More than a year long struggle with Covid-19 induced restrictions, yet the pandemic shows no signs of abating. With each wave and variant posing a situation grimmer than the earlier, vaccine seems to be the only silver lining. Everyone is looking towards the selected pharmaceutical companies currently producing millions of doses of vaccines.

India, despite being the largest vaccine producer in the world, accounting for more than 60% of vaccine supply to the UNICEF, is facing vaccine shortages severely affecting its predetermined vaccination schedule, although several Indian pharma companies continue their endless efforts to develop and/or acquire vaccine from foreign developers to cope with the shortages. Not only the pharma industry, but the academia, regulatory bodies and the Indian government, all are working together towards vaccine development and availability i.e., relaxation in regulatory framework or fast-track approval process for covid essential products, organizing vaccination drives and vaccination centers.


COVID vaccines are being developed and distributed to market within a much shorter time-period against an estimated 8-11 years that a usual candidate drug/ vaccine takes to reach the market. Thus, the need of the hour is a rapid and strict vigilance over the journey of COVID Vaccines from lab to masses, further post-marketing monitoring of safety and efficacy parameters of administered new vaccines.

The vaccine candidate once developed in a lab has to pass through rigorous efficacy, safety, quality and stability screening parameters before it reaches the market. The safety and efficacy data from preclinical (animal study) and clinical trials of vaccine candidates are further examined by the drug regulator of the country before granting the license for the same. Hence, all COVID-19 vaccines that receive license will have comparable safety and efficacy profile.

The Central Drugs Standard Control Organization (CDSCO) is the drug regulator of our country under the Drugs and Cosmetics (D&C) Act, 1940 and the New Drugs & Clinical Trials (NDCT) Rules, 2019. The CDSCO has been empowered a) to grant approval for conducting non-clinical and clinical trials; b) to grant manufacturing, imports, sale, and distribution license to vaccine manufacturer; and c) to conduct inspection of the approved products, manufacturing facilities and labs for quality compliances if need be.

In order to fight the pandemic, CDSCO has come-up with an accelerated regulatory approval policy which aims to conduct review and examination of COVID related vaccines and drugs applications on priority basis without compromising on safety aspects. The accelerated approval process does not mandate bridging study to be performed on local population which is generally required for new drug/vaccine applications under D&C Act. For example, the Serum Institute of India (Covishield), Bharat Biotech (Covaxin) and Zydus Cadila (ZyCoV-D) have already received approval for their vaccines under this policy.

CDSCO has also introduced a provision of "Restricted Use at Emergency Situation" which is similar to USFDA's and UK's "Emergency Use Authorization (EUA)". As per this provision medical products for management of COVID-19 already approved by drug regulators like USFDA, EMA, UK MHRA, PMDA or listed in WHO Emergency Use Listing (EUL), may be granted approval in India under 'Restricted Use at Emergency Situation'. It further prescribes the assessment of safety profile for seven days on the first 100 beneficiaries of such vaccines before it joins the immunization programme1.

CDSCO also monitors the licensed vaccines throughout its product development cycle. One such step is the confirmation over quality and stability of vaccines for every imported and manufactured batch which is performed via 'independent batch release testing' by the Central Drugs Testing Laboratories before it goes to the market.

Further, vaccine safety and stability during storage, transportation and delivery of vaccine is also managed by the central and regional health officials via cold chain assessments and gap analysis performed at various levels. Cold chain management for COVID-19 vaccines will vary depending on the type of the vaccine, as different vaccines have different storage temperature ranges. Cold chain handlers, and vaccinators at all levels are mandated to comply with the Health Ministry's OPERATIONAL GUIDELINES to ensure safety of vaccine and logistics management so that there are no leakages in the delivery system.

Further, once the targeted population is inoculated with a Covid vaccine, a follow-up study or post-marketing surveillance including assessment of Adverse Events Following Immunization (AEFI) has been incorporated in the vaccination protocol by the government. To ensure efficacy and safety of vaccine and the immunization programme, states/ UTs must rapidly detect and promptly respond to all AEFIs through surveillance and action for events following vaccination (SAFEVAC) which has been integrated with the Co-WIN software.


Despite all efforts and exceptions created by the government to accelerate the process of vaccination, the gap between the exponential demand of vaccine and supply thereof is still large. There is a high burden on vaccine manufacturers as still only a few are capable of producing and supplying the vaccines. A mass production and adequate supply of medical products is required to counter this global pandemic. Just like any emergent situation, large quantities, timely delivery and high quality are all of prime essence. Government will have to keep striving to increase the momentum of production & distribution of vaccines while at the same time have proper checks and balances in place for quality and corrections where needed.



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