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May
21
ragupathyrenganathan
Health ministry to harmonise Indian Pharmacopoeia with top global pharmaceutical standards – Courtesy (Pharma Biz)
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In a move to strength the Indian Pharmacopoeia (IP) further, the health ministry in association with the Indian Pharmacopoeia Commission (IPC) is closely working with other key global pharmaceuticals standard setting bodies to harmonise the IP standards. It is understood that currently the authorities are identifying select monographs that are most similar to the other globally accepted ones to harmonise the same.

The main agenda behind this move is to harmonise with the international pharmacopoeias in few monographs in the initial stage through bilateral dialogue between the respective governments. This will not only place IP as globally accepted standards but also will ease the business opportunities for the manufacturers.

There are 39 recognised pharmacopoeia standards globally, from which IP is considered among the top few. Not only does it have largest number of monographs but also has stricter norms and limitations for impurities, with standards which are sometimes stronger than the other top pharmacopoeias, informed Dr H G Koshia, commissioner of Gujarat FDCA.

The decision to strategically explore these opportunities was taken during iPHEX, which was recently concluded in Mumbai. Dr Koshia stressed that this is a very thought out move as it will not only strengthen the image of IP in the international market but will also help boost the confidence of the industry at large.

He informed that currently Indian pharma industry caters to the needs of over 200 countries globally. While exporting to overseas market the Indian companies have to comply to either USP, BP or EP. While at the same time, they have to use the raw materials and manufacturer the same product as per IP standards when supplying it to Indian market. Once the harmonisation of these commonly used monographs is done, all that the manufacturers have to do is comply with the globally accepted harmonised pharmaceuticals standards.

“India has all the capabilities to manufacturer the highest quality of drugs at an affordable price. Most importantly, we have a heritage to support this claim coupled with a strong base in IP. Earlier, the Centre used to come out with IP standards once in many years, whereas today the IPC comes out with latest addition of IP in every two years. This stands as the greatest testament to all the great initiatives that the think tanks are taking to strengthen the Indian standards at par with any top globally accepted pharmaceutical standards,” Dr Koshia added.



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