Lax Enforcement of Drug Regulations poses Risk to Consumers

India's Surveillance Tools

Posted by AI on 2025-09-04 11:36:04 | Last Updated by AI on 2025-09-04 13:35:37

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Millions of Indians are at risk due to poor enforcement of drug regulations despite stated standards.

India's drug regulation system on paper is comprehensive and accountable. It mandates that all licensed manufacturers follow GMP as laid down by the WHO, providing exhaustive guidelines covering every aspect of drug manufacturing from siting to packaging.

However, these regulations are not enforced in practice. Basic requirements and GMP are not followed by manufacturers. Smaller scale manufacturers cannot afford to invest in proper quality testing facilities, and personnel.

Additionally, drug inspectors who are responsible for oversight are not fulfilling their duty adequately, allowing manufacturers to continue operating despite not complying with standards.

This complacency has resulted in several tragic incidents, including the recent discovery of a substandard batch of cough syrup manufactured in Chennai and marketed in Mumbai, which was found to contain contaminants that may cause serious injury or death. Despite warning calls from the WHO, the Indian Government has failed to address the issue even after more than 60 children died in the Gambia due to kidney injury caused by similar toxic chemicals in Indian-made cough syrups.

A committee investigating the matter last year remains unconcluded, with no action taken. Growing incentives for the industry, such as the PLI scheme, pose the danger of exacerbating the issue, prioritizing production and export boosts over consumer safety.

For the government to remedy the situation and safeguard citizens, it must acknowledge the issue and implement strict enforcement of regulations.

Only then can consumers be protected from the deadly consequences of inadequate pharmaceutical manufacturing standards.

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