71 Drug Samples from Himachal Pradesh Fail Quality Tests in CDSCO Alert

71 Drug Samples from Himachal Pradesh Declared Sub-Standard in CDSCO Alert

The Central Drugs Standard Control Organisation (CDSCO) has issued a critical drug alert, identifying 71 samples manufactured in Himachal Pradesh as not standard quality. This alarming finding highlights significant quality control issues in one of India's key pharmaceutical hubs.

High Percentage of Failures in National Context

In the January alert, CDSCO reported a total of 215 drug samples from across India as sub-standard. The 71 samples from Himachal Pradesh account for a staggering 33.02% of these failures, underscoring a disproportionate contribution to the national problem of drug quality lapses.

Geographic Concentration of Manufacturing Issues

The sub-standard samples were primarily produced in major industrial clusters within Himachal Pradesh:

Baddi-Barotiwala-Nalagarh (BBN) area in Solan district
Kala Amb and Paonta Sahib regions in Sirmaur district

These areas are known for dense pharmaceutical manufacturing activity, raising concerns about systemic oversight.

Wide Range of Affected Medications

The flagged drugs are used to treat various serious health conditions, including:

Acute low blood calcium
Skin infections and severe allergic reactions
Indigestion, heartburn, and peptic ulcers
Respiratory tract infections
High blood pressure

This diversity indicates that quality issues span multiple therapeutic categories, potentially impacting patient safety broadly.

Notable Companies and Products Involved

Specific cough syrups and other medications from several pharmaceutical firms were identified as sub-standard. Companies implicated include:

Ultra Drugs Formulations Pvt Ltd (Baddi-based)
Rumy Pharmaceuticals
Galpha Laboratories Ltd
Innova Captab Ltd
Sidhi Vinayak Industries (Kala Amb-based)
Health Biotech Ltd (Baddi), which produced a local anaesthetic injection

Spurious Drugs Under Investigation

In a more severe category, CDSCO declared three drug samples as spurious:

Ofloxacin and Ornidazole tablets for bacterial and protozoal infections
Azithromycin antibiotic for skin and tissue infections
Trypsin-Chymotrypsin tablets for reducing pain and swelling

Manufacturer names for these spurious drugs have been withheld pending ongoing investigations, as the involved companies deny production, complicating traceability efforts.

Regulatory Actions and Historical Context

The state drugs control administration has announced that notices will be issued to all manufacturers with failed samples. This alert follows a pattern of recurring issues:

In December 2025, 50 out of 164 samples (30.5%) from Himachal were sub-standard.
In November 2025, 49 samples failed CDSCO quality tests.

These consecutive failures suggest persistent quality control challenges in the region.

Himachal Pradesh's Pharmaceutical Significance

Himachal Pradesh is a major player in India's drug production landscape, hosting:

664 pharmaceutical manufacturers
177 cosmetics units
29 medical device companies

Annually, the state contributes approximately 35% of the country's total drug production, making these quality lapses a national concern with implications for healthcare delivery across India.