The Central Drugs Standard Control Organization (CDSCO) has flagged 196 drug samples as Not of Standard Quality (NSQ) and one sample as spurious in its latest monthly drug alert. The quality surveillance initiative is part of the government’s effort to monitor and eliminate substandard and counterfeit medicines from circulation.

Key highlights

Spurious steroid sample detected in Bihar

• A nandrolone decanoate injection sold under the name Deca-Durabolin was declared spurious.

• The product was allegedly manufactured by an unauthorized entity using a brand name owned by another company.

• The flagged sample failed tests for identification and assay of nandrolone decanoate.

• The brand Deca-Durabolin 50 mg is currently marketed by Zydus Healthcare, acquired from MSD in 2016.

Breakdown of NSQ findings

• 60 NSQ samples were identified by central drug laboratories, including:

  1. Nimesulide and Paracetamol tablets (Pro-Pharma Care)

  2. Cefpodoxime Proxetil tablets (Sunvij Drugs)

  3. Ciprofloxacin tablets (Cadila Pharmaceuticals)

• 136 NSQ samples were identified by state labs, including:

  1. Glimepiride + Metformin tablets (Surge Pharmaceuticals)

  2. Albendazole tablets (Samkem)

  3. Oxfendazole + Ivermectin bolus (Argon Remedies)

Definition and legal framework

• Drugs are declared NSQ under Section 16(1)(a) and spurious under Section 17-B of the Drugs and Cosmetics Act, 1940.

• A drug is spurious if it is deliberately mislabeled or designed to resemble another product to deceive consumers.

Ministry clarification on NSQ findings

• The Union Health Ministry clarified that failures apply only to the specific tested batch and do not imply a blanket issue with the manufacturer’s other batches or products.

• Routine monthly surveillance is conducted in collaboration with state regulators to ensure rapid detection and removal of such medicines from the market.

The CDSCO’s latest drug alert reinforces the importance of continuous pharmacovigilance in India. With nearly 200 samples failing quality checks and a high-profile spurious case under investigation, the regulatory machinery is on high alert to protect public health and uphold medicine quality standards.