Context
- The Central Drugs Standard Control Organisation (CDSCO) recently called for the rational, safe and responsible use of non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics.
- It highlighted concerns over indiscriminate use of these medicines and associated risks, including chronic kidney disease (CKD).
- The development underlines an important regulatory principle: drug safety extends beyond market approval to how medicines are prescribed, consumed and monitored.
What Is CDSCO?
- CDSCO is India’s National Regulatory Authority (NRA) for drugs, medical devices and cosmetics.
- It functions under the Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare.
- Headquartered in New Delhi, it is headed by the Drugs Controller General of India (DCGI).
- Its regulatory responsibilities primarily arise from the Drugs and Cosmetics Act, 1940 and Rules, 1945, along with subsequent regulatory frameworks.
Its core objective is to protect public health by ensuring the safety, efficacy and quality of regulated medical products.
Major Functions of CDSCO
- New drugs and clinical trials: Regulates approval of new drugs and clinical trials to evaluate their safety and efficacy before wider use.
- Drug standards and imports: Lays down drug standards and exercises regulatory control over the quality of imported drugs.
- Medical devices: Regulates medical devices under the applicable framework, including functions relating to their import, manufacture and clinical investigation.
- Centre–State coordination: Coordinates with State Drug Control Organisations for effective enforcement. Central and State regulators share responsibilities for specified products such as vaccines, sera, blood products and IV fluids.
Key Regulatory Challenge
The major gap lies in the post-market use of medicines. Even properly approved drugs can cause wider public-health problems when prescription requirements are bypassed or medicines are used irrationally.
The regulatory approach therefore needs to cover the complete medicine lifecycle:
Pre-market evaluation → Market authorisation → Quality monitoring → Prescription discipline → Post-market surveillance
Way Forward
- Prescription compliance: Improve enforcement of prescription requirements for antibiotics and other restricted medicines.
- Antimicrobial stewardship: Promote evidence-based selection, dosage and duration of antibiotics across healthcare facilities.
- Stronger pharmacovigilance: Improve systematic detection and reporting of adverse drug reactions and emerging safety risks after medicines enter the market.
FAQs
Q1. What is an NSAID?
An NSAID is a non-steroidal anti-inflammatory drug commonly used to reduce pain, inflammation and fever.
Q2. Who heads CDSCO?
The Drugs Controller General of India (DCGI) heads CDSCO.
Q3. Are CDSCO and DCGI the same?
No. CDSCO is the regulatory organisation, while the DCGI heads it and performs specified statutory regulatory functions.
Q4. What is pharmacovigilance?
It is the systematic detection, assessment and prevention of adverse effects or other medicine-related problems.
Q5. Why are antibiotics different from ordinary pain-relief medicines?
Their misuse can select drug-resistant microorganisms, reducing antibiotic effectiveness for the wider population.
