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Best practices not followed consistently across pharma supply chain due to lack of GDP guidelines: Expert

Shardul Nautiyal, Mumbai
Thursday, March 4, 2021, 08:00 Hrs  [IST]

Best practices are not followed consistently across pharmaceutical supply chain in India due to lack of Good Distribution Practices (GDP) guidelines and other regulations, according to experts.

Currently, there are no mandated GDP norms issued by the Central Drug Standards Control Organization (CDSCO). Additionally, the distribution across the supply chain is very fragmented. Therefore, capability and resources available vary to a significant degree.

Experts have further revealed that lack of regulation and enforcement also provides room to cut corners in the search of minimizing costs at each level. Hence, compliance checks should be conducted regularly to eradicate such practice.

“Additionally, by breaking up retail packs often at consumer request and selling for example a partial drug strip, traceability is lost completely. For such partial retail packs no record can be maintained of which part was sold to which customer. Also in the consumers hands such broken packs will often not have batch and expiry details, besides sometimes even losing the product name details,” according to Ravindranath Menon, senior business adviser, APAC Healthcare, South India, Nexdigm (SKP).  

This places the consumer at a risk of using the wrong or expired medication. Also in case of a recall the patient cannot be reached to inform about the recall or any mitigation procedures. Proper regulation and compliance at each level will go a long way to ensure patient safety.

Over the past few years, the pharmaceutical industry in India has been making consistent efforts to upgrade distribution practices across the country in terms of establishing SOPs, improving storage and transport infrastructure and systems, monitoring of storage and transport conditions, improvement of cold chain capability, documentation, and control etc. Many of the organisations audit their own practices and those of their partners to ensure adherence and improvement.

“It is crucial that all parties in the supply chain are identifiable which allows us to track batch numbers at each level of the distribution. At each level, the hand-of-product and transaction is documented and kept in records as per national regulations. Hence, each Stock Keeping Unit (SKU) needs to be traceable at both distributor and retailer level. This will require adoption of digital technologies across the supply chain. Additionally, it is essential that the retailer record patient details when selling the product so as to track which SKU went to which patient. This will help full traceability and facilitate robust recalls if and when needed,” informed Menon.

Public procurement is a complex process which is executed by multiple ministries, departments and public sector organisations. Different buyers in the public procurement system often have varied policies and procedures driven by historical and economic compulsions.

“Hence, it is important that we bring in consistency and efficiency into the procurement system. The central tenet underlying practices/procedures should be to ensure quality and reliability and guarantee that recipients of the products in the public procurement system get the same quality as that in the private market.  There need to be rigorous standards around vendor qualification and product quality that must be complied with as a basic qualifier,” Menon added.

India has over 10,000 manufacturing facilities. Most pharmaceutical companies have a network dependency on 20 to 25 carrying and forwarding agents (CFAs). The downstream supply chain consists of nearly 65,000 distributors and 5.5 lakh pharmacists. The supply chain is complex and fragmented. There is huge variance in infrastructure and workforce available across the distribution network which leads to significant gaps in processes and systems.

“Hence, it is crucial to invest in building infrastructure in semi-rural and rural areas, training man-power and building a culture of compliance which will lead to uniform availability of quality drugs across the length and breadth of the country,” Menon concluded.

 

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