In a recent investigation by the Central Drugs Standard Control Organization (CDSCO), 17 medicines produced by 12 pharmaceutical industries in Himachal Pradesh have been found to fall short of quality standards. The substandard drugs, which include a range of medicines and injections for treating fungal infections, acidity, seizures, high blood pressure, diabetes, cough, and bleeding control, have raised serious concerns about the quality control measures within the state’s pharmaceutical sector.
The drug alert issued by CDSCO for July revealed that these medicines were manufactured in key pharmaceutical hubs such as Baddi, Tahliwal, Jhadmajri, Solan, Paonta Sahib, Nalagarh and Parwanoo. In addition to the findings from Himachal Pradesh, the alert also flagged 40 other drugs produced in pharmaceutical industries across West Bengal, Uttarakhand, Maharashtra, Bangalore, Chennai, Goa, Gujarat, and Telangana, which similarly failed to meet the required standards.
Among the substandard products, four other medicines tested in various state laboratories were also found to be below quality standards. Notably, despite instructions from CDSCO, Himachal Pradesh has not submitted any drug testing data from its laboratories, further intensifying scrutiny of the state’s pharmaceutical industry. Of the 57 drugs declared substandard in the July alert, 17 were manufactured by companies in Himachal Pradesh. The samples were tested in laboratories located in Kolkata, Guwahati, Hyderabad, Mumbai, and Chandigarh, with the results being made public on Thursday.
State Drug Controller Manish Kapoor has responded to the findings by issuing show-cause notices to all the pharmaceutical companies involved. These companies have also been directed to recall the entire stock of the affected drug batches. Furthermore, Assistant Drug Controllers have been instructed to carry out inspections of industries with repeated failures and to conduct detailed investigations into their manufacturing practices.
List of Substandard Medicines and Injections
As per the information, the investigation found the following medicines to be substandard:
- Itraconazole 100 mg Capsule
- Pantoprazole Tablet
- Carbamazepine Extended-Release Tablet
- Calcium Carbonate, Calcitriol, Methylcobalamin, Folic Acid, and Vitamin B6 Salt Gelatin Capsule
- Azithromycin Tablet
- Ofloxacin and Ornidazole Tablet
- Synetivit Capsule
- Amoxicillin and Potassium Clavulanate Capsule
- Rabeprazole Tablet
- Expectorant Cough Syrup
- Siladar-10 Tablet
- Bioglip 1 Tablet
- Ciprofloxacin Hydrochloride Tablet
In addition, lead contamination was detected in Gentle Daily Care Natural Protein Shampoo, which did not meet the specifications set by the Bureau of Indian Standards (BIS). Two injections were also declared substandard: Compound Sodium Lactate Injection, used for short-term fluid replacement and dehydration, and Tranexamic Acid Injection, used to control bleeding.
The findings from CDSCO’s investigation have put Himachal Pradesh’s pharmaceutical industry under the spotlight, prompting calls for stricter enforcement of quality control standards. This is not the first instance of substandard medicines being found in Himachal Pradesh’s pharmaceutical sector; earlier investigations by CDSCO have also identified similar issues. These repeated concerns underscore the urgent need for improved oversight to ensure the safety and efficacy of medicines produced in the region.
