India’s 1st indigenously developed pneumonia vaccine gets DCGI nod
PTI, Jul 15, 2020, 9:22 PM IST
New Delhi: The country’s first fully indigenously developed vaccine against pneumonia has got approval from the Drug Controller General of India (DCGI), the Union health ministry said on Wednesday.
With the help of Special Expert Committee (SEC) for vaccines, the drug regulator reviewed the phase I, II and III clinical trial data submitted by Pune-based firm Serum Institute of India and then granted the market approval for Pneumococcal Polysaccharide Conjugate Vaccine.
The vaccine is administered in an intramuscular manner.
The ministry said the vaccine will be used for active immunisation against invasive disease and pneumonia caused by ‘Streptococcus pneumonia’ among infants.
The Serum Institute of India first obtained the approval of the DCGI to conduct Phase I, II and III clinical trials of the vaccine in India. These trials have since been concluded within the country. The company also conducted clinical trials in the Gambia.
Thereafter, the company applied for approval and permission to manufacture the vaccine.
The Special Expert Committee (SEC) recommended for grant of permission of market authorization to the said vaccine. On July 14, Serum Institute of India Pvt Ltd was granted permission to manufacture domestically developed first Pneumococcal Polysaccharide Conjugate Vaccine, the ministry said.
“This is the first indigenously developed vaccine in the field of pneumonia,” it said.
Earlier, the demand for such vaccine was substantially met by licensed importers in the country since the manufacturers were all vaccine companies based outside India, the ministry added.
Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.
Top News
Related Articles More
Delhi court extends judicial custody of Kejriwal, K Kavitha in excise policy case till May 7
Former Punjab Congress MLA Angad Saini injured in road accident in Balachaur
Congress cheated Himachal Pradesh with false promises: Union minister Anurag Thakur
PM slams Congress over its Goa leader’s remark on Constitution, says it’s ploy to break country
Anybody who abuses PM Modi won’t be allowed to return home: Rane warns opposition
MUST WATCH
Latest Additions
Delhi court extends judicial custody of Kejriwal, K Kavitha in excise policy case till May 7
Former Punjab Congress MLA Angad Saini injured in road accident in Balachaur
Country’s biggest leader given up morality, does not walk on path of truth: Priyanka Gandhi on PM
Congress cheated Himachal Pradesh with false promises: Union minister Anurag Thakur
BJP demands CBI probe into murder of Hubballi student