The Central Drugs Control Standards Organization (CDSCO) has invited public comments on draft Guidelines on Good Distribution Practices for Pharmaceutical Products till 9th September, 2024. Comments / suggestions may be sent via e-mail to the dci@nic.in and qmscdsco@gmail.com.
Key Highlights:
1. Objective:
Ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. These aspects include, but are not limited to procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices.
2. Scope:
Applicable to all persons and outlets involved in any aspect of storage and distribution of pharmaceutical products from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to a patient or his or her agent. This includes all parties involved in trade and distribution of pharmaceutical, including the manufacturers of bulk, finished products, wholesalers, as well as others such as suppliers, distributors, Government institutions, international procurement organization, donor agencies and certifying bodies, logistics providers, traders, transport companies and forwarding agents and their employees as well as health workers.
It further covers biological products in general. However, for specific purpose, guidelines on Good Distribution Practices for Biological Products as published in CDSCO website shall be referred.
3. General Principles:
All parties involved, from manufacturers to distributors and regulators, are required to ensure adherence to Good Distribution Practices (GDP) for both forward and reverse movement of pharmaceutical products, including returns and donations. Collaboration among government bodies, custom agencies, law enforcement, regulatory authorities, and other stakeholders is crucial to prevent spurious products, uphold product safety, and preserve the integrity of the distribution chain.
4. Regulation of the Distribution of Pharmaceutical products:
Distributors or their agents must source pharmaceutical products from authorized suppliers and can only provide these products to other authorized entities. If a distributor outsources any of its activities, the subcontracted entity must also be properly authorized and maintain the same standards as the original distributor.
5. Organization and Management:
An effective organizational structure for each entity in the distribution chain must be established through an organizational chart that outlines the responsibilities, authority, and relationships of all personnel. Written job descriptions should clearly define individual duties and responsibilities, and employees must be properly informed and trained. A designated person must be responsible for implementing and maintaining the quality system, with managerial and technical personnel having the necessary authority and resources to uphold quality standards and address any deviations. It must also be ensured that no individual’s responsibilities are overly burdensome to avoid compromising product quality, and safeguards should be in place to prevent any external pressures or conflicts of interest from affecting the quality of service and product integrity.
6. Quality System:
Entities involved in the storage and distribution of pharmaceutical products must have a well-designed, documented, and properly implemented quality system that adheres to Good Storage Practices (GSP) and Good Distribution Practices (GDP), incorporates quality risk management, and includes management reviews. Senior management is responsible for ensuring this system is effective and maintained. The quality system must cover various aspects, including adherence to GSP and GDP, detailed operational procedures, clear job responsibilities, risk identification and control, outsourced activity management, self-inspection and quality audits, quality risk management, and processes for handling returns, complaints, recalls, changes, deviations, and corrective actions. A written quality policy or manual must outline overall quality intentions, with risk assessments based on scientific knowledge aimed at protecting patients. Controls for managing risks should be developed, implemented, and periodically reviewed for effectiveness.
7. Premises Warehousing and Storage:
Premises for pharmaceutical operations must be well-located, designed, constructed, and maintained to facilitate efficient receiving, storage, picking, packing, and dispatch. Storage areas need to be secure, structurally sound, and of adequate size, with sufficient lighting for safe operations. They should be clean, dry, and kept within acceptable temperature ranges, with products stored off the floor and properly spaced. Areas for quarantined, rejected, expired, recalled, or suspected spurious products must be clearly identified and segregated to prevent misuse. Systems should ensure first expiry/first out (FEFO) practices, manage broken or damaged stock separately, and include dedicated, secure spaces for hazardous materials like radioactive substances and narcotics. Regular cleaning and separation of receiving and dispatch bays are also required to avoid product mix-ups and protect items from weather conditions.
8. Temperature, Environment and Storage Control:
Pharmaceutical products must be stored according to manufacturer recommendations to ensure quality, with facilities providing appropriate conditions and records maintained for critical storage aspects such as temperature. Temperature monitoring equipment must be regularly checked and calibrated, with records kept for at least the product’s shelf life plus one year. Stock levels should be recorded and updated continuously, with periodic reconciliations and investigations of discrepancies to prevent and address issues. Damaged containers should be reported and assessed to ensure product quality, and stock nearing expiry must be managed appropriately.
9. Documentation:
Documentation involves maintaining all written procedures, instructions, contracts, records, and data—whether paper or electronic—in an organized, accessible, and secure manner. This includes detailed records of pharmaceutical product distribution, such as receipts and issues, and must include specific details like date, product name, batch number, quantity, and supplier information. Procedures must be established for the creation, review, approval, and management of these documents, with records being created and maintained in various forms, including invoices and delivery slips. Additionally, safeguards must be in place for temperature control, security, destruction of unusable stocks, and retention of records, which should be protected from unauthorized changes or loss. Backup systems are required to prevent data loss for electronic records.
10. Recalls and Returns:
A written procedure for managing recalls of defective pharmaceutical products must be established, with a designated person responsible for overseeing recalls. This procedure should be reviewed and updated annually and must comply with the Drugs & Cosmetics Act, relevant rules, and CDSCO guidelines. During a recall, the original manufacturer or marketing authorization holder should be informed and consulted where possible, and national or state regulatory authorities must be notified. Recall operations should be swift and capable of being initiated at any time. Recalled products must be identified, stored securely, and clearly labelled during transit, maintaining their storage conditions. All customers and authorities in all distribution regions must be informed of the recall. Returned products should be quarantined, assessed for quality, and either destroyed or reissued according to international and local regulations, with detailed records kept of all actions taken
A copy of the draft is linked below for your ease of reference.
Source: Central Drugs Control Standards Organization
