Medication errors are a silent public-health burden. Examine the regulatory and technological measures needed to strengthen pharmacovigilance and drug traceability in India.

Medication errors cost the world an estimated US$ 42 billion a year [1]. According to WHO, they happen when weak medication systems combine with human factors such as fatigue and staff shortages, at the stages of prescribing, dispensing and administration [1]. They are rarely reported, so the harm stays hidden. India needs regulatory and technological fixes that work together.

Existing gaps

• Pharmacovigilance Programme of India (PvPI): It is coordinated by the Indian Pharmacopoeia Commission and depends on voluntary ADR reporting from monitoring centres in medical colleges [3]. Errors at private chemists and in rural areas mostly go unrecorded.
• Schedule H2 QR code: It stores nine product data items, including batch, manufacturer, licence and expiry [4]. It traces the packet, not the patient, so an error at the chemist's counter leaves no record of who received the medicine.

Manufacturer → QR (batch) → Distributor → Chemist ✗ no buyer record → Patient

Fig: Where the traceability chain breaks

Regulatory measures

• Roll out the expanded Schedule H2 on time: vaccines, NDPS drugs and anti-cancer drugs from 1 July 2027, and antimicrobials from 1 July 2028 [4]. Then add other drugs with a narrow safety margin.
• Make reporting of medication errors mandatory, not just reporting of adverse reactions, with no-blame protection. This matches WHO's view that errors are a systems problem [1].
• Train pharmacists in dispensing safety through the State Pharmacy Councils, building on IPC's existing MoUs with state councils [6]. Enforce double-checks when dispensing high-alert drugs.

Technological measures

• Link the QR scan at the counter to an e-prescription or dispensing record for high-risk drugs. This would complete traceability down to the patient.
• Decision-support alerts in e-prescription software could flag doses above safe limits and catch decimal errors such as tenfold overdoses.
• Use NDMA's SACHET, which is CAP-based, covers all States/UTs and works in 19+ languages [5], to send urgent drug-recall alerts as well as disaster warnings.
• Apply data analytics to PvPI reports to detect safety signals early. Promote public reporting during National Pharmacovigilance Week [3].

Pharmacovigilance and traceability are two halves of one safety system: the first detects harm, the second tells regulators where it came from. With stronger regulation and linked digital records, India can help meet WHO's Medication Without Harm goal of halving severe avoidable medication harm [2]. This would also give practical effect to the right to health under Article 21 and to SDG 3.8 on safe, quality medicines.