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GDP GUIDELINES
P A Francis | Wednesday, February 6, 2013, 08:00 Hrs  [IST]

Like good manufacturing practices, proper transportation and storage of drugs are the other two key factors that ensure the potency of the drug till it is reached the ultimate consumer. Drugs whether they are vaccines, antibiotics or even analgesics have to be stored and transported in prescribed temperature conditions to maintain their efficacy. The need for proper storage of drugs starts from the manufacturing locations where godowns of pharmaceutical companies are usually situated. The quality of drugs can get seriously affected during the transportation from the factory to C&F agents, wholesalers and finally to retailers if they are carried in open trucks exposed to sunlight and humid conditions. Constant exposure to temperatures above 30 degree centigrade for a few days can substantially degrade the antibiotics and vitamins. Therefore transportation of all drugs has to be under refrigerated vehicles until they reached the final destinations. This has not been happening in the country as several small drug companies and C&F agents do not use refrigerated facilities for drug transportation and storage.

The union health ministry’s decision to issue a set of draft guidelines on good distribution practices for pharmaceutical products early last month is with the intention of bringing some order on this critical front of this business. The GDP guidelines seek to ensure the quality and identity of pharmaceutical products during all phases of  distribution process like procurement, purchasing, storage, transportation and documentation. As per the Guidelines, it will be the responsibility of all parties involved in the distribution of pharmaceutical products to ensure that the quality of pharmaceutical products and the integrity of the distribution chain are maintained throughout the distribution process. That is from the site of the manufacturer to the entity responsible for dispensing or providing the product to the patient. The drug control authorities usually hold pharma companies and chemists responsible for the not-of-standard quality products in the market. What is to be understood is that the C&F agents also have a decisive role in maintaining the potency of the drugs and they have to be made accountable. Although most of the C&F agents have refrigerated storage facilities, the vehicles they use are ordinary tempo trucks for carrying medicines to the chemist shops especially in semi urban and rural areas. This needs to be stopped and  transportation of all drugs should be allowed only in refrigerated vehicles. The health ministry seeks to bring this much needed reform in drug distribution and storage practices through the GDP draft guidelines. Now, the pharmaceutical industry and trade have to support the government for a faster and effective implementation of these guidelines for the public good.

Comments

Anil Feb 13, 2013 3:44 PM
The crux of the issue is the cost factor, space factor and expenditure involved in maintaining the temperatures at various points of storage like cost of generator and fuel, 24 hours 360 days running of ACs, Deep Freezers and cold rooms i.e. refrigerators, walk-in-coolers etc.,
There is also a need for perpetual education of end user for proper storage at his house and Distributor, Retailer with regards to maintenance of Depot s/ Shops.
Last but not least, The Government should consider to compensate or make a provision in the cost towards logistics and distribution which is not given a due consideration during past and now to be considered or in other words it is a neglected area and to achieve desired results, Government should seriously consider making higher provision, on cost towards the expenditure, to the manufacturer as well as to the all partners in the supply chain i.e. at depot, whole sale and Retail levels with a clause of strict compliance of the provisions and h

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