Indian Pharmacopoeia Commission (IPC) is going to release the Indian Pharmacopoeia (IP) 2010--Sixth Edition, which is in print, in three months. IPC, under the Union Ministry of Health has now started working on the Addendum to IP 2010, as decided in its Scientific Body’s meeting held on May 1.

At present the Indian Pharmacopoeia does not have much provisions relating to excipients and IPC has recognised the need, which has triggered this move. “One of the important areas that IPC has decided to work on is to strengthen the quality standards for excipients. The IP 2010 edition thus will have twenty one new monographs on excipients and the addendum is going to focus further on this critical area,” informed Dr D B A Narayana, member of the Scientific Body, Indian Pharmacopoeia Commission.

In a meeting held in Delhi on May 1 it was decided by the IPC to address this in the addendum. Speaking about this Dr Narayana, said that work on the addendum has already begun. He averred, “It is important to focus on excipients and its quality since any compromise on the same can adversely impact the stability of the drugs.”

In India excipients are largely imported and some of the excipients are manufactured within India. The excipients that are imported are tested according to the pharmacopoeia of the country manufacturing it. At present, the Indian Pharmacopoeia does not specifically address this segment fully, thus the pharmacopoeia commission felt the need to review and prepare new monographs and add it accordingly.

According to Dr Narayana, once the addendum work starts, the excipients that are imported in large quantities need to be looked into. Similarly, those excipients that are known to be more critical for quality will also need to be assessed. He said, “The pharma companies are required to inform the pharmacopoeia commission about the excipients manufactured in India, and about those that have no IP monograph.” The pharmacopoeia wants the stake holders to work with the commission so that they can keep a better tab on the quality of the drug.

The Indian Pharmacopoeia is the official book of standards and medicines produced in India, and the companies must comply with the specified quality standards. Pharmacopoeial standards and acceptance criteria are set with the intention that they be used only as compliance requirements and not as requirements to guarantee total quality assurance. The main aim is to promote public health in India by bringing out authoritative and officially accepted standards for quality of drugs including active pharmaceutical ingredients, excipients and dosage forms, used by health professionals, patients and consumers. The Indian Pharmacopoeia Commission (IPC) has been formed as an autonomous institution under the Ministry of Health and Family Welfare’s on 2008. It is dedicated for setting of standards for drugs, pharmaceuticals and health care devices/technologies etc besides providing reference substances and training.