DCGI issues new guidelines for pharmaceutical companies working on COVID-19 vaccine

Fresh guidelines have been issued for pharmaceutical companies developing COVID-19 vaccine by DCGI (Drugs Controller General of India). se new guidelines focus on immugenicity, safety and efficacy parameters of vaccine.

Under new DCGI rules a COVID-19 vaccine trial candidate should have a minimum of 50% efficacy in Phase 3 trials and eugh data to understand potential risk associated with ERD (Enhanced Respiratory Disease) to be utilised. DCGI also requires COVID-19 vaccine to be 'well-characterized and manufactured consistently' and to 'remain stable at recommended stor conditions for duration of clinical trial during clinical development st and throughout its shelf life post-approval'.

Pharma giants have also been instructed to study and ensure safety of vaccine in pregnant women as well as its impact on reproductive system.

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New DCGI guidelines for COVID-19 vaccine

Under draft regulatory guidelines issued by DCGI, companies should 'include any planned interim analyses, which should be adequately addressed in terms of purpose, timing, and any statistical adjustments required'. It also clearly states that if COVID-19 vaccine trial fails to meet adequate safety criteria, it's clinical impact should be analysed before commencement of clinical development. During clinical trials and development, impact of vaccine on pregnant candidates as well as pregnancy outcomes should be studied carefully. 

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draft also suggests that once COVID-19 vaccine candidate is developed, routes of administration of vaccine should be studied like intranasal, intradermal, rectal, oral and intravaginal methods. This will aid in understanding its potency in terms of immugenicity, tolerability, toxicity and safety depending on different administration methods. In ar recommendation, pharma companies have been told to utilise an independent data safety monitoring board (DSMB) for vaccine-associated ERD along with or safety signal monitoring.

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Speaking about efficacy of COVID vaccine, ICMR Director-General, Dr Balram Bhargav said, "re are three things for a vaccine--(i) safety, (ii) immugenicity, and (iii) efficacy. Even, WHO says that if we can get more than 50 per cent efficacy that is an accepted vaccine. For respiratory viruses, we never get 100 per cent efficacy. We are aiming for 100 per cent efficacy but may get 50-100 per cent."

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(With inputs from ANI)