With a view to ensure better understanding of the Indian Pharmacopoeia (IP) by all the stakeholders, the Drug Controller General of India (DCGI), Dr G N Singh released the much anticipated guidance manual for compliance of Indian Pharmacopoeia (IP) in Ghaziabad on December 12. This manual was prepared and published by the Indian Pharmacopoeia Commission (IPC) in collaboration with Central Drugs Standard Control Organisation (CDSCO) and WHO-country office for India after extensive discussions and deliberations with the experts from this field.

This guidance manual a first of its kind for pharmacopoeial standards in India, was drafted with an aim to enable the regulatory bodies to discharge their duties as well as to streamline the functions of their own laboratories and also the in-house laboratories of drug manufacturers and commercial drugs testing laboratories. The document contains details on IP 2010 and addendum 2012 along with its salient features, good laboratory practices (GLP) along with schedule L1 and its interpretation, reporting of errors and anomalies in the IP, guidelines to users of IP, process of IP monographs development guidelines for stability testing of drug substances active pharmaceutical ingredients (API's) and drug products i.e. finished pharmaceutical products etc. along with other gamut of information that will be beneficial to the manufactures.

According to Dr Jai Prakash, principal scientific officer, IPC, the need for publishing this guidance document was felt by the commission after they observed on several occasion that the stakeholders were not sensitised nor well informed about the IP requirements as mandated. This they found out after several interactions with the stakeholders during many IP related meetings and symposia organised by the IPC over the couple of years.

He reinforced, “Considering the situation it was deemed to be of utmost importance to ensure a platform that will enable the stake holders to better understand the pharmacopoeia. Through this initiative we aim to ensure easy availability of all the IP related information and data to the interested stakeholders that will enable them to understand and interpret the monographs and other IP related technical data more easily at an affordable price of Rs.300 from our IPC office.”

Dr Singh who is also the secretary-cum-scientific director of the IPC stressed that considering the lack of understanding about the information of the IP among the stakeholders, it was felt necessary by the IPC officials to provide a detailed and simplified version of the same in the form of a guidance document for the over all benefit of the stakeholders. Dr Singh further emphasised with a view to ensure efficient implementation of current standards of IP, it is very essential to ensure that all manufacturers are first well sensitised and educated about the same. As only with such proactive stance can India ensure to make IP at par with other international bodies such as BP, USP etc.

He stressed, “Unless the norms prescribed in IP, the officially recognised book of standards for drugs as per the Drugs and Cosmetics (D&C) Act 1940 and Rules 1945, are understood and adopted by the stakeholders, the purposes of the publication of its new version may to not be achieved. This manual is not an addendum or supplement to the IP or a part of it. However it is intended to enable the users of IP to perform the activities related to performance of the tests or associated activities prescribed in the IP and also to understand or interpret the requirements of IP for proper compliance of the requirements thereof.”