The Union health ministry will now need to bring in Good Storage Practices (GSP) as a dedicated guidance which is the most critical component in pharma supply chain management. There is need for accountability in storage of drugs going by the variation in temperature in the country from Kashmir to Kanyakumari and Jaipur to Imphal, said Dr BR Jagashetty, former national advisor (drugs control) to Union health ministry and former drugs controller of Karnataka.
GSP will play an important role in monitoring product quality. Hence it should deal with not only the temperature control with installation of air-conditioners, but also focus on ensuring adequate ventilation, protection from direct sunlight, roof leakages especially during monsoon, check for damp walls, damaged flooring, windows and doors besides monitoring presence of rodents and insects. Adequate attention should also be paid to storing of products to facilitate the first-to-expire, first-out (FEFO) policy, he said.
There is need to ensure drugs covering vaccines, antibiotics, injectables along with a host of new medications like biosimilars and biologicals require right environment and temperature controlled systems. More often drugs are tested to be substandard because of poor storage conditions at various stages. Further, drugs lose potency during poor transportation processes.
There is also need to ensure right temperature storage of blood and blood products or components which are critical lifesaving products. Poor storage of tablets and capsules results in discoloration, crumbling, odour and stickiness. Specific to medical devices, instances of torn or ripped packaging, missing and broken or bent parts, presence of moisture are common occurrences. Similarly, if liquids are not stored right, discoloration, cloudiness, broken seal of bottle, cracked ampoules and dampness in packaging are reported.
Currently, Schedule P of the Drugs & Cosmetics Act & Rules provides information on how certain drugs must be stored. But now in the current context, this is losing its relevance going by new drugs and medical devices that warrant considerable temperature controlled environment during storage and its transport. Therefore, there is a need for an amendment of Drugs & Cosmetics Act & Rules to include GSP as a separate schedule covering right and required environment, he added.
The key point is to ensure accountability on the part of pharma companies, retail outlets and wholesalers apart from the distribution centres and road cargo logistics to transport. The pharma industry’s efforts to come out with new drugs will be futile if precise storage practices are not put in place, Dr. Jagashetty told Pharmabiz.
GSP can be worked on similar lines like that of the Good Manufacturing Practices, Good Laboratory Practices and Good Distribution Practices. Another fact is that with global regulators issuing good storage norms, India cannot be left behind as every third drug prescribed globally is from India, said Dr. Jagashetty.
There is also a need to install security and surveillance systems to monitor the storage practices maintained. We also see the need to ensure that GSP guidelines include the responsibility of all stakeholders from manufacturers to retailers including clearing and forwarding agents (C&F agents) who are part of the supply chain management, said Dr. Jagashetty.