The Central Drug Standard Control Organization (CDSCO) is preparing to issue alerts regarding vaccines, focusing on potential impacts on infants when administered to breastfeeding mothers. These alerts will urge parents to promptly report any unusual reactions observed in their babies after exposure to breast milk, aiming to assess whether vaccines received by mothers might be causing side effects in their infants. The guidelines are nearing finalization, emphasizing the need for comprehensive data collection even when pregnant women do not display immediate side effects from experimental drugs.
Serious adverse effects are required to be reported to the licensing authority within 15 days. State drug regulatory authorities are mandated to task drug inspectors with collecting suspicious vaccine samples for analysis at the Central Drugs Laboratory in Kasauli. Furthermore, CDSCO mandates the appointment of specialized pharmacy intelligence officers within vaccine-producing or importing companies to enhance oversight and compliance.
