Soon, Chemists May Face Legal Action For Non-Compliance With Storage Norms

MUMBAI, 25 NOV 2018: Consumers can now expect to get better bang for the pills they pop. The Centre is planning to introduce stringent guidelines on distribution practices for drug companies. The regulations — expected once health ministry’s expert panel, Drugs Technical Advisory Board (DTAB), approves them this week — will prevent widely-prescribed antibiotics and pain-relievers, insulins and vaccines from getting adulterated or contaminated during transportation and distribution. Significantly, once in force, stockists and chemists who fail to comply with the specified storage and distribution norms will face legal action.

At present, there are standards laid down for manufacturing, but have been practically non-existent for storage, transportation and distribution once medicines leave the company’s plant — giving rise to contamination and sub-standard medication in certain cases. There have been several instances when popular medicines, including pain-killers, vitamins, antibiotics, antiallergics have disintegrated or were sub-standard, and insulins and vaccines did not have the desired therapeutic effect, or were not effective, increasing the risk for patients.

Such issues arise if certain medicines, particularly insulins and vaccines, are not transported from the manufacturer to pharmacy through a cold chain, where essentially temperature is controlled (2°C to 8°C), or these are stored without refrigeration at the stockists’.

“The practices will ensure quality of medicines and integrity of supply chain, while preventing entry of any spurious drugs into the distribution channel,” official sources told TOI, adding these will be taken up at the DTAB meeting on November 29. The regulations, also called GDP (good distribution practices) will be notified as part of the Drugs and Cosmetics Rules.

The guidelines are to ensure quality and identity of pharmaceutical products during all aspects of the distribution process from the manufacturing plant to medical stores. These include procurement, purchasing, storage, transportation, documentation and record-keeping practices. These regulations will be applicable on all persons and outlets involved in any aspect of the storage and distribution of pharmaceutical products from the premises of manufacturer to the person dispensing or providing pharmaceutical products directly to a patient, the draft says.

The WHO good distribution practices for pharmaceutical products served as a reference for drawing up this regulation. Earlier, good distribution practices were specified only for biological products.

At present, transportation of drugs is carried out by third parties, like contractors and sub-contractors, in most cases. Also, the handling, storage and distribution involve several individuals and entities. Contamination, cross contamination, mix-ups, adulteration and presence of spurious drugs are issues in the unregulated distribution chain. Involvement of unauthorised entities in the distribution chain is also a concern. So, it’s important to have adequate control over the entire chain of distribution.The Times Of India