Drug regulator seeks more data to pharma companies before giving Emergency Authorisation

After the three Pharma giants have approached the drug regulator asking for EUA of its vaccine to manufacture and marketing in India, the Central Drugs Standard Control Organisation asked them to provide more data related to safety and efficacy of their Covid-19 vaccine candidate.

New Delhi:The Central Drugs Standard Control Organisation (CDSCO) on Wednesday asked Serum Institute of India (SII), Bharat Biotech International Limited and Pfizer Limited to provide more data related to safety and efficacy of their Covid-19 vaccine candidate before giving them Emergency Use Authorisation (EUA) approval in India.

These three Pharma giant have approached the drug regulator asking for EUA of its vaccine to manufacture and marketing in India.

The CDSCO is India's central drug authority which has regulatory control over the import of drugs, approval of new drugs and clinical trials among others.

The Subject Expert Committee (SEC) of the regulator on Wednesday had a detailed review meeting with the representatives of the three pharma giants over the matter.

After having a meeting with the SII representatives, the SEC in a note recommended that the firm should submit updated safety data of phase II and III clinical trial in the country, immunogenicity data from the clinical trial in UK and India, outcome of the assessment of UK-MHRA for grant of EUA for further review.

The SII presented their proposal for grant of EUA of COVISHIELD along with the interim safety data from phase II and III clinical trial carried out in the country and the interim safety and efficacy results of phase II/III and phase III clinical trials carried out in UK, other countries and India before the committee.

The committee noted that as per the condition of the permission to conduct Phase II and III clinical trials in the country, the clinical data generated in the trial shall be considered along with the data from the Oxford clinical trial outcome.

Further, the firm stated that the proposal for grant of emergency use authorisation is currently under evaluation with MHRA. It is also noted that the Phase II/III clinical trial is still going on in the country.

The SEC also asked Bharat Biotech to present the safety and efficacy data from the ongoing Phase III clinical trial in the country for further consideration. Earlier, the firm presented their proposal for grant of EUA of the whole virion, inactivated Coronavirus vaccine (BBV152) along with the interim safety and immunogenicity data of phase I and II clinical trials carried out in the country before the committee.

Significantly, Pfizer whose Covid-19 vaccine has already started tolling in UK, has asked for more time for making a presentation before the committee.

The Pfizer has pitched for its Covid-19 mRNA Vaccine BNT162b2 before the drug regulator.

Another Pune based Pharma giant Gennova Biopharmaceuticals Limited has also approached the drug regulator for grant of permission to conduct Phase I and II clinical trial along with animal toxicity study data before the committee.

"After detailed deliberation, the committee recommended for grant of permission to conduct Phase I and II clinical trials subject to the condition that the interim results of Phase I study shall be submitted to the committee before proceeding to the next phase," the SEC noted.