Continuing with its commitment to improve the health of the people by ensuring quality, safety and efficacy of medicines, the Indian Pharmacopeia Commission (IPC) released its IP Addendum-2015 to IP-2014 last week in Delhi. Addendum 2015 to IP 2014 incorporates 82 new monographs consisting of 57 chemical monographs, 13 herbal monographs, two human vaccines monographs and 10 radiopharmaceutical monographs, six revised monographs, 29 revised tests and about 20 new IR spectras.

It also contains information on drug substances, monographs on vaccines and immunosera for human use, herbs and herbal products, and radiopharmaceutical preparations. The Addendum 2015 of IP 2014 published by IPC is expected to play an important role in improving the quality of medicines, which in turn will ensure promotion of public health, while accelerating the growth and development of the pharma sector.

Dr Raman Mohan Singh, principal scientific officer, quality manager and coordinator, Indian Pharmacopoeia Laboratory, IPC, informed that the Addendum is published in accordance with the principles and designed plan decided by the scientific body of the IPC. In fact, post its release in Delhi, the Addendum was officially launched on December 3 at the 29th scientific body meet at IPC Ghaziabad.

He said, “IPC is constantly working towards upgrading the IP, so that it can benefit the public and the stakeholders. In fact keeping in lines with this we have already stared the work on addendum 2016.” Dr Singh further informed that as per their ongoing process IP has added 52 monographs in new IP of which 32 are already available for the stakeholders online, while the rest 20 will be added shortly, by end of December this year.

Highlighting some of the important changes made in the Addendum, Dr Singh states general chemical tests for identification of an article have been almost eliminated and more specific infrared and ultraviolet spectrophotometric tests have been given emphasis.

However, the concept of relying on published infrared spectra as a basis for identification has been continued. Similarly the use of chromatographic methods has been greatly extended to cope with the need for more specificity in assays and in particular, in assessing the nature and extent of impurities in ingredients and products.

Further he added, most of existing assays and related substances tests are upgraded by liquid chromatographic method in view to harmonise with other international pharmacopoeias. Dr Singh pointed out that all the decisions have been taken after reviewing the comments by relevant expert committee to ensure the feasibility and practicability of the standards and methods revised.

This Addendum has the same authority as the IP 2014, which was published in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder. It prescribes the standards for drugs produced and or marketed in India and thus contributes in the control and assurance of the quality of the medicines.