Govt Proposes Immediate License Suspension For Substandard Drug Manufacturing

New Delhi, Jun 26 (KNN) The Ministry of Health is considering stringent regulatory measures that would mandate the immediate suspension of product licenses for pharmaceutical companies found manufacturing substandard drugs.

The proposed action aims to strengthen quality control mechanisms and protect public health interests across the country, according to a report by ET.

According to government officials, the ministry plans to issue a notification requiring automatic suspension of licenses for companies whose products are classified as ‘not of standard quality’ by government testing laboratories.

The measure is currently under discussion with state authorities as part of broader efforts to ensure pharmaceutical manufacturing standards.

The Central Drugs Standard Control Organisation has been engaging with pharmaceutical industry representatives who have raised concerns about the proposed regulations.

The organisation's technical advisory board on drugs has already endorsed swift action against manufacturers producing substandard medications.

Meeting minutes from the technical advisory board indicate that immediate license suspension should occur once a drug is declared substandard, unless manufacturers provide satisfactory corrective and preventive action plans.

The board recommended appropriate amendments to existing drug rules, with license reinstatement contingent upon completion of root cause analysis and implementation of corrective measures.

A government official, speaking on condition of anonymity, confirmed that the health ministry and regulatory body are soliciting input from states and pharmaceutical organisations before finalising the notification process.

Industry groups have submitted formal objections to the proposed measures.

The Federation of Pharma Entrepreneurs characterised substandard quality issues as a global phenomenon often resulting from technical problems rather than deliberate misconduct.

The organisation has requested comprehensive impact analysis given the regulatory significance of the proposed changes.

Pharmaceutical representatives have highlighted operational challenges within government testing laboratories, suggesting that quality investigations should include review of laboratory records and compliance with good laboratory practices by drug inspectors.

Industry sources noted instances where products initially declared substandard by government laboratories were subsequently classified as meeting quality standards by the appellate laboratory in Kolkata.

(KNN Bureau)