The Drug Controller General of India (DCGI) is responsible for approval of licenses of specified categories of drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera. He or she is the head of the CDSCO – the government body responsible for approval of new drugs, clinical trials in the country, laying down the standard for drugs, control over the quality of imparted drugs, coordination with various state organizations and providing advice to maintain uniformity in the enforcement of the Drugs and Cosmetics Act.
The crackdown came after the Drug Controller General of India (DCGI) inspected 76 pharmaceutical companies.
The PCV14 vaccine will be another essential paediatric vaccine in India. It will be administered to infants in 3 doses at 6, 10 and 14 weeks of age.
Covovax vaccine has already been approved for restricted use in adults and children in the 12-17 age group.
Bharat Biotech had sought permission from DCGI to conduct the phase-3 study in December 2021. The trials would be conducted at nine different sites, including AIIMS Delhi.
Zydus' plasmid DNA vaccine can be administered to adults and adolescents in the 12 to 18 years age group, if approved.
DCGI gives approval to develop and manufacture biological tissues
Only 21 out of 370 cases of death due to clinical trials compensated
‘436 died during clinical trials last year’
India's drug control body's hall of shame
Can ethical committees stop illegal clinical trials?
'Drug regulator CDSCO needs to be regulated'
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Ranbaxy gets assistance from the health ministry
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Ranbaxy spurious drugs case: Indian pharma laws different from that of USFDA
No proposal to launch Tb drug Bedaquiline: Azad
'India conducted only 2,010 clinical trials'
Biocon receives marketing approval for its Psoriasis drug in India
Govt working on methods to curb spurious drugs: Health Ministry
12th Five Year Plan to focus on drug regulation
CDSCO looks to crackdown on illegal drug sales
Pharma companies must submit safety records every 6 months
The crackdown came after the Drug Controller General of India (DCGI) inspected 76 pharmaceutical companies.
The PCV14 vaccine will be another essential paediatric vaccine in India. It will be administered to infants in 3 doses at 6, 10 and 14 weeks of age.
Covovax vaccine has already been approved for restricted use in adults and children in the 12-17 age group.
Bharat Biotech had sought permission from DCGI to conduct the phase-3 study in December 2021. The trials would be conducted at nine different sites, including AIIMS Delhi.
Zydus' plasmid DNA vaccine can be administered to adults and adolescents in the 12 to 18 years age group, if approved.
DCGI gives approval to develop and manufacture biological tissues
Only 21 out of 370 cases of death due to clinical trials compensated
‘436 died during clinical trials last year’
India's drug control body's hall of shame
Can ethical committees stop illegal clinical trials?
'Drug regulator CDSCO needs to be regulated'
Is this the end of the Ranbaxy fairytale? Japanese owners thinking of renaming company!
Ranbaxy gets assistance from the health ministry
Ranbaxy spurious drugs update: DCGI probe will take a month, Apollo suspends sales
Ranbaxy spurious drugs case: Indian Medical Association asks DCGI to investigate quality of Ranbaxy drugs in India
Ranbaxy spurious drugs case: Jaslok hospital asks docs not to prescribe Ranbaxy drugs
Ranbaxy spurious drugs case: Indian pharma laws different from that of USFDA
No proposal to launch Tb drug Bedaquiline: Azad
'India conducted only 2,010 clinical trials'
Biocon receives marketing approval for its Psoriasis drug in India
Govt working on methods to curb spurious drugs: Health Ministry
12th Five Year Plan to focus on drug regulation
CDSCO looks to crackdown on illegal drug sales
Pharma companies must submit safety records every 6 months
