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Manufacturing approval granted for three indigenous Mpox testing kits
These RT-PCR kits, which utilise fluid samples from pox rashes to detect the virus, were validated by the Indian Council of Medical Research (ICMR). Read more
CDSCO mandates GMP compliance for sterile equipment manufacturers
This move marks a significant shift, as GMP compliance was previously required only for drug manufacturers.Read more
CDSCO shuts down 36% of drug manufacturing units for failing quality standards
India has around 10,000 pharma manufacturing units, of which nearly 80 per cent are micro-small and medium-scale facilities. Read more
India improves quality assurance for pharma exports; matches WHO norms
The overhaul of the approvals process for pharmaceutical exports is a concerted effort by India to address global concerns and boost confidence in the quality and safety of its pharmaceutical products in the international market.Read more
India cracks down on pharma: 76 companies ordered to halt production over poor standards
Show cause notices have been issued to over 75% of these companies, the insiders revealed. Of the samples collected from these manufacturing units, 15.1% have been identified as not meeting standard quality (NSQ) criteria.Read more
Indian medical device makers seek extension for Class C, D device licensing
The Association of Indian Medical Device Industry (AiMED), representing domestic medical device makers, sent a letter dated September 25 to Health Minister Mansukh Mandaviya, outlining their concerns.Read more
TUV Rheinland to audit medical device facilities in India
The company has been appointed a notified body by the Central Drugs Standard Control Organisation (CDSCO)Read more