REGULATORY REQUIREMENTS FOR NASAL PRODUCTS AS PER CDSCO IN INDIA COMPARISON WITH GERMANY

Dr. P. Ashok Kumar*, Athiya Rafath, Damini S., Maheshwari B. K., Pavithra M. G., Radhika U.

ABSTRACT

Drugs administered intranasally represent a viable alternative to parenteral delivery, serving as an effective option
for medicines with low oral bioavailability due to gastrointestinal tract degradation or extensive first-pass
metabolism. Enzymatic deactivation is a significant issue for polypeptide medicines; thus, the nasal route—
offering low enzymatic activity and vascularized tissues with strong blood flow—serves as a non-invasive
alternative to injections. The nasal membrane absorbs small drug molecules rapidly, while absorption of larger
molecules can be augmented via mucociliary clearance modulation or permeation enhancers. Beyond systemic
delivery, the nasal route presents opportunities for targeted central nervous system (CNS) transport bypassing the
blood-brain barrier. This review evaluates the anatomical and physiological principles of the nasal cavity,
categorizes drug delivery systems, and compares the regulatory requirements for import, manufacturing, sale, and
export between India (Central Drugs Standard Control Organisation [CDSCO]) and Germany (Federal Institute for
Drugs and Medical Devices [BfArM] / European Medicines Agency [EMA]).

Keywords: Regulatory affairs, CDSCO(Central Drug Standard Control Organisation), EMA(European Medicines Agency).