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DCGI SAFETY ISSUES
Drugmakers must report safety data from launch date, not approval date: CDSCOIndia's drug regulator has issued a new directive for pharmaceutical companies. Periodic Safety Update Reports for new drugs must now be su...- Easy access to weight-loss drugs rings alarm bells among doctors, authorities; regulators step inWeight-loss drugs are being sold without prescriptions in India. This is causing alarm among doctors and authorities. People are buying the...
- DCGI suspends nod to Entod's new eye drops over unapproved 'claims'India's drug regulator has suspended Entod Pharmaceuticals' permission to manufacture and sell PresVu Eye Drops. The company did not obtain...
- ET Impact: DCGI asks pharma cos to adhere to production quality standardsThe DCGI's move comes a few days after ET reported that industrial excipients are used in manufacturing medicines and over 50 companies man...
- DCGI asks states to keep vigil on sale of falsified versions of 2 drugs following WHO alertsThe Drugs Controller General of India (DCGI) has issued an advisory to keep a strict watch on the sale and distribution of falsified versio...
- CDSCO panel recommends emergency use authorisation for SII's Covid vaccine Covovax"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) reviewed the emergency use autho...
- DCGI seeks more data from SII over its application seeking emergency authorisation for CovovaxSerum Institute of India (SII) had sent an application to the DCGI in October for the grant of market authorisation of Covovax for restrict...
- Covid-19: Decision on allowing Serum Institute to resume clinical trials likely todayPharma giant AstraZeneca on Saturday said that the clinical trials for their Oxford Covid vaccine have resumed in the UK following confirma...
- Drug regulator asks Serum Institute to increase safety monitors of Covid drug trialsA day after the company halted the trial of the AstraZeneca-Oxford University Covid vaccine in the country. The Drug controller has asked t...
- DGCI directs Serum Institute to suspend any new recruitment in phase 2, 3 COVID-19 vaccine clinical trialsOn 9 September ANI first reported that DCGI issued a show-cause notice to Serum Institute for not pausing the ongoing clinical trial of the...
- Will follow DCGI order on Oxford Covid vaccine trial: Serum Institute of IndiaThe regulator had issued a show cause notice to SII on Wednesday evening asking it to explain why trials shouldn’t be suspended. SII had sa...
- Govt seeks complaints on ‘dissolving stents’, but has no system to act on itThe Indian Pharmacopoeia Commission in Ghaziabad is the national coordination centre for the materio vigilance programme.
- Indian pharma company may sue drug controller over safety of Novartis painkillerNovartis’ Voveran 1ml and Themis' Aquadol have competed with Troikaa’s own injection to manage pain, Dynapar AQ, since their launch in 2013.
- Government eases norms to test, launch drugsEthics Committee has also been allowed to add trial sites and investigators without the need to obtain a no objection certificate from the ...
- DCGI asks drug manufacturers to get clearance before August 30The drug controller had earlier directed the state drug controllers to withdraw 294 FDCs which got licences without approval of DCGI.
- After Ranbaxy, Wockhardt episodes must for drug cos to disclose global regulators’ actionThis mandate of more stringent disclosures on safety alerts of international drug regulators comes after Ranbaxy and Wockhardt fell foul of...
- DCGI working on policy to respond to safety alerts by foreign regulatorsIndia's drug regulator is working on a policy on how to respond to safety alerts by foreign regulator on medicines manufactured by Indian co
- Delhi HC debarred Generic durgmakers from marketingThe Delhi High Court (HC) has asked the drug controller general of India (DCGI) not to give marketing or manufacturing permission to generi...
- Pharma dept wants drug controller's office under its ambitThe newly-formed department of pharmaceuticals wants to take Drug Controller General of India (DCGI) under its control.
- DCGI likely to invoke special provisions to ban 294 drugsFaced with resistance from drug makers and legal reversals, the Drug Controller General of India (DCGI) will use all means within his comma...
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