New draft guidelines published on 17 September by India's drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), establish new Good Distribution Practices (GDPs) for biological products.
Guidelines on Good Distribution Practices for Biological Products is intended to, "Assist in ensuring the quality and identity of biological products during all aspects of the distribution process," CDSCO writes in the guideline. "These aspects include, but are not limited to procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices."
Protein-based biologic products, even more so than most chemical-based pharmaceutical products, require highly controlled distribution networks to ensure a product stays within acceptable parameters for temperature, sterility, integrity and record-keeping.
To that end, CDSCO's guideline is aimed at protecting the biologics supply chain. "It shall be the responsibility of all parties involved in the distribution of biological products to ensure that the quality of biological products and the integrity of the distribution chain are maintained throughout the distribution process from the site of the manufacturer to the entity responsible for dispensing or providing the product to the patient or his or her agent."
The regulator's intent may be easier said than done, in this case, even if manufacturers attempt to follow it to the best of their ability. Case in point: a massive blackout, allegedly the largest in history, struck the country in August, plunging more than 670 million Indians into darkness on two consecutive days. Without robust backup power supply systems, manufacturers could be stuck with spoiled or deficient biologic products either in their facilities or distribution chains.
Regardless of the difficulties, GDP principles are applicable from the manufacturer to the point of eventual sale, explained CDSCO, with the aim of preventing patients from receiving what regulators referred to as, "Spurious biological products." The guideline states that manufacturers should have written agreements with all agencies involved in the storage, transportation and distribution or products, and such entities should be appropriately authorized and licensed to conduct the work.
Manufacturers will also have to have a well-defined organizational structure in place to define the authority and responsibilities of various entities within their distribution networks, along with designated persons responsible for the quality of products and the maintenance of a quality system. Such responsibilities should be divided so as to not be unmanageable, CDSCO wrote.
Further, such personnel should be adequately trained, including in how to follow standard operating procedures, how to handle products, how to test products, sanitary procedures and how to maintain the integrity of the supply chain.
Other information, such as the maintenance of a facility's quality system, keeping the manufacturing facility in working order and mitigating potential hazards, stock control, transportation, maintenance of the supply chain, documentation, the receipt of complaints and the handling of recalls are also described in detail in the guideline.
The draft guidance does not yet have a date by which it will become effective, but comments are due by 2 October 2012.