Recurring incidents of diethylene-glycol contamination in Indian-made cough syrups expose systemic gaps in drug quality regulation. Examine the institutional and legal reforms needed to safeguard India's status as the 'Pharmacy of the World'.

Q. Recurring incidents of diethylene-glycol contamination in Indian-made cough syrups expose systemic gaps in drug quality regulation. Examine the institutional and legal reforms needed to safeguard India's status as the 'Pharmacy of the World'. (15 marks, 250-350 words)

India supplies a large share of the world's generic medicines, yet the 2025 deaths of children in Madhya Pradesh and Rajasthan from diethylene glycol (DEG)-contaminated paediatric syrups — flagged in WHO Medical Product Alert N°5/2025 [1] — echo the Gambia and Uzbekistan episodes, showing that the failure is structural, not accidental.

Systemic gaps exposed - Excipient quality: DEG enters when industrial-grade glycerin/propylene glycol replaces pharmaceutical grade — a Good Manufacturing Practice failure, since incoming raw material is not mandatorily tested [2]. - Fragmented federal regulation: drugs fall under Entry 19, List III, splitting licensing between CDSCO and state drug controllers, producing uneven inspection rigour across states [3]. - Last-mile retail leakage: Schedule K, Entry 13 of the Drugs Rules, 1945 let unlicensed village shops sell syrups without a pharmacist's oversight [4].

Institutional reforms needed - Strengthen CDSCO–state coordination through uniform, risk-based inspections; CDSCO's post-2022 risk-based inspection drive of manufacturing units, yielding stop-production orders and licence suspensions, is the model to institutionalise [3]. - Build accredited testing laboratory capacity so every batch of imported excipients is analysed before formulation. - Expand Jan Aushadhi Kendras and licensed rural pharmacies so tighter regulation does not become an access barrier in villages.

Legal reforms needed - The Schedule K amendment (G.S.R. 927(E), December 2025) omitting "Syrup", restricting sale to licensed pharmacies, is a welcome closure of the rural loophole and should be enforced [4]. - Full implementation of revised Schedule M GMP norms, with barcode-based track-and-trace, is essential. - Stricter penalties under the Drugs and Cosmetics Act, 1940 for adulterated drugs must translate into swift prosecution [3].

Regulation must therefore move from reactive recall to preventive assurance across the entire supply chain. Aligning domestic oversight with WHO prequalification standards and Article 47's public health mandate will protect India's children while sustaining its credibility as the pharmacy of the Global South.

(~330 words)

Sources: 1. WHO Medical Product Alert N°5/2025: Substandard (contaminated) oral liquid medicines (13 Oct 2025) — DEG contamination in Coldrif, Respifresh TR, ReLife; child fatalities reported from India 2. WHO, Contaminated medicines affecting children — Q&A — DEG as industrial solvent entering medicines through inadequate manufacturing controls 3. PIB, Steps taken to Prevent Sale of Adulterated Drugs — CDSCO–state risk-based inspections, actions taken, penalties under the Drugs and Cosmetics Act, 1940 4. PIB, Union Ministry of Health and Family Welfare Amends Drugs Rules, 1945; Exemption for Sale of Cough Syrups in Small Villages Withdrawn — omission of "Syrup" from Schedule K Entry 13; sale now only through licensed pharmacies