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Implementing the new GMP standard by 36 drug controllers in states and UTs is crucial, along with ensuring transparency and regulator accountability. India s trading partners, such as Gambia and Nigeria, have heightened scrutiny of Indian drug imports due to quality issues.
According to the joint investigation report, the manufacturing facilities for potent drugs such as sex hormones and beta-lactam are common with general drug category products. The inspectors also found that the incoming materials were not always purchased from approved vendors
According to the joint investigation report, the manufacturing facilities for potent drugs such as sex hormones and beta-lactam are common with general drug category products. The inspectors also found that the incoming materials were not always purchased from approved vendors
As part of the proposal, the government plans to amend the Drug Rules, 1945 to bring alcohol-based drug formulations under Schedule H1 from existing Schedule K drugs.