News Muncher - category dcgi

1 month ago

DCGI asks cosmetics industry to follow regulatory protocol, avoid making ’unusual claims’; importers complain

New Delhi: The Drugs Controller General of India has directed the cosmetics industry to follow regulatory protocols, and warned against making “unusual claims” to younger-looking skin that overlap the pharmaceutical sector. In a meeting held with the cosmetics industry, stakeholders appealed for easing strict regulatory protocols for imported products. Cosmetics, as per the law, are defined as any article “intended …

India Industry Regulatory Cosmetic Dcgi Cosmetics Cosmetics Industry

1 month, 2 weeks ago

Apex drug regulator to more than double staff strength with 250 new positions in effort to help enforce quality norms

Live Mint

New Delhi: The government plans to more than double staffing at the Central Drugs Standard Control Organization by filling 250 new positions to strengthen enforcement of good manufacturing practices for medicines, vaccines and medical devices, two people aware of the development said. In addition, an additional drugs controller will be appointed for the first time at the country’s apex drug …

India Medical Drugs Medical Devices Indian Drug Devices

1 month, 2 weeks ago

DCGI frames rules for safety, quality of imported cosmetics

Live Mint

New Delhi: No cosmetics can be imported unless the 'use-by' date is at least six months from the date of import, the Drugs Controller General of India said. The regulator, issuing instructions for importing cosmetics, also banned imports of cosmetic containing hexachlorophene and those that have been tested on animals after 12 November 2014. Earlier, Mint reported that DCGI has …

India Cosmetic Dcgi Frames

2 months, 3 weeks ago

Eye drop not intended to replace reading glasses, ENTOD pharma clarifies after DCGI suspension

New Indian Express

NEW DELHI: Days after India’s drug regulator suspended manufacturing and marketing permission of Mumbai-based ETOD Pharmaceuticals, which had claimed that their new eye drop reduced dependency on reading glasses for those suffering from presbyopia, an age-related vision condition, on Thursday clarified that it is a “therapeutic option, available only by prescription from the registered medical practitioner.” This paper was the …

India Reading Company Eye Drop Drug Rti

3 months, 1 week ago

Drug regulator suspends product PresVu over unauthorised promotion

Hindustan Times

The Drugs Controller General of India on Wednesday suspended the product PresVu produced by Entod Pharmaceuticals after the company failed to respond to the queries on the product for which the DGCI says no approval was granted. "Taking serious note of the unauthorised promotion of the product, PresVu by M/s Entod Pharmaceuticals Ltd, after getting permission from CDSCO to manufacture …

India Pharmaceuticals Claims Company Eye Product Drops

3 months, 1 week ago

Drug regulator suspends manufacturing and selling of Entod pharma's eye drops over unapproved claims

India TV News

The DCGI has halted the authorization given to Mumbai-based Entod Pharmaceuticals to produce and market its novel eye drops, citing the company's assertions that it can assist individuals with presbyopia in becoming less reliant on reading glasses. In response to the claim "first eye drop in India designed to reduce the need for reading glasses", the order stated that the …

India Order Company Eye Approved Presbyopia Dcgi

3 months, 1 week ago

Drug regulator suspends pharma firm from manufacturing eye drops claiming to replace reading glasses

New Indian Express

NEW DELHI: India’s drug regulator has suspended manufacturing and marketing permission of Mumbai-based ETOD Pharmaceuticals, which had claimed that their new eye drop could help people reduce dependency on reading glasses for those suffering from presbyopia, an age-related vision condition. The Central Drugs Standard Control Organisation had earlier granted the pharma company approval to manufacture and market their eye drop, …

India Drug Dcgi

3 months, 1 week ago

DCGI suspends Entod’s marketing approval for PresVu eye drops amid misuse concerns

Hindustan Times

The Drugs Controller General of India has suspended the approval granted to Mumbai-based Entod Pharmaceuticals for manufacturing and sale of its eye drops— PresVu— for aggressively overselling the benefits of the product amid concerns of misuse by masses attempting to buy the prescription drug over-the-counter. “… considering the public interest, the permission dated 20.08.2024 issued to manufacture and market of …

India Drugs Vision Company Eye Approval Approved

5 months, 2 weeks ago

‘Insulin’ homoeopathic tablets under CDSCO lens

The Hindu

The Central Drugs Standard Control Organisation has sought a review of the licence given to ‘Insulin tablets’, a homoeopathic medicine. Subsequently, the DCGI found the labelling violating Section 106A of the Drugs and Cosmetics Rules, 1945, which says no homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label. Later, the Ministry found that the manufacturer …

Rajasthan Drugs Babu Insulin Tablets Dcgi Label

5 months, 3 weeks ago

DCGI inspection brings curtains down on 36% of 400 pharma units; plans for new digital projects

