New norms likely for drug distribution and storage

The government is reportedly 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 – 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 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 – giving rise to contamination and sub-standard medication in certain cases. There have been several instances when popular medicines, including pain-killers, vitamins, antibiotics, anti-allergics have disintegrated or were sub-standard, and insulins and vaccines did not have the desired therapeutic effect.

Such issues arise if certain medicines, particularly insulins and vaccines, are not transported through a cold chain, or stored without refrigeration at stockists.

The regulations, called GDP (good distribution practices), will be notified as part of the Drugs and Cosmetics Rules. The WHO GDP for pharmaceutical products served as a reference for drawing up this regulation.