Quality shock: 66 drug samples from state declared substandard

A sweeping monthly alert issued by the Central Drugs Standard Control Organisation (CDSCO) has flagged 66 drug samples manufactured by 46 pharmaceutical companies in Himachal Pradesh as ‘not of standard quality (NSQ)’, raising serious concerns over lapses in the state’s sprawling pharma ecosystem. These samples are part of a larger national list of 211 failed drugs, which also includes critical medicines used for cancer, cardiac care, infections, psychiatric treatment and diabetes.

The findings have placed multiple firms from key industrial centres — Baddi, Barotiwala, Nalagarh, Kala Amb, Solan, Paonta Sahib, Una and Kangra — under strict scrutiny. What has particularly alarmed regulators is that several companies registered multiple failures, including one Nalagarh-based unit where seven samples did not meet quality norms, and two firms in Paonta Sahib with an equal number of failed products.

Beyond Himachal, 145 failed samples originated from Gujarat, Haryana, Punjab, Jammu, Andhra Pradesh, Madhya Pradesh, Bengal, Maharashtra and other states, pointing to a broader quality-control challenge in India’s pharmaceutical supply chain.

Of the 211 substandard samples, 63 were declared NSQ by the Central Drugs Laboratory, while 148 failed tests conducted in state drug testing laboratories. The products were found deficient across critical parameters such as assay, dissolution, identification, disintegration, content uniformity, particulate matter, sterility and pH. Many of these defects are considered high-risk and are typically linked to systemic lapses in manufacturing oversight or non-adherence to good manufacturing practices (GMP).

The episode has dealt a blow to Himachal Pradesh’s reputation as Asia’s premier pharma hub, especially given that the state accounts for 31 per cent of all substandard samples in the national alert. Industry insiders warn that such frequent lapses could undermine trust in the state’s manufacturing standards at a time when India is positioning itself as a global pharmacy.

Reacting swiftly, the State Drug Controller Manish Kapoor confirmed that notices have been issued to all offending firms, with directions to immediately withdraw the failed batches from the market. The department has also initiated re-sampling, factory inspections, GMP audits and “risk-based inspections” for repeat offenders to identify systemic failures and enforce corrective actions.

The CDSCO, in coordination with state regulators, continues to intensify market surveillance to protect public health and ensure that medicines reaching patients meet mandatory safety and quality benchmarks.