Live Mint

Mumbai: The Drug Controller General of India Rajeev Raghuvanshi on Thursday revealed that the Central Drugs Standard Control Organization has conducted risk-based inspections of over 400 pharmaceutical manufacturing units over the past year and a half, resulting in the closure of 36% of these facilities. “We have been successfully doing risk-based inspections and inspected about 400 manufacturing units and I …

India Drugs Quality Regulatory Pharma Ipc Drug

6 months, 1 week ago

Ayush ministry, Raj govt yet to act against firm selling homoeopathic ‘insulin'

New Indian Express

NEW DELHI: Despite clear directions from India's drug regulator, the Ayush Ministry and the Rajasthan government have yet to act against a pharma company selling a homoeopathic medicine named ‘insulin’. The Rajasthan-based company was found to be selling a homoeopathic tablet named ‘insulin,' which had nothing to do with the actual insulin that controls diabetes. According to Babu, despite clear …

India Rajasthan Babu Act Raj Dcgi Homoeopathic Insulin

7 months ago

DCGI orders withdrawal of cancer drug Olaparib for certain treatments

Hindustan Times

New Delhi, The Drug Controller General of India has asked drug regulators in all states and Union territories to withdraw AstraZeneca's anti-cancer drug Olaparib tablets for treatment in patients who have received three or more prior lines of chemotherapy. HT Image State regulators have been asked to direct manufacturers of the drug to discontinue marketing of the drug for the …

Cancer Treatment Drug Dcgi Olaparib Olaparib Tablets

7 months ago

DCGI calls for strict reporting of side-effects related to medical devices

The Hindu

The Drugs Controller General of India has called for timely reporting of adverse events related to medical devices and directed all medical device licence holders and manufacturers to report any adverse events related to life-saving medical equipment on the government’s Materiovigilance Programme of India platform stating that the move is vital to mitigate risks and safeguard public health. The MvPI …

India Medical Medical Devices Devices Adverse Mvpi Events Related

1 year ago

CDSCO set to ban these common cold, flu syrups for children under four years; pharma companies to issue warning on meds

Hindustan Times

The Central Drugs Standard Control Organisation is set to implement a ban on a widely used anti-cold cocktail medicine combination for infants and children under four years of age. Following the committee's recommendation on June 6, 2023, the Drug Controller General of India chief Dr. Rajeev Singh Raghuvanshi issued a letter on December 18, instructing all manufacturers of the common …

Children Drug Cold Four Years Dcgi Fdc Combination

1 year, 3 months ago

Abbott India recalls batches of Digene manufactured at Goa facility after customer complaint: Details

Op India

The Mumbai-based drug manufacturing company, Abbott India is recalling several batches of its popular antacid ‘Digene syrup’, as per reports. Citing a customer complaint, the DCGI letter stated, “On 9th August 2023, one bottle of Digene Gel Mint flavour used by the customer is of regular taste and light pink colour whereas another bottle of same batch observed it was …

India Goa Recall Drug Complaint Facility Letter

1 year, 5 months ago

DCGI issues alert for Pholcodine containing cough syrups; asks doctors to prescribe alternative medicines

Hindustan Times

The Drugs Controller General of India has issued an alert for Pholcodine containing cough and cold remedies and advised doctors and patients to stop consuming any drug containing the chemical. DCGI has asked doctors to advise patients to stop taking pholcodine containing cough syrups and cold remedies and suggest an alternative to treat their symptoms. The statement by DCGI noted …

Dcgi Cough Containing Pholcodine Cold Remedies

1 year, 5 months ago

Regulation for all medical devices from October 1, says DCGI

The Hindu

India is on course to introduce regulations governing all the medical devices in the country on October 1. From October 1, regulations will be in place for the remaining medical devices, categorised under two more groups, the Drugs Controller General of India Rajeev Singh Raghuvanshi said here on Wednesday. An emerging sector, medical devices manufacturing is on the rise spurred …

India Medical Devices

1 year, 6 months ago

Letter to DCGI seeks emergency use nod for investigational antibiotics to save lives

The Hindu

Intensivists and infectious diseases specialists, faced with a dire situation where effective antibiotics to treat drug-resistant infections are lacking, have called on the government to allow emergency use authorisation, as successfully done during the COVID-19 pandemic, for certain life-saving drugs. Unfortunately, by the time we receive compassionate use permission to procure investigational antibiotics in phase 3 or licensed antibiotics from …

India Antibiotics Dcgi Eua Ghafur

1 year, 6 months ago

'Himachal's Baddi Becoming 'Hub' Of Spurious Drugs': NHRC Notice To Health Ministry, DCGI And FSSAI

