India Exempts Local Clinical Trials For New Foreign Drugs

The Indian government has announced a streamlined approval process for certain categories of new drugs recognizing approvals from key global regulatory authorities. CDSCO has specified a waiver from local clinical trials for USA, UK, Japan, Australia, Canada, and the European Union (EU).

CDSCO Urges Manufacturers To Implement New Drug Manufacturing Rules

The guidelines outline several key principles to be adhered to by pharmaceutical manufacturers, focusing on pharmaceutical quality systems, quality risk management, sanitation and hygiene, qualification and validation, complaints and adverse reactions, product recalls, and change control. The CDSCO has also advocated for manufacturers to comply particularly with WHO good manufacturing practices for sterile pharmaceutical products.

New Regulations to Ensure Power Grid Stability

The primary goal of these regulations is to discourage deviations from the power schedule, which can lead to grid instability. To achieve this, a commercial mechanism will be implemented to penalize such deviations. All grid-connected entities, including power generators, distributors, and traders, will be subject to these new rules.