Himachal : 37 Drug Samples Fail Quality Tests, 33 Pharmaceutical Units Under Scrutiny

In a significant blow to the pharmaceutical industry in the state, 37 drug samples from 33 pharmaceutical units have failed to meet the quality standards set by the Central Drugs Standard Control Organisation (CDSCO). The troubling findings were part of the monthly alert released by the CDSCO, which flagged 90 drug samples from across the country, with the state being responsible for a substantial portion.

Range of Ailments Affected by Substandard Drugs

The failed samples include a variety of medications used to treat common ailments such as bacterial infections, epilepsy, vitamin deficiencies, fungal infections, asthma, hypertension, and post-operative swelling. Other drugs were intended to manage conditions like bronchitis, pain relief, cholesterol reduction, and gastroesophageal reflux disease (GERD).

Despite the wide range of therapeutic uses, the reported issues in these drug samples point to a serious quality control failure in the manufacturing process, with many of the drugs failing key tests for uniformity, efficacy, and sterility.

Manufacturing Defects: A Serious Breach of Safety Standards

The CDSCO report highlighted several serious issues with the affected drug samples. Common defects include problems with the uniformity of weight and assay, misbranding, discoloration, and the presence of particulate matter in eye drops and injections. These defects are considered grave violations by the regulatory body and raise significant concerns about the safety and efficacy of the drugs in question.

Particularly concerning are the issues with injectable drugs, which are typically subject to stricter quality control measures due to their direct administration into the body. Among the eight injectable drugs flagged by the CDSCO, several critical issues were identified:

• Prochlorperazine Mesylate Injection, used to treat nausea and vomiting, failed the pH test as per the Indian Pharmacopeia.
• Ambilip Injection, used for treating certain infections, was found to contain bacterial endotoxins and lacked an assay for the active ingredient, amphotericin B.
• Betamethasone Sodium Phosphate and Enroxacin Injections, used for treating inflammation and respiratory infections respectively, were found to have particulate matter.
• Acyclotech Injection, a drug for viral infections, failed the assay test, affecting its potency.
• Nataprime Eye Drops, found to have sterility issues, raised serious doubts about its safety for use in treating eye conditions.

State’s Response: Immediate Action to Remove Defective Products

In response to the findings, State Drugs Controller Manish Kapoor assured that all batches of the flagged drugs would be immediately withdrawn from the market. Notices will be issued to the companies responsible for the substandard products, and field staff will conduct thorough investigations to determine the root causes of the manufacturing failures.

Kapoor emphasized that the state authorities were taking the matter seriously and would ensure accountability for any lapses in the quality control process. The swift action is aimed at protecting public health and preventing any further distribution of these defective drugs.

Key Drugs Affected by the Alert

Several well-known drugs have been flagged in the alert, including:

• Cefem-200 Tablet (used for bacterial infections)
• Cefpodoxime Proxetil Dispersible Tablet (for treating respiratory infections)
• Divalproex Sodium SR Tablet (for managing epilepsy)
• Vitamin B Complex Tablets (used to treat vitamin deficiencies)
• Itraconazole Capsules (for fungal infections)
• Cefixime Dispersible Tablets (for bacterial infections)
• Orsemide Tablets (for managing edema)
• Cough DM Syrup (for treating cough and respiratory issues)
• Montelukast Tablets (for asthma management)
• Ciprofloxacin Hydrochloride Tablets (an antibiotic for infections)
• Tyrpsin Chymotrypsin Tablets (for inflammation)
• Rozutin 10 Tablet (used for cholesterol reduction)
• Rabalkem Capsules (for treating GERD)

A Wake-Up Call for the Pharmaceutical Industry

The latest CDSCO alert serves as a stark reminder of the importance of stringent quality control measures within the pharmaceutical sector. The failure of so many drug samples from a range of manufacturers underscores the need for more robust oversight and adherence to industry standards.

As the state authorities work swiftly to remove the defective products from the market, the incident highlights the ongoing challenges in ensuring the safety and efficacy of drugs in the country. Consumers, healthcare professionals, and pharmaceutical companies alike must remain vigilant and committed to maintaining high-quality standards in the production and distribution of medicines.