Tamil Nadu Cracks Down on Pharmaceutical Violations

Tamil Nadu has identified and initiated prosecution against 16 manufacturers of Not-of-Standard-Quality (NSQ) drugs

April 19, 2024

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FDA State Food and Drugs Administration — FDA

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Last Updated on April 26, 2024 by The Health Master

Tamil Nadu

The Tamil Nadu government is taking a firm stance against violations in the pharmaceutical trade, prioritizing public health and safety.

Recent actions by the Department of Drugs Control (TN-DDC) have resulted in regulatory measures against 88 pharmaceutical traders, including wholesalers and retailers, for non-compliance with the Drugs and Cosmetics Act, 1940 and Rules 1945.

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Focus Areas and Stringent Action

Combating Substandard Drugs:

While Tamil Nadu hasn’t reported instances of spurious drugs (counterfeit with no active ingredients), the department has identified and initiated prosecution against 16 manufacturers of Not-of-Standard-Quality (NSQ) drugs.

These drugs may be ineffective or pose health risks due to deviations from prescribed quality standards.

Ensuring Qualified Supervision:

Patient safety is paramount, and the TN-DDC is taking action to ensure qualified supervision in pharmacies.

Sanction orders for prosecution have been issued against 13 medical stores for selling medicines without a registered pharmacist on duty.

Regular inspections (weekly) are planned to enforce this regulation.

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Prescription Drug Compliance:

Dispensing prescription drugs without a valid prescription from a registered medical practitioner (RMP) is a serious offense.

The department has issued 38 sanction orders against medical stores for non-maintenance of prescription registers and the sale of Schedule H & H1 drugs (restricted medications) without RMP prescriptions.

Tackling Other Violations:

The TN-DDC has identified and addressed other violations of the Drugs and Cosmetics Act and Rules. These include:

Expired Drugs:

Thankfully, no instances of expired drugs being sold were found in any wholesale or retail medical stores.

General Non-Compliance:

However, 46 sanction orders were issued against various traders for violating provisions of the act and the rules.

Additionally, one sanction order was issued under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMRO Act).

Beyond Sanction Orders: Cancellations and Suspensions

The TN-DDC has taken strong measures to deter future violations. In the period between January 1st and April 15th, 2024:

License Cancellations: The department permanently cancelled the sale licenses of seven establishments.
License Suspensions: Licenses were suspended for 81 businesses, impacting both retail (62) and wholesale (19) operations.

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