Pharma logistics: A victim of negligence

It is strange that pharmaceutical manufacturers concerned about their company’s reputation continue to turn a blind eye on the state of their goods hitting the market, says Dr W V Lawate

The drug manufacturers in India, big or small, are required to practice very high standards of GMP during manufacture and satisfy very strict quality assurance requirements of the finished products. Having done so in the best possible manner, the moment a manufacturer releases his finished goods stocks for distribution to the market, the transporter takes over the responsibility of reaching the goods to company depots or distributors’ godown.

The personnel concerned with this activity totally ignore the fact that medicines need to be treated very carefully as the consignment passes through various stages of handling and transport. For them, these items merely represent one of the “goods” they are routinely handling. Special care warranted to these materials are not at all their concern. This is particularly important in the case of long distance destinations, often requiring transhipments on the way.

Much has been said and written about Good Storage Practices (GSP) and Good Trade Practices (GTP). It appears that the updated versions of WHO guidelines and Indian Guidelines on GSP are still forthcoming. As and when these guidelines are published, the feasibility of effective implementation of the provisions of the guidelines would be termed as a serious problem. Awareness, accountability of responsibility and avoidance of negligence would be required to be imbibed in the present system. Some time ago Delhi Pharmaceutical Trust Report has revealed in their survey many irregularities in the drugs storage practices in Delhi. Tamil Nadu state FDA authorities have also noticed several deficiencies in the product storage system in the state. Other states have probably not carried out such surveys, but the outcome will be presumably very much on the same lines.

A recent report of Karnataka state vigilance agency revealed that the Mahanagar Palika Drug store was found to be in a mess. The mentioned store was meant for supplying goods to 35 hospitals and 23 maternity homes. Large quantities of drugs were found to be substandard and several of them past their expiry dates. Besides, the quantity of many drugs were in excess than that has been recorded in the books. Many drugs were infected with fungus and some packs did not bear government seals. The store was not being supervised by a competent, qualified and approved pharmacist. It appears that the concerned authorities could not give any explanation for all the above drawbacks.

Although it may not have been reported, other problems such as improper segregation of goods, inadequate cold storage facilities, neglected first-come-first-use system are some of the more evident irregularities.

It is worthwhile to mention that the manufacturers, who care so much for their company’s image and reputation do not practice effective post marketing surveillance to weed out near expiry goods. For this purpose, a local area field staff should be instructed to conduct a survey of the current storage system at regular intervals and insist on proper follow-up of recommended practices. The necessary permissions and authorities may not be too difficult to obtain for the above type of vigilance.

The responsibility of Indian drug authorities in the above respect is paramount. Having received the type of reports mentioned above and considering that many more may have not come to light, a comprehensive policy, suitable for Indian conditions and taking into consideration the Indian mentality needs to be urgently worked out in consultation with the industry representatives. The present situation is already causing heavy damage to healthcare effort in the country and if such irregularities are permitted to continue, the situation might reach an irreparable and grievous stage, practically to a point of no return.

The writer is Mumbai-based consultant