Hridkamal Roy, Editor, India Pharma Outlook
The Central Drugs Standard Control Organization (CDSCO) has recently released a document on Good Distribution Practices (GDP) that concerns all pharmaceutical products being sold in India. The guidelines have been formed in line with the WHO Technical Report Series (TRS) on Good Storage and Distribution Practices that aims to avoid the distribution and circulation of spurious, adulterated, misbranded and Not of Standard Quality (NSQ) products. Research conducted by India Pharma Outlook revealed that in a few states, the state governments are involved in validating manufacturers without any proper approval which is also a reason for the circulation of spurious and adulterated drugs in the market. Introduction of the GDP guidelines was first proposed by the Drugs Consultative Committee (DCC) last month and it also suggested that the guidelines be made part of the Drugs and Cosmetics Rules, 1945 in order to ensure even implementation all across the supply chain process.
“The objective of these 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, purchasing, storage, distribution, transportation, documentation and record-keeping practices”, as has been mentioned in the document.
There are various supply chain deficiencies that the GDP guidelines aim to solve which relate to transportation, shipping, labeling, dispatch and receipt of the pharmaceutical products.
One of the biggest challenges faced by the Indian pharmaceutical sector currently is related to logistics and transportation. There is a deficit in information delivery regarding the exact availability of raw materials in storage which is constantly delaying the production process. Warehouse management is another important aspect that must be considered in this regard as it is one of the primary factors for pharmaceutical production.
According to the recent GDP guidelines rolled out by CDSCO, all pharmaceutical products need to be transported according to the storage conditions indicated on the packaging and on the label. The personnel who are responsible for transportation of pharmaceutical products need to have information about all necessary conditions regarding storage and transportation. These requirements shall be adhered throughout transportation and at any intermediate storage stages.
The pharmaceutical industry in India faces several challenges in temperature management, environmental regulations, and stock control, which can significantly impact the quality and efficacy of medicines.
According to the GDP guidelines, records shall be maintained for storage conditions if they are critical for the maintenance on the basis of characteristics of the pharmaceutical products. Temperature monitoring data must always be available for review and there needs to be defined intervals for temperature checks. Monitoring equipment must also go through checks at regular intervals and the results must be registered and all the data gathered must be stored for more than a year.
The areas for storage need to be temperature mapped under suitable conditions. With temperature mapping uniformity of the temperature across the storage facility can be determined which is why it is suggested that temperature monitors be located in areas which are most likely to show fluctuations. It is also important that the equipment that fulfills the purpose of monitoring storage conditions also be calibrated at defined intervals.
Stock level records for pharmaceutical products must always be maintained in-store in either digital or traditional notes format. These records need to be updated after every operation (e.g. entries, issues, losses, adjustments) and all these records shall be kept for a suitable period of time and readily available.
Dispatch and receipt deficiencies in the Indian pharmaceutical sector can have significant implications for the quality, safety, and availability of medicines. The challenges are faced on the grounds of transportation infrastructure, packaging and handling practices, cold chain facilities, inventory management and others.
This is the reason why the guidelines by CDSCO aim to ensure that selling or distribution of pharmaceutical products shall be done to persons or entities that are authorized to acquire such products in accordance with the applicable national, state and international legislation.
“It is required to obtain written proof of such authority prior to the distribution of products to such persons or entities. Only after the receipt of a valid delivery order or material replenishment plan, the dispatch and transportation of pharmaceutical products shall be undertaken that shall be documented”, mentions the CDSCO document.
Written procedures for the dispatch of pharmaceutical products shall be established. Procedures like these will take into account the nature of any given product as well as any special precautions that need to be considered. Pharmaceutical products under quarantine shall require release for dispatch by the person responsible for quality.
Apart from the above, various other SCM challenges have been addressed by the CDSCO GDP guidelines that include deficiencies in imports, contract activities, recalls and returns and complaints. It can be hoped that with these new guidelines, the Indian pharmaceutical sector will be able to overcome majority of the supply chain difficulties in the years to come.
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