SHIMLA, July 20 —The Central Drugs Standard Control Organisation (CDSCO) has declared 59 pharmaceutical products manufactured in Himachal Pradesh as substandard, citing serious lapses in sterility, potency, and formulation. The flagged drugs include a range of critical medications, from common painkillers and antibiotics to essential injections and antiseptics.
Among the list is povidone-iodine solution, a widely used antiseptic for wounds and surgical procedures, which failed quality checks on parameters like pH and assay content. “If the pH is acidic, it can burn the skin. Povidone-iodine must maintain a neutral pH for safe use,” said Dr Sanjay Aggarwal, a surgeon based in Solan. “Deviation in assay content also risks overprescription, which increases side effects.”
The substandard drugs were manufactured by 31 companies located in industrial zones including Baddi, Barotiwala, Nalagarh, Kala Amb, Paonta Sahib, and Solan. A Baddi-based firm repeatedly defaulted in the manufacture of Telmisartan tablets, used to manage hypertension, raising concerns over its compliance with Good Manufacturing Practices (GMP).
The report highlights multiple quality issues including:
- Sterility assay failures
- Non-uniform weight distribution
- Low active pharmaceutical ingredient (API) levels
- Presence of particulate matter in injectable drugs
Several injections failed quality norms, including:
- Methylcobalamin (Vitamin B12 deficiency treatment)
- Tranexamic acid (bleeding disorders)
- Calcium gluconate, Vitamin C, and iron sucrose injections
- Vitamin B12, folic acid, and niacinamide combination injection
Other problematic medications include Mupirocin ointment, used for bacterial skin infections, and a range of oral drugs like:
- Amoxicillin + clavulanate tablets
- Ampicillin + cloxacillin capsules
- Levocetirizine, domperidone, paracetamol, aceclofenac, chlorzoxazone combinations
- Rabeprazole and domperidone capsules
- Ibuprofen IP 400 mg
Six batches of calcium and vitamin D3 tablets from a Nalagarh-based firm failed due to discrepancies in physical description. In total, 14 drug samples from the same company failed to meet prescribed standards — drawing scrutiny of its quality control measures.
“These drugs are commonly prescribed for bacterial infections, acid reflux, fever, hypertension, heart ailments, and nutritional deficiencies,” said a CDSCO official, adding that compromised quality poses serious public health risks.
State Drugs Controller Manish Kapoor assured strict action: “All substandard drug batches will be immediately withdrawn from the market. Our field staff have been instructed to investigate the reasons behind the failures and report any lapses in manufacturing protocols.”
Himachal Pradesh, home to one of India’s largest pharmaceutical clusters, faces renewed pressure to ensure tighter monitoring of drug quality. The CDSCO’s monthly alerts play a critical role in flagging non-compliant medicines, but recurring lapses from several units raise concerns over regulatory enforcement and consumer safety.
