Indian Pharmacopeia Commission (IPC), which launched the IP Addendum-2015 to IP-2014 in early December, has decided to extend the implementation date of IP Addendum-2015 from 1st January, 2015 to 31st March, 2015 in the 29th Scientific Body meeting held in December, 2014 at IPC, Ghaziabad. Now this IP Addendum-2015 will be effective from 1st April, 2015. The decision to extent the date was taken following the demand from the stakeholders of Indian pharmacopoeia.
Dr Raman Mohan Singh, principal scientific officer, quality manager and coordinator, Indian Pharmacopoeia Laboratory, IPC, informed that in view of the late releasing of this Addendum and the subsequent demand from the stakeholders asking for some time, IPC has decided to take this stand.
He stressed, “Our main aim is to ensure proper implementation of the IP by the stakeholders so that it will ensure availability of high quality drugs for the patients. After going through their representation, we felt that it was only feasible and acceptable to give them time, since it has been prepared for them. Moreover, IP intends to help in the licencing of manufacturing, inspection and distribution of IP and its Addendum are published in continuing pursuit of the mission of IPC to improve the health of the people through ensuring the quality, safety and efficacy of medicines. Through this move, we want to ensure the stakeholders that we aim to work with them in all our endeavors. Thus to make it as per the availability to the stakeholders, we have extended the effective date suitably as deemed fit by the scientific body of IPC.”
Interestingly, the Addendum 2015 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 IP is published in compliance with the requirements of the Drugs & Cosmetics Act, 1940 and Rules, prescribing the standards for drugs produced and or marketed in India and thus contributes in the control and assurance of the quality of the medicines. Dr Singh informed that the Addendum is published in accordance with the principles and designed plan decided by the scientific body of the IPC.