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CDSCO Issues Fresh Draft GDP Guidelines for Pharma Products

Written by : Aishwarya Sarthe

April 15, 2024

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The guideline documents align with WHO standards to ensure quality and safety of pharmaceutical products.

In a move aimed at bolstering the quality and safety of pharmaceutical products circulating in the market, the Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on Good Distribution Practices (GDP) for pharmaceutical products. 

This release follows the framework outlined in the WHO Technical Report Series (TRS) on Good Storage and Distribution Practices, aiming to curb the infiltration of spurious, adulterated, misbranded, and Not of Standard Quality (NSQ) products into the healthcare system.

Per the latest release, the guidelines delineate stringent procedures spanning transportation, shipping, labeling, dispatch, and receipt of pharmaceutical products. 

Moreover, it elucidates the framework for filing complaints, executing recalls and returns, and addressing instances involving spurious, misbranded, adulterated, and NSQ pharmaceutical products.

Emphasis on Self-Inspection

Emphasizing the collective responsibility in upholding pharmaceutical standards, the regulatory authority underscores the necessity for self-inspections within the quality assurance framework. 

"It is imperative that stakeholders incorporate self-inspections within their quality systems. These inspections serve as a crucial mechanism to identify deviations and implement corrective measures proactively,"  a CDSCO representative stated.

The draft guideline also outlines the roles and responsibilities of various stakeholders across the pharmaceutical supply chain, accentuating the shared accountability in ensuring the authenticity and safety of medical products. 

Additionally, the guidelines are also applicable to entities involved in the trade and distribution of pharmaceuticals, encompassing manufacturers, wholesalers, suppliers, logistics providers, and healthcare workers.

Quality Assurance & Compliance

Underlining the regulatory framework established by the Drugs & Cosmetics Act 1940 and Drugs & Cosmetic Rules 1945, the guidelines underscore the imperative for pharmaceutical distributors to adhere to stringent quality standards. 

This includes establishing a documented quality system, appointing a responsible person for each distribution site, and adhering to authorized procedures for product distribution.

Furthermore, the guidelines stress the importance of maintaining a comprehensively designed quality system incorporating Good Storage Practices (GSP) and GDP principles. 

It also mandates the implementation of quality risk management protocols, regular self-inspections, and robust mechanisms for managing returns, complaints, and recalls.

Transportation & Storage Protocols

The latest release also addresses the criticality of transportation and storage conditions. The guidelines upheld the necessity for maintaining prescribed storage conditions per national regulations. 

Temperature mapping storage areas and implementing controls to mitigate risks associated with transportation deviations were also addressed in the latest pharma guidelines.

In addition, the guidelines highlight the responsibility of distributors to ensure the suitability and integrity of vehicles and equipment used for pharmaceutical distribution. 

"The onus lies on distributors to ensure that vehicles and equipment adhere to prescribed standards to prevent any compromise in product quality," remarked a spokesperson from CDSCO.

With a focus on collaborative efforts and stringent regulatory oversight, the guidelines aim to mitigate the risks of infiltrating substandard pharmaceutical products into the market, safeguarding public health, and promoting quality healthcare delivery.


About Chime India

The College of Healthcare Information Management Executives (CHIME) is an executive organization dedicated to serving senior digital health leaders. CHIME includes more than 5,000 members in 56 countries and two US territories and partners with over 150 healthcare IT businesses and professional services firms. CHIME enables its members and business partners to collaborate, exchange ideas, develop professionally and advocate the effective use of information management to improve the health and care throughout the communities they serve. CHIME's members are chief information officers (CIOs), chief medical information officers (CMIOs), chief nursing information officers (CNIOs), chief innovation officers (CIOs), chief digital officers (CDOs), and other senior healthcare leaders. The CHIME India Chapter became the first international chapter outside North America in 2016 and is now a community of over 70+ members in India. For more information, please visit www.chimecentral.org

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