The step addresses industry worries pertaining to panels’ unneeded cooking and vague examining. An industry professional, talking on problem of anonymity to News18, shared inconvenience over SEC panels posturing pointless inquiries. They mentioned...
Level II are notifiable changes, which are modest top quality changes that have a modest potential to have a damaging impact on the identification, toughness, quality, purity or effectiveness of the biological item....
In February 2023 Global Pharma Healthcare, a Chennai-based company Global Pharma Healthcare found itself in the spotlight of regulators when it was discovered that the US Centers for Disease Control and Prevention (CDC)...
India’s regulator of cosmetics, pharmaceuticals and other medical devices has requested that companies provide an annual statement with information about the cosmetics imported into the country. The Central Drugs Standard Control Organisation’s (CDSCO) move...
In an effort to simplify and rationalize the sampling process and to maintain an omni-channel database of monthly samples, in its efforts to streamline and rationalise the sampling procedure, the Central Drugs Standard...
New initiative by Drug Controller General of India to boost ease of doing business A public notice, published February 14, details plans that will allow for DCGI to host walk-in meetings with the...
Pen drives, emails, and Google Drive — the government’s drug regulatory authority is no longer accepting documents written on paper to grant approvals and manufacturing permits for medicines or devices as well as...
According to official data, in December 2023, the Central Drugs Standard Control Organisation (CDSCO) reported that nearly 7.7 percent of the drug samples it examined were determined to be of substandard quality (NSQ)....
India’s apex medicine regulator, the Central Drugs Requirement Control Organisation (CDSCO), last month advised drugmakers not to offer a prominent fixed dosage mix (FDC) medication, shown as a cough medicine, for youngsters under the age...
