Shimla, August 23: In a recent investigation conducted by the Central Drugs Standard Control Organisation (CDSCO), 17 medicines produced by 12 pharmaceutical industries in Himachal Pradesh have been found to be below quality standards. The substandard medicines, which include a wide range of medicines and injections for fungal infections, acidity, seizures, hypertension, diabetes, cough and bleeding control, have raised serious concerns about quality control measures in the state’s pharmaceutical sector.
The drug alert issued by the CDSCO for July revealed that these medicines were manufactured in major drug hubs such as Baddi, Tahliwal, Jhadmajri, Solan, Paonta Sahib, Nalagarh and Parwanoo. Apart from the findings from Himachal Pradesh, the alert also flagged 40 other drugs produced in pharmaceutical industries in West Bengal, Uttarakhand, Maharashtra, Bangalore, Chennai, Goa, Gujarat and Telangana, which similarly failed to meet the required standards.
Apart from the substandard products, four other drugs tested in various state laboratories were also found to be below quality standards. Notably, despite CDSCO’s directions, Himachal Pradesh has not submitted any drug testing data from its laboratories, further intensifying the scrutiny of the state’s pharmaceutical industry. Of the 57 drugs declared substandard in the July alert, 17 were manufactured by Himachal Pradesh companies. The samples were tested at laboratories located in Kolkata, Guwahati, Hyderabad, Mumbai and Chandigarh, the results of which were made public on Thursday.
State Drug Controller Manish Kapoor has issued show-cause notices to all the concerned pharmaceutical companies to respond to the findings. These companies have also been directed to recall the entire stock of the affected drug batches. Besides, Assistant Drug Controllers have been directed to inspect industries with repeated failures and conduct a detailed investigation of their manufacturing practices.
List of substandard medicines and injections
According to the information, the following medicines were found substandard in the investigation:
- 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
Further, lead contamination was found 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: the compound sodium lactate injection, used for short-term fluid replacement and dehydration, and tranexamic acid injection, used to control bleeding.
The findings of the CDSCO investigation have put Himachal Pradesh’s pharmaceutical industry in the spotlight, leading to demands for strict enforcement of quality control standards. This is not the first case of substandard drugs being found in Himachal Pradesh’s pharmaceutical sector; similar issues have been identified in earlier investigations by the CDSCO. These repeated concerns underscore the urgent need for better monitoring to ensure the safety and efficacy of drugs produced in the sector.
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