13/14 December 2023
The Central Drugs Standard Control Organization (CDSCO), India's Authority for Medicinal Product, has published a draft Guideline on Good Distribution Practice (GDP) for biological products. The Indian Guideline follows a number of initiatives from authorities worldwide. The distribution of medicinal products has called the attention of the regulators worldwide.
The handling, storage and distribution of biological products need special attention. The new Draft Guideline defines in 5.3. that "Only authorized persons or entities who hold the appropriate license shall be entitled to import or export biological products." The question of the authorisation of stakeholders in the supply chain is one of the major challenges of GDP. Currently, there is no comprehensive oversight in place but registration and supervision are needed. Subcontracting is very common in the supply chain and pharmaceutical companies might not be aware of potentially additional stakeholders. The Indian GDP Guideline has addressed this issue as well.
The chapters of the proposed Guideline cover similar aspects like the Guideline of WHO, EMA and others:
The concrete requirements are less detailed than in the new EMA Draft Guideline on GDP for example. Chapter 7 of the CDSCO Guideline defines that all personnel involved in distribution activities shall be trained. There is a requirement to have a responsible person for each distribution site but the requirements are less detailed as foreseen in the EMA GDP Draft Guideline. It is certainly a step forward that written and approved procedures as well as record keeping is demanded in the document. Reference has been made to Good Storage Practices (GSP), however there is no link to the concrete GSP Guideline. The requirements in Chapter 9 on premises, warehousing and storage are very vague. Chapter 10 defines some more details when it comes to temperature environment and stock control. Temperature mapping and alarm systems (should warn when there are deviations from pre-defined storage conditions) are required.
In India blackouts occur quite often. This can be a critical safety issue for biological products. Therefore 10.8. defines that "storage areas shall be equipped with backup power source or have alternate storage available in the event of power failure."
When it comes to critical activities the Guideline is still too vague. E.g. it is defined that "dedicated vehicles and equipment shall be used" but the use of the words "where possible" sets limits. According to Chapter 20, contract activities need to be controlled. However, the Guideline lacks the detailed requirements.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Source: Draft Guideline on Good Distribution Practice (GDP) for biological products published by Central Drugs Standard Control Organization (CDSCO)