Among the listed entities which have been allowed by the CDSCO to manufacture the vaccines for limited use are Serum Institute of India, Cadila Healthcare, Bharat Biotech International Limited, Biological E Limited, Reliance Life Sciences Pvt Limited, Aurbindo Pharma Limited, and Gennova Biopharmaceuticals Limited.
The vaccines will be priced at a maximum of $3 per dose and made available to 92 countries.
Even as the Coronavirus spike continues in India, the Central Drugs Standard Control Organisation (CDSCO) has provided its approval to as many as seven pharma majors to manufacture Covid-19 vaccine for pre-clinical tests, examination, and other related analysis, news agency ANI reported. Among the listed entities which have been allowed by the CDSCO to manufacture the vaccines for limited use are Serum Institute of India, Cadila Healthcare, Bharat Biotech International Limited, Biological E Limited, Reliance Life Sciences Pvt Limited, Aurbindo Pharma Limited, and Gennova Biopharmaceuticals Limited, the Union Health Ministry informed the Lok Sabha as reported by ANI.
The CDSCO also said that the approval procedure and guidelines for clinical trials of the vaccine candidates and their marketing have been enumerated under the New Drugs & Clinical Trials Rules, 2019. In a document released by the Ministry of Health and Family Welfare various steps which have been formulated in consultation with the Indian Council of Medical Research (ICMR) were also enumerated. Ranging from the identification of the right vaccine candidate to conducting pre-clinical trials on small and large animals, the steps also include a detailed procedure for conducting the human trials of the vaccine.
According to the formulated guidelines, every vaccine manufacturer will have to conduct the first phase human trials of the vaccine candidate on up to a hundred volunteers. The number of volunteers should increase up to a 1,000 in the second phase of the trials and up to several thousands in the third and final phase of the human trials respectively, as per the procedure formulated by the ICMR. The process will come to an end after the post-marketing studies on the vaccine have been completed by the manufacturer.
The document released by the Health Ministry also mentioned the manufacturers which are currently conducting human trials of the Coronavirus vaccine under the supervision of the ICMR. A total of three manufacturers are conducting human trials of Covid-19 in the country which include the Serum Institute of India, Cadila Healthcare, and Bharat Biotech International Limited. While Bharat Biotech and Cadila Healthcare are in the second phase human trial stage of their indigenously developed Coronavirus vaccine candidate, the Serum Institute of India is conducting the 2nd and 3rd phase human trials of the vaccine developed by the University of Oxford and AstraZeneca in the UK.