GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2191
TOBE ANSWERED ON01ST AUGUST,2025
PUNITIVE MEASURE AGAINSTPHARMACEUTICALCOMPANIES PRODUCING
NSQ DRUGS
2191.THIRU D M KATHIRANAND:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether any strict punitive measure is being proposed by the Government as a...
GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 2191 TOBE ANSWERED ON01ST AUGUST,2025 PUNITIVE MEASURE AGAINSTPHARMACEUTICALCOMPANIES PRODUCING NSQ DRUGS
2191.THIRU D M KATHIRANAND:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether any strict punitive measure is being proposed by the Government as a warning against Pharmaceutical companieswhose productsfail qualityparameters and are declared as substandard andif so, the detailsthereof;
(b) whether the Government is aware of the mushrooming of Pharma companies producing ‘Not of StandardQuality’ (NSQ) drugs andif so, the detailsthereof; and
(c) whether the Central Drugs Standard Control Organization (CDSCO) has announced immediate suspension of product licences of companies found producing ‘Not of Standard Quality’ (NSQ) drugs byGovernment laboratoriesandif so, the detailsthereof? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT.ANUPRIYAPATEL)
(a)to(c): As per the provisions of the Drugs and Cosmetics Act, no person shall manufacture, sell, or distribute any drug that is not of standard quality, adulterated, or spurious. Any contravention of this provision constitutes a punishable offence under the said Act andThe Act prescribes prosecution andpenaltyfor the same.
Isolated cases of Not of StandardQuality (NSQ) drugs are reportedfrom time totime.
The samples failing in quality check are uploaded on the website of Central Drugs Standard Control Organization (CDSCO) under the heading of Drug Alert (www.cdsco.gov.in), as part of the monthlydrug alertstomake it availablepublicly.
In case of drug samples declared as NSQ by the Drugs Testing laboratories under CDSCO, the respective manufacturing firms are asked for immediate recall and stop further distribution of the not of standard quality drugs inthe market. Further, based on investigation outcome, actions are taken by the licensing authorities concerned under the provisions of Drugs & Cosmetics Act & Rulesmade thereunder such asstop productionorders, stop testing orders, license suspensions/cancellations, warning lettersandshowcause notices.
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