Understanding India's Drug Regulation: FAQs

India’s drug regulation and the Need for modernisation

FAQs

1. What caused the recent deaths linked to cough syrups in India?

The tragic deaths reported in Madhya Pradesh and Rajasthan were caused by contamination of cough syrups with diethylene glycol (DEG) — a toxic chemical known to cause kidney failure. Such incidents occur when industrial-grade ingredients are used instead of pharmaceutical-grade materials, often due to lapses in quality control and regulatory oversight.

2. Why do substandard drugs continue to circulate despite strict laws?

India’s drug regulatory system is highly fragmented. While the Central Drugs Standard Control Organisation (CDSCO) manages approvals and central policy, state drug authorities are responsible for on-ground inspections and enforcement. Differences in state-level capacity, staffing, and infrastructure lead to uneven enforcement and allow substandard drugs to enter the market.

3. What proportion of Indian drugs fail to meet quality standards?

Official surveys indicate that around 3% of medicines sold in India are substandard. However, the actual number may be higher, as many lapses go undetected or unreported until a major health crisis draws public attention.

4. How does India’s pharmaceutical industry perform globally?

India produces nearly 20% of the world’s medicines and is a leading supplier of generic drugs worldwide. Despite this success, only about 1,300 of India’s 10,500 drug manufacturing units comply with the World Health Organization’s Good Manufacturing Practices (GMP). This gap highlights the urgent need for regulatory upgrades and better quality monitoring.

5. What reforms does the New Drugs, Medical Devices and Cosmetics Bill, 2023 propose?

The New Drugs, Medical Devices and Cosmetics Bill, 2023 aims to replace the outdated Drugs and Cosmetics Act, 1940. It introduces risk-based classification of drugs, centralised licensing for high-risk products, online approval systems, enhanced pharmacovigilance networks, and stricter penalties for violations. The Bill seeks to balance industry innovation with public health and patient safety.

6. Why is the new Bill important for India’s global reputation?

India’s position as the “Pharmacy of the World” depends on maintaining consistent safety and quality standards. Swift implementation of the new Bill will reinforce global confidence in Indian medicines, enhance export credibility, and prevent future regulatory failures that can harm both public trust and international trade.

7. How can India strengthen drug safety in the future?

India can improve drug safety by ensuring uniform GMP enforcement across all states, strengthening testing laboratories and post-market surveillance, empowering the CDSCO with greater centralised authority, and establishing strict accountability mechanisms for manufacturers and regulators alike. A strong, transparent, and modernised system will ensure safe, effective, and globally trusted medicines for all.