On September 25, 2018, the Central Drugs Standard Control Organization (CDSCO) has released the draft guidelines on 'Good Distribution Practices' (GDP) to regulate the quality of pharmaceutical products over entire chain of distribution in the country1.
The idea of GDP was initially deliberated in the 54th Drug Consultative Meeting held on July 07, 2018, and it was recommended to take necessary provisions to impart legal sanctity to the 'GDP Guidelines' as a Schedule to the Drug & Cosmetics Rules, 1945 (the 'Rules') to penalize the offenders2.
According to a recent World Health Organization (WHO) report3, an estimated 01 in 10 medical products circulating in low- and middle-income countries like India, is either substandard or falsified. According to the UN agency, these medicines not only fail to treat or prevent diseases but can also cause serious illnesses or even death. Further, the first-ever national drug survey 2014-164, conducted by the union Ministry of Health and Family Welfare, shows that over 3% of all drugs sold across India are of substandard quality.
The objective of these draft guidelines is to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. These aspects include, but are not limited to procurement, purchase, storage, distribution, transportation, documentation and record-keeping practices. These guidelines are intended to be applicable to all persons and outlets involved in trade and distribution of pharmaceuticals, including the manufacturers of bulk, finished products, wholesalers, as well as others such as suppliers, distributors, Government institutions, international procurement organizations, donor agencies and certifying bodies, logistics providers, traders, transport companies and forwarding agents and their employees as well as health workers. It also covers biological products in general.
Documentation and records
The guidelines lay out various measures to guarantee that medicines entering the distribution chain have proper documentation to permit traceability. Records of expiry dates and batch numbers should be part of the documentation to facilitate product recall. Moreover, procedures for procurement and release shall be in place to ensure that appropriate products are sourced only from approved suppliers and distributed by recognised entities. Inspection, auditing and certification of compliance with a quality system such as the ISO series or national guidelines by external bodies are recommended.
Storage and transportation
The guideline suggests that the storage and transportation of pharmaceutical products should match the storage conditions indicated on the packaging/labelling information. The individuals responsible for the transportation of pharmaceutical products shall be informed about all relevant conditions for storage and transportation and these requirements shall be adhered to throughout the transportation and at any intermediate storage stages.
The entire storage facility should be temperature mapped under representative conditions. Equipment used for monitoring of storage conditions shall also be calibrated at defined intervals. Where special conditions are required during transportation that are different from or limit the given environmental conditions (e.g. temperature and humidity), these shall be provided by the manufacturer on the labels and shall be monitored and recorded. If a deviation has occurred during transportation, it shall be reported to the distributor and recipient of the affected pharmaceutical products.
Recalls and Returns
The guideline envisages there shall be a system of written procedure for the management of recalls of defective pharmaceutical products with a designated person responsible for recalls. The system of recall shall comply with Drugs & Cosmetics Act, 1940 and Rules thereunder.
Recall operations shall be capable of being initiated promptly and at any time. The distributor shall follow the instructions of a recall message, the distribution records shall be readily available to the person(s) responsible for the recall and shall contain sufficient information on distributors and directly supplied customers (with addresses, phone and/or fax numbers inside and outside working hours, batches and quantities delivered). Recalled pharmaceutical products shall be identified and stored separately in a secure area while awaiting a decision on their disposal.
Note – The Draft GDP Guidelines for Pharmaceutical Products is available on CDSCO official website and is open for stakeholder comments/feedback, further for consideration and finalization of said Guidelines.
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