With a view to streamline and ensure the quality of drugs during transportation, the government is planning to bring in legislations and penalise the offenders.
As part of this, the Drugs Controller General India (DCGI) has come out with draft guidelines on ‘Good Distribution Practices’ (GDP) for pharmaceutical products. The 54th Drugs Consultations Committee meeting in end-July had suggested, taking necessary provisions to impart legal sanctity to the suggested guidelines in the rule book Drugs and Cosmetics Rules 1945, to penalise the offenders. The DCGI has asked all related stakeholders to respond to the draft guidelines to finalise the legislation, said sources.
At present the Rules 64 and 65 of the rule book vaguely suggest the conditions to be fulfilled to sell, stock, exhibit or distribute drugs.
At present transportation of drugs are carried out by third parties like contractors and sub-contractors in most cases. Contamination, cross contamination, mix-ups, adulteration and presence of spurious drugs are an issue in the unregulated distribution chain. Involvement of unauthorised entities in the distribution chain is also a concern.
The guidelines are to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. These include procurement, purchasing, storage distribution, transportation, documentation and record keeping practices in the chain from the manufacturing plant to the medical stores.
The draft guidelines suggest there will be collaboration and an agreement in place with all the agencies involved in the storage, distribution and transportation. The distributor and the organisation he belongs to shall be held responsible for the activities that it performs related to the distribution of products. Export and import of pharmaceutical products will require appropriate licenses and drug distributors and subcontractors will require authorisation. Besides training the people in the distribution chain as per pre-defined standard operating procedures (SOP), managements will have to ensure safety standards for people and property, environment and product integrity. Protective garments have to be given to people handling hazardous materials.
The guidelines will mandate a documented quality policy, detailing intentions and requirements of distributors regarding quality, authorised by the management. Various jobs in the distribution chain will be detailed and will require an organisational chain. Procedures for procurement and release shall be in place to ensure pharmaceutical products are sourced from approved suppliers and distributed by approved agencies. Procedures will be in place to ensure documentation so that the products are traceable in the supply chain and help in monitoring product recall.