The Commerce Ministry has excluded bulk drug (active pharmaceutical ingredients) exports from the mandatory bar coding, which came into effect last month, based on the industry plea that they are just inputs used to make formulations.
The ministry had introduced trace and track system for pharmaceutical exports primarily to check the menace of counterfeits with 'Made in India' tag in Africa and elsewhere that were threatening the brand image and quality of Indian drugs in the international market.
Under this mandate, pharmaceutical exports should carry a three-level bar coding -- on strips or bottle, secondary level pack and on shipper/carton or tertiary level pack -- in a phased manner. Currently, companies have started using bar coding at the tertiary level packing while the other two levels have to be introduced later next year.
“The ministry has already agreed to exclude bulk drugs from the trace and track system as they are not finished products. We are talking to Customs department officials to see that they do not insist on bar coding on bulk drug exports,” PV Appaji, executive director of Pharmaceuticals Export Promotion Council (Pharmexcil), told Business Standard.
Bulk drugs account for 45 per cent of the total pharma exports from India while the rest are formulations or finished pharmaceutical products.