The Karnataka government has reduced the withdrawal timeline for not-of-standard quality (NSQ) medicines from 30 days to just 3 days, aiming to improve patient safety and ensure prompt market recalls. The move places greater accountability on manufacturers and distributors to uphold quality standards.

Key highlights

Faster recall process

• Withdrawal timeline for NSQ drugs cut from 30 days to 3 days.

• Intended to prevent prolonged circulation of substandard medicines in the market.

Recent enforcement actions

• 59 samples declared NSQ after routine inspections and lab testing.

• 29 legal cases filed in July 2025 against companies violating the Drugs and Cosmetics Act & Rules.

• Substandard drugs worth ₹40 lakh recalled in July alone.

Public safety measures

• FDA has warned retailers, wholesalers, and hospital pharmacies against stocking NSQ drugs.

• Public advised not to purchase these medicines; doctors urged to avoid prescribing them.

• Show-cause notices issued to 231 pharmacies for selling antibiotics and sedatives without prescriptions.

Range of affected medicines

• Includes antipyretics, diabetes and hypertension medicines, cardiac drugs, antibiotics, gastrointestinal treatments, vitamins, and injectables.

• Examples: Panoxen, povidone iodine solution, cefixime, sodium chloride injections, rosuvastatin, pantoprazole, telmisartan, adrenaline bitartrate injections, sodium valproate.

Regulatory oversight

• NSQ drugs fail to meet quality standards for purity, strength, dissolution rate, or labelling accuracy.

• Identified drugs are tested at the State Drug Test Lab, with manufacturers issued warnings to rectify manufacturing processes.

• Surveillance to continue under Karnataka’s Health and Family Welfare Department to ensure drug safety and compliance.

Karnataka’s decision to drastically cut recall timelines for NSQ medicines underscores its commitment to consumer safety and strict regulatory enforcement. The faster process aims to protect patients from compromised drugs while holding pharmaceutical companies to higher quality standards.