By Vidush Pandey

Who grants approval and regulates the vaccine process in India?

The Central Drug Standard Control Organization (CDSCO) is the apex body that regulates the approval of new drugs, vaccines, clinical trials, diagnostic tests, medical devices and issue licenses for commercial sale in India. New Drugs and Clinical Trials Rules 2019 govern the approval process of new drugs or vaccines.

During the pandemic, CDSCO adopted a “rolling review” approach under which the drug regulator evaluates clinical trial data on the vaccine candidate on a real-time basis without having to wait for the entire data to be collated. In a usual scenario, data is reviewed only after all the phases of a trial are completed.

Can phases of trials be skipped while granting approval?

Unlike Emergency Use Authorization (EUA) followed in the USA, India follows the Accelerated Approval Process (AAP) under which a new drug is approved based on data generated in clinical trials. The rules provide relaxation for skipping Phase III clinical trials, which is a crucial test for a vaccine or drug’s efficacy in preventing the spread of disease in the local population. Phase III trial is allowed to be skipped if “remarkable efficacy” is observed with a defined dose in Phase II clinical trial of the new drug.

However, while granting approval the authority used the term restricted emergency use which is nowhere defined in New Drugs and Clinical Trials Rules 2019. Pfizer India, Serum Institute of India (SII) and Bharat Biotech have applied for approval for their vaccines under the accelerated process.

Why are experts concerned?

Experts are concerned with the way Covaxin (which is still in stage III trials), from Bharat Biotech, has been granted the approval. In their view, the lack of data in the public domain and hasty approval makes the case for Covaxin weak. It compromises the principles of trust and transparency which is crucial in administering a smooth and healthy vaccination drive. Experts are demanding full disclosure of information as well rationale behind such approval to Covaxin.

How is the government planning to execute the vaccination drive?

The Health Ministry recently shared the operational guidelines for the vaccination drive. Key highlights are:

1. The COVID Vaccine Intelligence Network (Co-WIN) system — a digitalised platform — will be used to track enlisted beneficiaries for the vaccination and anti-coronavirus vaccines on a real-time basis.
2. All measures should be taken to avoid exposing the vaccine carrier, vaccine vials or ice packs to direct sunlight.
3. The vaccination team will consist of five members.. Each session should be planned for 100 beneficiaries per day. If the session site has adequate logistics and space available for the waiting room and observation room along with arrangement for crowd management, one more vaccinator officer can be added to create a session for 200 beneficiaries.
4. The latest electoral roll for Lok Sabha and legislative assembly election will be used to identify the population aged 50 years or more.
5. Twelve photo-identity documents, including Voter ID, Aadhar card, driving license, passport and pension document, will be required for self-registration on the Co-WIN website.

(Writer is a lawyer and an independent researcher)

Featured Image Source: Times of India

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