Tue Aug 26 07:35:17 UTC 2025: Here’s a summarized version of the text and a rewrite as a news article:

**Summary:**

A recent study highlights serious shortcomings in India’s drug regulation system, despite the country being a major global supplier of generic drugs. The system suffers from fragmented policies, inadequate enforcement, short-staffing, and outdated practices. Key problems include the prevalence of “branded generics” that offer no cost advantage, ineffective prescription policies, lack of public education, and inspection processes that are often predictable and thus ineffective. These issues are eroding trust in Indian-made drugs and threaten India’s position in the global pharmaceutical market.

**News Article:**

**India’s Pharmaceutical Success Faces Scrutiny: Cracks Appear in Drug Regulation System**

**NEW DELHI – August 26, 2025** – India’s booming pharmaceutical industry, a global powerhouse supplying one in five generic drugs worldwide, faces growing concerns over its regulatory framework, according to a recent study by the Indian School of Business (ISB). The report reveals significant shortcomings in India’s drug regulation, threatening the country’s reputation as a reliable pharmaceutical supplier.

The ISB study, conducted by Parshuram Hotkar and Amanjeet Singh examined India’s pharmaceutical regulatory framework from 2005-2022, exposes a system hampered by piecemeal policy changes, introduced mainly through gazette notifications rather than through proper legislative debate, weak enforcement, and a lack of comprehensive oversight. Key safeguards, such as good manufacturing practices and post-marketing surveillance, were introduced relatively recently, leaving a significant period without critical regulatory oversight.

One major issue is the dominance of “branded generics” – drugs with brand names but without patent protection – which account for 87% of the Indian market. These drugs offer no cost advantage over true generics, yet command higher prices, creating a market imbalance.

The government’s attempt to promote generic prescribing by doctors has been largely ineffective, shifting power to pharmacists who are often incentivized to sell higher-priced alternatives. The report also criticizes the lack of public education on drug safety, leaving consumers vulnerable to substandard or fake medicines.

The study also highlights the need for smarter enforcement, with surprise inspections being more effective than pre-announced ones.

The findings have raised alarms given the growing importance of India’s pharmaceutical sector, which is valued at $50 billion and projected to reach $130 billion by 2030. The country supplies a substantial portion of America’s generic drugs and half the world’s vaccines.

“The existing policies and regulations can be effective in improving the quality of drugs,” the study concludes. “However, authorities remain focused largely on control of illicit and fake drugs while adequate attention is not paid to rules and regulations being ignored or bypassed.”
The study suggests India must address these gaps to maintain its position as a trusted supplier of pharmaceutical products and rebuild public trust in the quality of Indian-made drugs.

Read More