Union health ministry to introduce bar coding on APIs for quality – The Tribune
Ambika Sharma
Tribune News Service
Solan, November 29
The Ministry of Health and Family Welfare will soon introduce bar coding on active pharmaceutical ingredients (APIs) to ensure the availability of quality material to the industry.
Manufacturers had been raising the issue of the lack of quality API availability as traders were re-labelling and re-packing the original product after its import. The industry is heavily dependent on China, which supplies 65 per cent APIs to the domestic industry.
Several pharmaceutical manufacturers, including the Himachal Drug Manufacturers Association (HDMA), had taken up the issue with the ministry.
Joint Drug Controller, Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare, Eshwara Reddy, said, “The Drug Technical Advisory Committee has recommended bar coding on API labels and this will ensure genuineness of the product. This will make available the QR code, which can be scanned to obtain the details of manufacturer like batch number, date of manufacturing, etc.
The ministry has approved the bar coding on active pharmaceutical ingredients and its notification will be issued soon.”
SL Singla, Adviser, HDMA, said, “Though pharmaceutical manufacturers are supposed to use API meant for Indian Pharmacopoeia but instances have come to the fore where API under the food grade and not meant for use in medicines has been supplied.”
Apart from ensuring that the GST is paid on a batch of the API, there is little control over its trading. Re-packing and re-labelling of APIs by local traders enhances the chances of its quality being compromised upon and measures like bar coding and the scanning of the QR code will help a manufacturer check its authenticity.
Since the manufacturers have little facility to test the active pharmaceutical ingredients at their end, small manufacturers, particularly who operate on credit, face problems in getting quality APIs, said other manufacturers.
