Maharashtra FDA soon to make provision for issuance of e-licensing of cold storage delivery vehicles for drug distribution

The Maharashtra Food and Drug Administration (FDA) has finally decided to make provisions for issuance of online licensing of cold storage delivery vehicles for drug distribution in the drug retail supply chain. Pharmacy trade has been contesting the issue that online licenses for vehicles having cold storage for delivery of medicines at retail drug stores have not been issued in the past five years as the online system neither has provision nor any format on the same. “We will be making necessary provisions for online licensing of cold storage delivery vehicles by next month,” informed Maharashtra FDA Commissioner Dr Pallavi Darade. The Maharashtra FDA in 2014 had introduced XLN online licensing system for online disposal of licenses. There is a provision for obtaining 20 BB and 21 BB licenses under Drugs and Cosmetics (D&C) Act for bulk drug delivery through vehicle license. As per the provision, the state drug regulator can keep an oversight of the drug supply chain right from the wholesaler and C&F agents authorised by pharma companies to the retail drug store for patient safety. The online XLN system was introduced in 2014 across the state in order to accomplish timely disposal of renewal licenses, testing licences, licences for additional products, performance certificate and free sale licences among others but the online system has no format and provision for online application of cold storage licenses for delivery vehicles which is an indispensable part in drug supply chain system. This has posed serious doubts about the efficacy and quality of medicines in the supply chain due to lack of effective compliance as provisioned under the D&C Act, 1940 and Rules, 1945. The delivery vehicles are supposed to have cold and cool temperature maintained in their vehicles for over 2,000 types of medicines during the course of its journey to the respective drug retail pharmacy. For this, they have to secure a license for the same through online application mandated by the state food and drug administration. According to drug regulatory experts, “Under this license, Department of Pharmaceuticals (DoP) registers a vehicle to be used during bulk drug distribution.” The license mandates wholesalers to maintain temperature of the drugs at 2 to 8 degree celsius and 8 to 25 degree celsius for medicines to be kept in cold and cool storage temperatures as specified under the law during transport to the retail drug store. Following manufacture, some medicinal products need to be stored and shipped at lower than ambient temperatures to assure their quality and efficacy. These are often referred to as “cold chain products”.

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