CDSCO Guideline for Action on Spurious & NSQ Drugs

Amidst the heightened surveillance and enforcement actions initiated by different state licensing authorities (state FDAs) in India on Drugs and Medicine manufacturers, this post highlights the key provisions of the CDSCO guideline on Spurious and Not of Standard Quality (NSQ) Drugs. This guidance was issued following the amendment to the Drugs and Cosmetics Act passed by the Parliament of India on 5 December 2008.

Spurious & Adulterated Drugs

• Spurious drugs: Formulations made to resemble another (often popular) brand to deceive buyers. They may or may not contain the active ingredient, and are manufactured by unlicensed elements or even licensed manufacturers.
• Adulterated drugs: Products contaminated or substituted with harmful adulterants, rendering them injurious to health.

Spurious / NSQ drugs broadly falls under three categories

Category A: Spurious/adulterated drugs (false identity, contamination, harmful adulterants) manufactured by unlicenced manufacturers.

Category B: Grossly sub-standard drugs by licensed manufacturer (serious quality failures like sterility, potency, dissolution, fungal contamination, lower content of active ingredient), defects rising out of gross negligence or non-conformance to GMPs during manufacture

Category C: Drugs with Minor defects like (but not limited to) broken tablets, discolouration, sedimentation, labelling errors, weight / net content variations, manufactured by licensed manufacturers.

Category of Defects

The DCC (Drugs Consultative Committee) guidelines, 1993 define two category of defects for Not of Standard Quality (NSQ) Drugs

Category A defects: Severe assay failures, Sterility failures for sterile products, fungal growth, contamination, toxicity, content uniformity

Category B defects: Spotting, chipping, uneven coating, sedimentation, minor assay deviations, minor discolouration, other minor defects.

The DCC guideline details the Category A and Category B defects across various dosage forms including Tables, Capsules, Injections, Ophthalmic preparations, Liquid Orals, Inhalers, Vaccines, Bulk Drugs.

Enforcement Actions & Penalties

Category A defects will demand Immediate Recall, Show Cause Notice, possible Suspension / Cancellation of license. Category B defects may result in Stoppage of further sales,  Recall, call for Explanation from manufacturer and further administrative actions as necessary.

The Penalties for manufacture of spurious or adulterated drugs range from:

• Minimum 10 years imprisonment, extendable to life.

• Fine: ₹10 lakh or 3× value of confiscated drugs, whichever is higher.

Certain offenses are cognizable and non-bailable. Also several minor offences may be compounded administratively for taking appropriate action. The actions shall be taken in accordance with Section 36AC of the Drugs and Cosmetics Act.

Severity of Enforcement Actions will depend on the seriousness of the defects, offences.

Spurious drugs (unlicensed) trigger top priority actions as per Section 36AC of Drugs & Cosmetics Act including police action and prosecution. Spurious drugs / Grossly substandard drugs by a licensed manufacturer will lead to rigorous investigations and if criminal intent / gross negligence are identified will lead to prosecution. Minor defects trigger administrative actions like Show Cause notice, Suspension of licence, and not generally prosecution. The guideline recommends to use prosecution sparingly for persistent defaulters and serious contraventions, and administrative remedies minor omissions.

Read the complete guidance: Action on samples of drugs declared spurious or notof standard quality (NSQ) under the Drugs and Cosmetics (amendment) Act, 2008. [Document No: CDSCO/ENFORCEMENT/NSQGUIDELINE/001 Version: 00]