News

Substandard Drugs Tarnish Pharma Industry’s Reputation

Himachal, which contributes to one-third of the country's drug supply, houses 650 pharmaceutical units, yet several companies repeatedly fail to meet quality standards, with monthly cases of subpar samples surfacing.

• By Newsdesk
• New Delhi
• Dec 23, 2024

News

The recurring reports of substandard drugs from pharmaceutical companies in Himachal Pradesh have raised alarms among consumers and highlighted regulatory challenges in the state. Himachal, which contributes to one-third of the country's drug supply, houses 650 pharmaceutical units, yet several companies repeatedly fail to meet quality standards, with monthly cases of subpar samples surfacing.

Health experts warn that such substandard medicines, especially those for chronic and infectious diseases, can worsen health conditions, foster drug resistance, and, in severe cases, result in fatalities. Nationally, substandard medicines account for 3.16% of the total, while Himachal fares better at 1.22% over the past three years, according to a Health Ministry survey.

The State Drugs Control Administration (DCA), in collaboration with Central regulatory authorities, conducted 142 inspections between January 2023 and October 2024, taking action against 116 firms. Measures included suspending the production of specific drugs, initiating legal proceedings, and directing companies to overhaul manufacturing processes. Despite these efforts, habitual offenders persist, frequently appearing in lists of substandard drug manufacturers.

Under revised protocols, companies with consistent quality failures are now subject to monthly or quarterly inspections. To further tighten oversight, the Union Government has mandated that all pharmaceutical firms upgrade their facilities to meet Schedule M of the Drugs and Cosmetics Rules, 1945, aligning them with international standards, including those set by the World Health Organization.

The updated regulations demand enhanced manufacturing processes, including segregated production areas, robust pharmaceutical quality systems, equipment validation, supplier audits, and Good Manufacturing Practices (GMP) compliance. These measures aim to rectify issues like inadequate documentation, poor equipment maintenance, and faulty manufacturing designs, which were flagged during risk-based assessments.

Major pharmaceutical companies with a turnover exceeding ₹250 crore were required to comply with these changes by July 1, 2024, while smaller enterprises have until December 28, 2024. Non-compliance will result in penalties or suspension of licenses.

Although the introduction of stricter standards promises improved drug quality, the alarming number of failed drug samples—such as 11 injections among 25 flagged in September alone—highlights the urgency of these reforms. By addressing systemic flaws and enforcing upgraded manufacturing norms, the industry aims to restore public trust and ensure the production of safe, effective medicines.