ABP News

The National Human Rights Commission issued a notice to the Union Health and Family Welfare Ministry, the Food Safety and Standards Authority of India, and the Drugs Controller General of India on Friday in response to a media report that the Baddi Industrial area of Solan in Himachal Pradesh has become a production hub for spurious vitamins, syrups, and drugs …

Food Drugs Companies State Fssai Himachal Pradesh Himachal

1 year, 6 months ago

Test cough syrups meant for exports on priority: DCGI

Hindustan Times

The Drugs Controller General of India on Wednesday directed state drugs regulators and government laboratories to test cough syrup samples meant for exports “on top priority” and issue reports at the earliest, according to people familiar with the matter. “The state drugs controllers are hereby requested to give instructions to your state owned NABL laboratories to analyse the samples received …

India Drugs Test Export Issued Cough Syrup

1 year, 8 months ago

Drugs Controller Told to Filter Out ‘Cocktail Drugs’ from Indian Market, Ban Likely Soon

News 18

The central government has told the country’s apex drugs controller to regulate the market of fixed-dose combination drugs in India – an issue pending for several months now. The Central Drugs Standard Control Organisation, the office of the Drugs Controller General of India, has already started working on this and the ban on these “cocktail drugs” may be announced within …

India Drugs Ministry Ban Cocktail Medicines Dcgi

1 year, 8 months ago

Covovax to be available on CoWIN as booster dose soon. Check details

Hindustan Times

In view of rising cases of COVID-19 in various parts of the country, Union Health Minister Mansukh Mandaviya is learnt to have approved the inclusion of Serum Institute’s Covovax on the CoWIN portal as a heterologous booster dose for adults, official sources said on Monday. According to an official source, Singh had mentioned in his letter to the ministry that …

India Approved Dcgi Dose Covishield Covovax

1 year, 9 months ago

Drug Developed Using DRDO Technology for Radiological and Nuclear Emergencies Gets DCGI Nod

News 18

A critical drug developed on a DRDO technology for radiological and nuclear emergencies has received approval from the Drugs Controller General of India, the defence ministry said on Tuesday. In a statement, the defence ministry said the drug has been developed by the industry based on the technology of Institute of Nuclear Medicine and Allied Sciences, Delhi. ”The manufacturing and …

India Drug Tdf Dcgi Drdo Radiological And Nuclear Emergencies Formulations Developed

1 year, 9 months ago

Critical drug used during nuclear emergencies developed on DRDO tech gets approval

Deccan Chronicle

New Delhi: A critical drug developed on a DRDO technology for radiological and nuclear emergencies has received approval from the Drugs Controller General of India, the defence ministry said on Tuesday. In a statement, the defence ministry said the drug has been developed by the industry based on the technology of Institute of Nuclear Medicine and Allied Sciences, Delhi. "The …

Tdf Dcgi Drdo Defence Ministry Drug Developed Nuclear Emergencies

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Articles for Dcgi

DCGI asks cosmetics industry to follow regulatory protocol, avoid making ’unusual claims’; importers complain

Apex drug regulator to more than double staff strength with 250 new positions in effort to help enforce quality norms

DCGI frames rules for safety, quality of imported cosmetics

Eye drop not intended to replace reading glasses, ENTOD pharma clarifies after DCGI suspension

Drug regulator suspends product PresVu over unauthorised promotion

Drug regulator suspends manufacturing and selling of Entod pharma's eye drops over unapproved claims

Drug regulator suspends pharma firm from manufacturing eye drops claiming to replace reading glasses

DCGI suspends Entod’s marketing approval for PresVu eye drops amid misuse concerns

‘Insulin’ homoeopathic tablets under CDSCO lens

DCGI inspection brings curtains down on 36% of 400 pharma units; plans for new digital projects

Ayush ministry, Raj govt yet to act against firm selling homoeopathic ‘insulin'

DCGI orders withdrawal of cancer drug Olaparib for certain treatments

DCGI calls for strict reporting of side-effects related to medical devices

CDSCO set to ban these common cold, flu syrups for children under four years; pharma companies to issue warning on meds

Abbott India recalls batches of Digene manufactured at Goa facility after customer complaint: Details

DCGI issues alert for Pholcodine containing cough syrups; asks doctors to prescribe alternative medicines

Regulation for all medical devices from October 1, says DCGI

Letter to DCGI seeks emergency use nod for investigational antibiotics to save lives

'Himachal's Baddi Becoming 'Hub' Of Spurious Drugs': NHRC Notice To Health Ministry, DCGI And FSSAI

Test cough syrups meant for exports on priority: DCGI

Drugs Controller Told to Filter Out ‘Cocktail Drugs’ from Indian Market, Ban Likely Soon

Covovax to be available on CoWIN as booster dose soon. Check details

Drug Developed Using DRDO Technology for Radiological and Nuclear Emergencies Gets DCGI Nod

Critical drug used during nuclear emergencies developed on DRDO tech gets approval