Indian Pharmacopoeia Commission (IPC) is planning to release the latest amendments to the sixth edition of the Indian Pharmacopoeia (IP) 2010 called Addendum 2012 to IP 2010 by January. The latest standards set in the amendment to the IP 2010 will be legally enforceable across the country from January 1, whereas the new monographs will be effective from April 1.
The commission has already completed its work on the addendum in early December and is waiting for the nod from the Ministry of Health & Family Welfare to release the IP 2012 addendum. The latest amendment have been made with a view to look over the licensing of manufacturing, inspection and distribution of medicines to ensure quality and efficacy of the medicines.
Dr G N Singh, secretary cum scientific director of IPC, informed that compared to last year, this year there are many strategic amendments that have been made in the IP 2010. He said, “We are putting our best efforts to raise the standard of our IP so that the drugs that are manufactured within the country gets global acceptance. During the whole process, our main focus had been to ensure sustainability of the quality of medicines which would help in promoting public health and accelerating the growth and development of pharma sector.”
Keeping in view of the essential requirement under the Drugs and Cosmetics Act, 1940 and Rules, the addendum IP 2012 has incorporated 52 new monographs consisting of APIs, dosage forms, herbal and blood products etc. in the latest IP wherein 200 monographs have been upgraded in one way or other. At the same time, this Addendum has amended and upgraded 10 and added five new Appendices the IP 2010.
Sources inform that the additions, amendments and the omissions that have been made in the addendum has been done after continuous discussions and deliberations with the regulatory authorities and other members.
Dr Singh said, “Throughout the years, we have done our best to ensure harmonisation of IP so that we can meet up with the regulatory requirements and challenges. This addendum is an effort towards achieving this task so that we can set up a system that will focus on public safety and help us in attaining a status of being one of the best IP in the world.”
IPC has been constantly engaged in collaborative activities with other pharmacopoeial commissions like United States Pharmacopoeia (USP) Convention, World Health Organisation (WHO), European Directorate of Quality Medicines (EDQM), British Pharmacopoeia Commission etc from across the world to strengthen its ties with them. In fact to get more visibility and voice in the decisions and discussions that are made at international pharmacopoeial meetings, IPC had recently urged the Pharmacopoeial Discussion Group to extend its membership to India as well.