**Policy Summary: Punitive Measures Against Pharmaceutical Companies Producing Not of Standard Quality (NSQ) Drugs**
This document summarizes the Indian government's policy regarding punitive measures against pharmaceutical companies found to be producing Not of Standard Quality (NSQ) drugs. The policy is articulated in response to Lok Sabha Unstarred Question No. 2191, answered on August 1, 2025, by the Minister of State in the Ministry of Health and Family Welfare.
The core principle of the policy is that the manufacture, sale, or distribution of drugs that are not of standard quality, adulterated, or spurious is prohibited under the Drugs and Cosmetics Act. Violation of this provision constitutes a punishable offense under the Act, subject to prosecution and penalties.
While isolated cases of NSQ drugs are reported periodically, the Central Drugs Standard Control Organization (CDSCO) plays a central role in monitoring and enforcing quality standards. Key actions taken include:
1. **Public Disclosure:** Samples failing quality checks are published on the CDSCO website (www.cdsco.gov.in) under "Drug Alert" as part of monthly drug alerts, ensuring public awareness.
2. **Recall and Distribution Halt:** When a drug sample is declared NSQ by CDSCO's Drug Testing Laboratories, the manufacturing firm is instructed to immediately recall the batch and cease further distribution.
3. **Investigative Actions and Penalties:** Based on the outcome of investigations, licensing authorities undertake actions as per the Drugs and Cosmetics Act and its associated rules. These actions may include:
* Issuing stop production orders.
* Issuing stop testing orders.
* Suspension or cancellation of licenses.
* Issuance of warning letters.
* Issuance of show-cause notices.
Key Entities Referenced
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
Lok Sabha: The lower house of the Parliament of India.
Pharmaceutical companies: Companies that manufacture and sell drugs, subject to quality standards.
NSQ drugs: Drugs that are Not of Standard Quality, failing to meet quality parameters.
Central Drugs Standard Control Organization CDSCO: The national regulatory body for pharmaceuticals and medical devices in India.
SMT.ANUPRIYAPATEL: Minister of State in the Ministry of Health and Family Welfare.
Drugs and Cosmetics Act: The primary legislation in India regulating the manufacture, sale, and distribution of drugs and cosmetics.
Drugs Testing laboratories: Laboratories under CDSCO responsible for testing drug samples.
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.
********