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Only Processing Charges To Be Levied For Procuring Blood At Hospitals, Blood Banks: Drug Regulator

Hospitals and blood banks can now only charge processing fees for blood as the apex drug regulator has decided to do away with all other fees to check the practice of overcharging.

India , Drugs-consultative-committee , Blood-banks , Drug-regulator , Drugs-controller-general , Drugs-controller-general-of-india , Blood-donation , Dcgi ,

Glenmark Pharmaceuticals: Glenmark launches antidiabetic drug in India

The drug is being marketed under the brand name Lirafit following the approval from the Drug Controller General of India (DCGI), the company said in a statement.

Business-news , Breaking-news-events , Latest-news-updates , Economic-times , Economic-times-news-app , Daily-market-updates , Live-business , Glenmark-pharmaceuticals , Antidiabetic-drug , Liraglutide , Lirafit

Who is responsible at drugmakers? Regulator wants to find out

India’s drug regulator plans to order all drug companies to name a ‘responsible person’ who will be accountable for their day-to-day affairs

Gambia , India , Uzbekistan , Rajeev-singh-raghuvanshi , Cosmetics-act , Drug-regulator , Responsible-person , Drug-controller-general-of-india , Dcgi , Drug-licences , Drugs-and-cosmetics-act

CDSCO uncovers data manipulation, SOP violations by public testing labs

The Central Drugs Standard Control Organisation (CDSCO), along with state drug inspectors, have been doing these inspections as part of a massive nationwide crackdown on spurious and substandard medicines. At present Phase IV of risk based inspections (RBI) is ongoing.

India , Central-drugs-standard-control-organisation , Central-drugs-standards-control-organisation , Quality-management-systems , Drug-controller-general , Cosmetic-rules , Cdsco , Data-manipulation , Sop-violations , Dcgi , Pharmaceutical-companies

ET Impact: DCGI asks pharma cos to adhere to production quality standards

The DCGI's move comes a few days after ET reported that industrial excipients are used in manufacturing medicines and over 50 companies manufacturing cough syrups have failed quality tests. The World Health Organization (WHO) said in October last year that the deaths of dozens of children in Gambia from acute kidney injuries might be linked to contaminated cough and cold syrups made by an Indian drug manufacturer.

Business-news , Breaking-news-events , Latest-news-updates , Economic-times , Economic-times-news-app , Daily-market-updates , Live-business , Pharmaceutical-companies , Production-quality-standards , Manufacturing-licences , Parameters-of-quality

New Drug Launches See 4-Year Lag in India vs US and EU: Lobby of Foreign Drugmakers to DCGI

Launching new drugs in India takes up to a four-year delay compared to the US or the European Union, primarily due to complex clinical trial regulations, the lobby of foreign drugmakers told India’s apex drug regulator, News18 has learnt.

India , Kasauli , Himachal-pradesh , United-states , Astra-zeneca , Central-drugs-laboratory-in-himachal-pradesh-kasauli , Indian-society-of-clinical-research , Organisation-of-pharmaceutical-producers-india , Expert-committee , Novartis , European-union , Drug-controller-general

painkillers: Two painkillers Tapentadol and Pregabalin may go off OTC over misuse

The Drugs Controller General of India (DCGI) is considering banning over-the-counter (OTC) sales of pain relievers Tapentadol and Pregabalin to curb misuse. Pregabalin is prescribed for neuropathic pain and fibromyalgia, while Tapentadol is used for seizures. The DCGI has constituted a sub-committee to review the matter, including experts from the regulator's office, clinicians, and pharmacologists.

India , Drug-consultative-committee , Department-of-revenue , Drugs-controller-general , Control-substances , Painkillers , Otc , Tapentadol , Pregabalin , Dcgi ,

DCGI to meet stakeholders soon to discuss improvements in clinical trials

A meeting to be attended by representatives from the Indian Society for Clinical Research, Organisation of Pharmaceutical Producers of India (OPPI), Indian Pharmaceutical Alliance will be held on November 14. India's drug regulator has received several representations raising concerns on the processing of global clinical trial applications.

Business-news , Breaking-news-events , Latest-news-updates , Economic-times , Economic-times-news-app , Daily-market-updates , Live-business , Global-clinical-trials , Dcgi , Clinical-trials , Drugs-controller-general-of-india

High-risk medical gear makers get more time for licence compliance

The Drugs Controller General of India (DCGI) has announced that manufacturers and importers of high-risk medical devices who have applied for a license before September 30 can continue to supply them in the market for another six months. New regulations state that medical devices in the 'class C' and 'class D' categories cannot be sold without a license. Many manufacturers have applied for licenses but have not received them on time. The government's think tank, NITI Aayog, has recommended that all medical devices meet safety and quality standards.

India , New-delhi , Delhi , Mansukh-mandaviya , Association-of-indian-medical-devices-industry , Central-drugs-standard-control-organisation , Drugs-controller-general , Indian-medical-devices-industry , Niti-aayog , Cdsco , High-risk-devices , Licence-compliance

pharma: DCGI initiates review of pharma manufacturing standards to ensure drug quality and safety

India's drug regulator, the Drug Controller General of India (DCGI), plans to review pharmaceutical manufacturing standards in order to ensure the quality, safety, and efficacy of drugs. The DCGI will meet with pharma industry associations to discuss reviewing Good Manufacturing Practices (GMP) for pharma companies. The government aims to upgrade Schedule M, which lays down GMP, to international standards.

India , Gambia , Kozhikode , Kerala , Mansukh-mandaviya , Offering-college , Drug-administration , European-union , Healthcare-management-analytics-programme , Indian-school-of-business , Organisation-of-pharmaceutical-producers-india , World-health-organization