development of diagnostics, prophylactics and therapeutics for COVID-19. It also formed an empowered committee to examine the applications and to recommend the applications for approval as per the agreed timeframe.
Since supplemental oxygen therapy is a part of clinical management of COVID-19 patients; therefore, to ensure the availability and supply of oxygen for medical use across the country, the DCGI granted permission to manufacturers of industrial oxygen to manufacture oxygen for medical use in light of COVID-19.
Thereafter, on 26th May, 2020, the Government of India, Ministry of Science and Technology issued another office memorandum with respect to rapid response regulatory framework for COVID-19 vaccine development. Vide the said Office Memorandum, the government of India rolled out rapid response regulatory framework to deal with applications for COVID-19 vaccine development. As per the said regulatory framework, it was decided by the regulators interalia to consider the data generated outside India with respect to clinical studies.
In September 2020, CDCSO rolled out draft regulatory guidelines for the development of vaccines with special construction for COVID-19vaccine. These guidelines are intended to act as supplementary guidance to the New Drugs and Clinical Trials Rules, 2019 in consideration of WHO, USFDA and EMA guidelines as well as other applicable guidelines of CDSCO to facilitate early development of safe, effective and quality vaccines, more especially COVID-19 vaccines in the country. The aforesaid guidelines provided instructions to the developers to ensure that vaccines are well-constructed and manufactured constantly, vaccine remain stable at the recommended storage conditions for the duration of clinical trial during clinical development stage and throughout its shelf-life post-approval. Further, as per the said guidelines, challenged studies in relevant animal species and non-human problems may be conducted concurrently with clinical trial.
Further, the government has fast-tracked emergency approvals for foreign-produced COVID-19 vaccines that have been granted EUA in other countries to expand the basket of vaccines for domestic use and hasten the pace and coverage of vaccination. The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), after comprehensive deliberation, recommended that vaccines for COVID-19, which have been developed, and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO (Emergency Use Listing), may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under the second schedule of the New Drugs & Clinical Trials Rules 2019. The Union Government, after due consideration, has accepted the recommendation of NEGVAC.
Subsequently, CDSCO on 15th April, 2021 and 1st June, 2021, released guidance for approval of COVID-19 vaccine for restricted use. As per the guidance note dated 1st June, for approval of COVID-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO EUL, and which are well-established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post-approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli, can be exempted, if the vaccine batch/lot has been certified and released by the National Control Laboratory of Country of Origin.
CDSCO has cleared way for the import of COVID-19 vaccines from other countries into India. As per the latest CDSCO guidelines, the ready-to-use imported COVID-19 vaccines would be utilised entirely in the “other-than-the-government-of-India channel.” This means these vaccines can be used by private companies and state governments. Any private entity or government sector entity, which wants to import the COVID-19 vaccine for vaccination as per the above-mentioned guidelines is required to follow certain procedures.
Undoubtedly, the Indian drugs regulators have acted proactively to address the issues pertaining to production and distribution of COVID-19 vaccine, and, as per the Government of India, there is no shortage of COVID-19 vaccine in the country, at present. However, it is a general perception of the stakeholders that since vaccine production in the country is dependent on the availability and supply of raw materials from other countries, there is a need for major push on active pharmaceutical ingredient (API) to be produced within the country in order to avoid future contingencies.