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Serum seeks DCGI nod to manufacture Sputnik
SII, applied to Indian regulator, the drugs controller general of India (DCGI), Dr VG Somani, on Wednesday to seek approval for grant of licence.
Serum Institute of India (SII) has sought approval to manufacture the Russian-made coronavirus disease vaccine, Sputnik V, in India, people familiar with the matter said on Thursday.
SII, applied to Indian regulator, the drugs controller general of India (DCGI), Dr VG Somani, on Wednesday to seek approval for grant of licence.
“Yes, it is true that SII has applied to the drugs regulator. They have applied for a test licence,” said one of the people cited above.
A test licence, according to the Central Drugs Standards Control Organisation (CDSCO) website, is granted for the import of small quantities of drugs for purposes of examination, testing or analysis. According to industry insiders, SII is also hoping for grant of indemnity, as is being considered for foreign Covid-19 vaccine makers by the Indian government, as they raised the issue last year.
During Carnegie India’s Global Tech Summit 2020 in December, SII chief executive officer, Adar Poonawalla, talked about the need for the government to provide indemnity to vaccine manufacturers against frivolous complaints.
Sputnik V is currently being distributed in India by Dr Reddy’s Laboratories, which signed a pact with Russian Direct Investment Fund (RDIF) that globally markets the Covid-19 vaccine developed by Russia’s Gamaleya Institute. As part of the deal, Dr Reddy’s will distribute the first 250 million doses of Sputnik V.
RDIF has also tied up with six other local companies to produce its vaccine, and its chief executive officer, Kirill Dmitriev, said earlier that it was also in talks with other manufacturers to ramp up production in India, which is likely to start some time in July. By current estimates, RDIF is looking at a production capacity of about 850 million Sputnik V vaccine doses per annum from India. The companies with which it has a manufacturing tie-up include Hetero Biopharma, Gland Pharma, Stelis Biopharma, Panacea Biotec, and Virchow Biotech.
India granted emergency use authorisation to Sputnik V on April 13.
Queries to SII remained unanswered till press time, and RDIF representatives said as of now there was no official information that they could provide.
SII Is already manufacturing the Oxford-AstraZeneca Covid-19 vaccine locally under the brand name Covishield, which is one of the two jabs being used under the national Covid-19 immunisation programme.
Government officials aware of the matter recently said SII has informed that the company is ramping up its vaccine production capacity, and will likely produce 100-120 million doses a month by June.
SII has also started manufacturing and stockpiling the United States’ Novavax vaccine that it will be locally manufacturing under the brand name Covovax. However, regulatory approval for Novavax is still awaited in the United States.
