CDSCO Issues Nationwide Alert on Indiscriminate Use of Painkillers and Antibiotics Over Severe Renal Risks and AMR

In a comprehensive regulatory circular, the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services (DGHS), has strongly warned against the indiscriminate and repeated use of non-steroidal anti-inflammatory drugs (NSAIDs/painkillers) and antibiotics.

Issued by the New Drugs Division and signed by Drugs Controller General (India) Dr. Rajeev Singh Raghuvanshi, the circular (dated September 21, 2026) flags grave clinical consequences, notably drug-induced renal impairment, acute kidney injury (AKI), and escalating antimicrobial resistance (AMR). The advisory lays down targeted directives across five key stakeholder tiers: the general public, prescribers, retail/wholesale pharmacists, healthcare institutions, and state drug regulatory authorities.

Key Regulatory Highlights

Statutory Compliance Under Drugs Rules, 1945: CDSCO reiterates that most commonly used NSAIDs are categorized under Schedule H, while frontline antibiotics are classified under Schedule H1. Both schedules legally require a valid prescription from a Registered Medical Practitioner (RMP) prior to dispensing.
Prohibition of Over-the-Counter Dispensing: Chemist shops and retail pharmacists are strictly directed not to facilitate OTC sales or encourage self-medication for Schedule H and H1 medications.
Prescription Audits & Stewardship: Hospitals and clinical establishments are instructed to implement stringent antimicrobial stewardship programs (AMSP) and routine prescription audits to curb unwarranted combination therapies and overuse.

Stakeholder Directives: At a Glance

Stakeholder Group	Core Directives & Clinical Mandates
General Public & Patients	• Avoid self-medicating with painkillers or antibiotics for routine viral ailments, colds, or uncomplicated fevers. • Never share prescribed antibiotics or consume leftover strips from prior illnesses. • Disclose any history of kidney ailments, hypertension, or chronic conditions to healthcare providers before taking NSAIDs. • Seek timely clinical consultation if pain or fever recurs instead of relying on frequent self-dosing.
Doctors & Healthcare Practitioners	• Prescribe NSAIDs at the lowest effective dose for the shortest feasible duration. • Exercise high caution when prescribing NSAIDs to elderly patients, dehydrated individuals, or those with underlying cardiac and renal comorbidities. • Follow established antimicrobial stewardship principles: align antibiotic choice with suspected pathogens, infection severity, and local antibiograms rather than ordering broad-spectrum coverage empirically.
Pharmacists, Retailers & Distributors	• Strictly uphold Schedule H and Schedule H1 dispensing logs and record-keeping mandates. • Verify valid physical/digital prescriptions bearing RMP registration details. • Adhere strictly to mandatory cautionary labeling and warning boxes displayed on drug packaging.
Hospitals & Clinical Establishments	• Institutionalize internal monitoring committees for rational antibiotic and painkiller administration. • Conduct regular prescription reviews and enforce in-house clinical pharmacology oversight.
State Drug Control Authorities	• Intensify field inspections of retail counters to curb OTC dispensing of Schedule H/H1 formulations. • Organize public and professional awareness drives concerning renal toxicities and AMR.

Focus on Patient Safety

The directive reinforces the Central Government’s focus on mitigating avoidable adverse drug reactions (ADRs) and curbing antimicrobial resistance—a major public health concern in the country. CDSCO has called upon all health professionals and state regulators to foster responsible therapeutic practices to safeguard vital organ health and preserve antibiotic efficacy.