National: The Central Drugs Standard Control Organisation (CDSCO) has officially prohibited using a commonly used anti-cold medicine combination for infants and children under the age of four. In response to numerous complaints received by the CDSCO regarding the Fixed Dose Combination (FDC), the regulatory body has taken decisive action to ensure the safety of young children.
The banned FDC, composed of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5mg per ml drops, has been a subject of concern due to reported global incidents linking it to the deaths of over 140 children. Chlorpheniramine Maleate is an anti-allergic drug, while Phenylephrine is known as a decongestant. Following an extensive evaluation and discussion within the CDSCO's Subject Expert Committee (SEC), which involved a specially invited paediatrician, a decision was reached to restrict the usage of this FDC in children below four years of age.
The SEC's recommendation, backed by expert opinions, led the Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi, to issue a directive on December 18. This directive mandates all manufacturers of the common cold FDC to include a prominent warning on the label and package insert, advising against its use for children under four years old.
The SEC, a key advisory body to the CDSCO, guides on various matters, including new drug substances and fixed-dose combinations, underscoring its pivotal role in shaping regulatory decisions in the pharmaceutical domain. As per the latest directive from the DCGI, pharmaceutical manufacturers must adhere to the mandated warning on the label and package insert to ensure compliance with the ban on this specific FDC for young children.
Highlighting the collaborative nature of this decision-making process, an official emphasised that the CDSCO continuously takes action upon receiving complaints, guided by recommendations from the SEC. This move reflects the commitment of regulatory authorities to prioritise children's safety and well-being in pharmaceutical products.
This regulatory action signifies a proactive step taken by the CDSCO to address safety concerns associated with using specific medicine combinations, underscoring the importance of stringent oversight and caution in pediatric pharmaceuticals.
Read More:
