Dcgi

Bajaj Health has also extended the offer for Pimavanserin to several leading pharma companies to ensure availability in Indian market. The company said it has a 'strong manufacturing expertise' which it aims to leverage.

ENTOD Pharma appeals to DCGI over suspension, says PresVu eye drops do not replace reading glasses

ENTOD Pharma met Drug Controller General of India (DCGI) officials earlier this week, and informed the regulator that PresVu eye drops were not intended to replace reading glasses, or non-invasive options, for presbyopia.

DCGI suspends nod for Entod's eye drop, company says will challenge the order

The DCGI order, reviewed by Moneycontrol, said the company did not obtain any prior approval from the Central Licencing Authority to make such claims for the product.

Explained: What's Novartis' new anti-cholesterol jab all about

Novartis India is poised to launch its groundbreaking twice-a-year cholesterol jab, Inclisiran, in January. 

DCGI temporarily defers inspection of labs to focus on cough syrup companies

The issues with poor-quality cough syrups started when Indian manufactured cough syrups we allegedly linked to the deaths of children in Gambia and Uzbekistan

Hero MotoCorp faces tax probe over links to vendor, say sources

Based on the alleged fake spending by vendor Salt Experiences, Hero MotoCorp received a tax credit, leading to suspected tax evasion of about 160 million rupees, one of the two sources said, speaking on condition of anonymity.

Cough syrup samples for export piling up at govt labs, Centre looks to rope in private facilities

Rajeev Singh Raghuvanshi, Drug Controller General of India, in two separate communications to drug exporters, informed about the pendency of more than 100 cough syrups for analysis in Ghaziabad and Mumbai testing facilities, requesting them not to send the samples to these labs.

Drug quality concerns take centre stage at pharma export council’s global meet

Rajeev Raghuvanshi, DCGI, said that the non-uniform implementation of the Drugs and Cosmetics Act in the states was a challenge, but added that there was room for improvement.

Akums' anti-seizure medicine for treating epilepsy gets DCGI nod

The Perampanel Oral Suspension is a bioequivalent formulation to the US FDA-approved FYCOMPA Oral Suspension

Mandatory testing of cough syrup before exports, DCGI asks labs to give top priority to such samples

Cough syrup exporters will have to produce a certificate of analysis issued by a government laboratory before the product is exported, effective June 1, the Directorate General of Foreign Trade (DGFT) said in a notification on Monday.

Drug regulators crack down on companies making substandard medicines

Under the drive, licences of 18 firms have either been cancelled or suspended.

Government seeks legal opinion to draft regulations on e-pharmacies' operations

Drugs Controller General of India had issued show cause notices to over 20 e-pharmacies. These e-pharmacies have sought time from the government to respond to the notices.

Takeda working with Indian government, regulator to bring dengue vaccine

‘We are very optimistic for India and the opportunity is still there. We need to work collaboratively with the government and different stakeholders on this,” Mahender Nayak, head of Asia Pacific, Takeda Pharmaceuticals, tells Moneycontrol

Challenges galore as new DCGI takes charge

Rajeev Singh Raghuvanshi takes over as DCGI at a time when India's pharma industry is facing a major credibility issue worldwide due to allegations of supplying substandard products

Why DCGI served a show-cause notice on e-pharmacies

Online pharmacies do not comply with licence conditions like selling against a prescription, maintaining records about the sale of Schedule H drugs, and more, which can lead to drug abuse and self-medication.

Moneycontrol Selects: Top stories this evening

Our specially curated package of the most interesting articles to help you stay at the top of your game.

Tata 1mg, Flipkart, Amazon among 20 e-pharmacies served DGCI notice for violating drug rules

The DGCI has said that even after the instructions from apex regulator for compliance of the order of Delhi High Court, the e-pharmacies were found to be engaged in selling medicines online without license.

Is uniform implementation of drug approval system a possibility in India?

In 2003, the RA Mashelkar Committee said that a strong, well-equipped, empowered, independent and professionally-managed CDSCO, which could be given the status of Central Drug Administration, reporting directly to the Ministry of Health would be the most appropriate solution.

DCGI approves market authorisation for SII's Covid vaccine Covovax as heterologous booster dose

The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO).

DCGI gives nod to SII-manufactured Ebola vaccine for export to Uganda

The vaccine has been developed by Serum Institute in collaboration with Oxford University, UK. According to sources, this vaccine will be used for solidarity clinical trials in Uganda.

Health ministry trashes reports of hasty approval to Covaxin under political pressure

Bharat Biotech said company faced no external pressure to accelerate development of Covaxin, adding they had an internal pressure to develop a safe, and effective vaccine for the Covid-19 pandemic, to save lives and livelihoods in India and globally.

Gambian cough syrup deaths: Health ministry forms four member panel

The committee will also advise and recommend DCGI about further course of action.

Delhi HC grants bail to Eswara Reddy, Pravin Kumar in CDSCO bribery case, says no flight risk

The judge said the trial in the matter would take ample time and noted that the credibility of circumstantial evidence in the case would have to be assessed.

Johnson & Johnson won’t take controversial baby powder off shelves in India

While experts questioned the company’s decision not to immediately withdraw the product that’s said to contain cancer-causing asbestos, the Indian drug regulator is silent.

AstraZeneca India receives DCGI's nod to market drug treating breast cancer

The Drugs Controller General of India (DCGI) has approved Lynparza (Olaparib) as a monotherapy for the treatment of adult patients with early breast cancer.