 "Regulator comes up with draft guidelines for drug distribution")
The draft guidelines on which the authority has called for comments from various stakeholders, addresses the distribution system, starting with distribution of raw materials to procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices. It also suggests proper transportation system through which the storage conditions mentioned on the label of medicine has to be implemented including in shipping and ports, and airports infrastructure.
“We were not having a very clear defined system. Now, the Good Distribution Practices will be taking care of most of the issues which concerns the quality. We want the medicines produced at the manufacturing site the expected to have the therapeutic strength till the end point,” said G N Singh, Drug Controller General of India (DCGI).
Plans are to sensitise stakeholders, including manufacturers, distributors and the whole supply chain system and the drug regulator would discuss the policy with the state drug regulators in the next Drug Consultative Committee (DCC) before bringing in the final document, he added.
The draft suggests proper temperature, environment and storage control mechanisms and documentation throughout the supply chain. The guideline would be applicable to all parties involved in trade and distribution of pharmaceutical, including the manufacturers of bulk, finished products, wholesalers, as well as others such as suppliers, distributors, government institutions, international procurement organisation, donor agencies and certifying bodies, logistics providers, traders, transport companies and forwarding agents and their employees as well as health workers, it says.
“Procedures shall be in place to ensure safe, transparent and secure distribution system which includes product traceability throughout the supply chain. There shall be procedures in place to ensure document traceability of products received and distributed, to facilitate product recall,” says the guideline.
The transportation routes have to be planned on a risk-based approach to demonstrate that the products have not been subject to conditions during transportation that may compromise their quality.
“It is the responsibility of the distributor to ensure vehicles and equipment used to distribute, store or handle pharmaceutical products are suitable for their use and appropriately equipped to prevent exposure of the products to conditions that shall affect their quality and packaging integrity, and to prevent contamination of any kind,” it adds.
The manufacturer has to select the distributor who has the capability to deliver the product under these standards, said Singh and the cost of transportation with facilities according to this has to be finalised between the manufacturer and the distributor, said Singh. “But it is the ultimatly the manufacturers’ responsibility to see that he may have such distributors or the outlets or the other things so that the medicines being manufactured reaches the patient in a condition same to the label claim which has been made,” he added.
The regulator would also start dialogue with the retailers to spread awareness of maintaining storage conditions as per the recommendations in the label, to maintain the quality of the product.