Regulatory Actions on Indian Pharma Industry and Quality Assurance

Simultaneously, 131 drug testing laboratories faced regulatory actions, with testing activities suspended in 52 instances.

The Health Master

February 19, 2024

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Drug Medicine Pharma manufacturing Factory Industry Unit — Picture: Pixabay

Table of Contents

Last Updated on March 1, 2024 by The Health Master

Regulatory Actions

Regulatory Actions: The Indian pharmaceutical landscape has witnessed a significant upheaval in the past year, with authorities cancelling licenses of 64 pharma companies and shutting down 17 drug testing laboratories.

This rigorous enforcement comes as a response to non-compliance with ‘good manufacturing practices’ (GMP) and procedural lapses.

Let’s delve into the details of this regulatory crackdown and its implications.

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Understanding GMP

GMP as a crucial aspect of quality assurance, ensuring that medicinal products are consistently produced and controlled according to the appropriate quality standards.

GMP covers various facets, including production, quality control, distribution responsibilities, contract manufacturing, and responses to product defects and complaints.

Legal Components Encompassed by GMP

In addition to the technical aspects, there is a legal component to GMP that extends to distribution, contract manufacturing, testing, and addressing product defects and complaints.

This legal framework emphasizes the need for pharmaceutical entities to adhere to stringent standards throughout their operations.

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Investigation and Regulatory Actions

Over the past 12 months, the regulators conducted checks and investigations involving 423 companies, spanning both listed entities and drug testing laboratories.

Operations were halted at 101 pharma companies, 52 licenses were suspended, and show-cause notices were issued to 281 companies.

Simultaneously, 131 drug testing laboratories faced regulatory actions, with testing activities suspended in 52 instances.

The ongoing nature of the review process ensures a comprehensive evaluation of pharma companies and drug testing laboratories.

Renewal and Re-issuance of Licenses

Notably, none of the cancelled licenses has been renewed or re-issued.

The regulatory authorities maintain a stringent stance on compliance with GMP, and the review of operations remains an ongoing process.

Compliance with GMP

Corrective actions were taken in some cases after the issuance of notices, highlighting the regulatory authorities’ commitment to encouraging compliance.

However, suspension and cancellation occurred in situations where there was a repeated failure to adhere to GMP.

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Overview of Pharma Industry in India

India boasts around 10,500 manufacturing units, with approximately 8,500 falling under the MSME category.

Of these, around 2,000 MSMEs, primarily exporters, have obtained WHO GMP certification.

Adherence to GMP has become mandatory for all pharma companies operating in India, emphasizing the industry’s commitment to quality.

Crackdown Against Spurious Drug-Makers

The regulatory crackdown gained momentum following reports of spurious drugs being exported from India. Concerns regarding the quality of cough syrups, prompted stringent measures.

As of December, around 50 cough syrup manufacturers failed to meet quality standards, leading to tightened export norms.

India’s Position in the Global Pharma Market

India stands as the world’s third-largest drug maker by volume, trailing only the US and China.

Pharmaceutical exports are projected to surpass $20 billion in FY24, with cough syrup exports accounting for $15 million annually.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.