Drug Controller General Of India

Medicines should be sold under supervision of pharmacists in medical stores

India's drug regulator DCGI has written to drug controllers of all states and Union territories and the Pharmacy Council of India asking them to ensure that pharmacists are physically present in retail medical stores and that medicines are sold under their direct supervision. In a letter, Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi sought strict implementation of section 42 (a) of the Pharmacy Act 1947 and Rules 65 of the Drugs and Cosmetics Act 1945 in retail pharmacies. Ensure that pharmacists are physically present in the retail pharmacies/medical stores, and that medicines are sold/dispensed under their direct supervision. Ensure that no prescription medicine is sold/dispensed from the retail medicines shop without a proper and valid prescription," the DCGI said in the letter sent on March 9. The drug regulator referred to a letter from Suresh Khanna, National General Secretary, IPA, Mumbai which highlighted issues pertaining to implementation of Section

AstraZeneca gets CDSCO nod for drug to treat biliary tract cancer

Drug firm AstraZeneca India on Friday said it has received approval from the domestic drug regulator to market a drug to treat biliary tract cancer (BTC) in the country. The company has received approval from the Central Drugs Standard Control Organisation (CDSCO) for Durvalumab, the drug firm said in a statement. BTC is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine). Apart from ampullary cancer, early-stage BTC often presents without clear symptoms and most new cases of BTC are therefore diagnosed at an advanced stage, when treatment options are limited, and the prognosis is poor. More than 30,000 new cases of BTC are seen in India every year with 90 per cent of them diagnosed in the advanced stage. "The approval underpins our commitment to transform patient outcomes by harnessing the power of science

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India's drug regulator serves show-cause notice to online pharmacies

Gives firms two days to respond to allegations that they flouted rules

Eyestem to start first trial in India to treat age-related blindness

The first nine patients that they will inject would be legally blind, as they have to prove safety first

Centre extends tenure of DCGI Dr V G Somani by another three months

The tenure of Dr V G Somani as the Drugs Controller General of India (DCGI) has been again extended by another three months, according to an order issued by the Union Health Ministry. The extension will come into effect from Tuesday, the order said. He was earlier given an extension in August this year. "In continuation to office order dated 16.08.2022, the competent authority has concurred approval for Dr V G Somani, to continue to hold the charge of the post of Drugs Controller of (India) for a further period of three months w.e.f. 16.11.2022 or until further order, whichever is earlier," it said. Dr Somani was appointed the DCGI for a term of three years on August 14, 2019. The DCGI heads the Central Drugs Standard Control Organisation (CDSCO), which is responsible for ensuring quality drugs supply across the country.It also has authority to give approval to new drugs and regulate clinical trials.

Largest ever contingent of India Inc participates in GITEX Global 2022

India had the highest number of participating companies after the host, UAE, at the four-day event

India's first nasal vaccine for Covid-19 gets DCGI nod for emergency use

Bharat Biotech's iNCOVACC cleared for 2-dose regimen

India's first indigenous mRNA vax Gemcovac-19 likely to be available soon

Gennova Biopharmaceuticals Ltd aims to produce around 4 - 5 million doses per month and this capacity can be quickly doubled

DCGI approves indigenous mRNA Covid jab for emergency use in adults: Report

It is for the first time ever that Covid-19 vaccine remains stable during storage even at 2-8 degrees Celsius

CBI apprehends some persons over Rs 3 lakh bribery case at DCGI office

The CBI team, after getting inputs about exchange of bribery, allegedly carried out trap operation in which some persons were apprehended, officials said.

Centre's FY22 fiscal deficit at 6.7% vs revised estimates of 6.9%

April saw revenue surplus of Rs 591 crore

'Gennova will soon submit necessary data of mRNA Covid vaccine to DCGI'

The vaccine - GEMCOVAC-19 - is the country's first homegrown mRNA Covid- 19 vaccine and is seen as a game-changer for the healthcare industry.

DCGI emergency use nod for Covaxin, Corbevax and ZyCoV-D across age groups

Covaxin bags approval for 6-12-year age group, Corbevax for 5-12 group, and ZyCoV-D for 12 years and above

Bharat Biotech asked to provide more data on Covaxin for below 12-year-olds

This development comes after the Subject Expert Committee discussed recommendations for the restricted emergency of Covaxin in children aged between 2-12 years

Zydus gets DCGI nod for drug to treat anaemia linked with kidney disease

Zydus Lifesciences on Monday said it has received an approval from the DCGI for Oxemia (Desidustat), a first-of-its-kind oral treatment for anaemia associated with chronic kidney disease

Sputnik Light: SEC recommends permission for phase 3 trial as booster dose

The DCGI had on February 4 granted emergency use permission to Sputnik Light vaccine in India, subject to certain regulatory provisions

Govt panel recommends EUA for Covid vaccine Covovax for 12-17 age group

An expert panel of the country's central drug authority has recommended granting emergency use authorisationto SII's Covid vaccine Covovax for the 12-17 age group, official sources said on Friday.

Corbevax Covid vaccine is safe, offers high antibody levels: NTAGI chief

India's third homegrown COVID-19 vaccine Corbevax is safe and offers good immunogenicity and higher antibody levels than some other vector vaccines: Official

DCGI accords conditional market approval for Covaxin and Covishield

Firms will need to submit data of overseas ongoing clinical trials of their vaccines every 6 months