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FOPE & KDPMA advocate speedy implementation of GDP norms to ensure control over entire distribution chain
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Nandita Vijayasimha, Bengaluru
April 18 , 2024
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The Federation of Pharma Entrepreneurs (FOPE) and the Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) are advocating for the swift implementation of GDP (Good Distribution Practice) norms to ensure proper control over the entire pharmaceutical distribution chain.
GDP norms are crucial in maintaining the quality and integrity of pharmaceutical products throughout their distribution process. Adhering to these standards helps prevent issues like contamination, counterfeiting, or improper handling that could compromise the effectiveness and safety of medications.
By pushing for speedy execution, FOPE and KDPMA see that this would see stringent regulatory compliance and safeguard public health in supply chain and distribution.
Harish K Jain, president, FOPE and director, Embiotic Labs, said that pharmaceutical products by law are mandated to be safe & efficacious till the end of shelf life. Quality is now defined in terms of quality of the product in the hand of the patient. Keeping this aspect in view introduction of GDP guidelines is long overdue. In fact, in many of the developed countries it is mandatory to follow GDP end-to-end from procurement of inputs till the medicine reaches the patient.
On a similar note, Manoj Palrecha, president, KDPMA and managing director, Lake Chemicals said that the GDP is on similar lines that of the GMP or Schedule M which are mandatory adherences in pharma manufacturing. There are lots of steps to be looked into before a medicine reaches the patient. Manufacturing of medicines is just one part of it. Factors like cold-chain distribution, supply chain transparency and pharmacy outlets storage methods come to the fore.
Proper temperature control is critical to prevent disintegration of tablets and capsules or spoilage of syrups, rendering them less effective or even harmful to patients. Considering the fact that many pharmacy outlets and logistic sector are not equipped with the necessary technology for temperature monitoring, there is need for close surveillance of such shortcomings. Government needs to devise a mechanism to ensure compliance and accountability. Implementing a system for inspection by drug enforcement officers would not only help identify and rectify issues and foster transparency and trust.
Jain said that pharmaceutical API, excipients, packaging materials & finished products needs to be of specified quality as well as free from extraneous materials and in order to achieve that storage & transportation should be in clean environment with control over temperature, light & humidity. Needless to say these products should be handled only by competent staff and proper records maintained.
Recently, many instances of spurious and duplicate products have surfaced in our country. All these could have been minimized if there was proper GDP in place in our ecosystem. Nevertheless, GDP is a welcome step and will result in improvement in trust & quality of products in the hands of patients since many a times quality deteriorates in supply chain due to inadequate infrastructure and products not being handled competent staff in the supply chain. GDP will also minimize instances of pilferage as well as entry of spurious drugs in supply chain, noted Jain.
The industry would like GDP to be made mandatory as soon as possible with due consultation with all stake holders for smooth implementation, said the FOPE president.
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