With an aim to monitor benefit and risk profile of medicines, the Union ministry of health recently appointed the Indian Pharmacopoeia Commission (IPC) as the National Coordinating Centre (NCC) for Pharmacovigilance Programme of India (PvPI). The main aim of the NCC at IPC will be to generate an independent data on the safety of medicines that will be at par with global drug safety monitoring standards.
The Centre at IPC will mainly focus on developing India's own data base on drug information and ADR's so that India will not have to be dependent on data from other countries to take decisions relating to banning and suspension of drugs. According to a reliable source from the Pharmacopoeia Commission , “As of now we do not have a strong data base on ADR's within India and have to depend on information from others. We want all the medical institutions, hospitals, colleges, public health programmes in the country both government as well as private to take part in the pharmacovigilence programme and report on ADR's to us at IPC so that we can have all the data at one place.”
The centre will be operating under the supervision of a steering committee and a working group. The steering committee will consist of five members and will be headed by Dr Surinder Singh, Drugs Controller General of India (DCGI). Whereas, the working group will be headed Dr G N Singh, secretary and scientific director, IPC with five to six members in it.
Prior to IPC, this programme was coordinated by the Department of Pharmacology, AIIMS as a NCC.
An industry insider informs, “The decision to make IPC as the new NCC was taken by the government after lot of deliberations and meetings keeping in mind the overall development of the PvPI. As a standard setting body for medicines in the country IPC is the most qualified body to handle this responsibility. But most importantly, even logistically IPC was considered as the best to handle the issues relating to pharmacovigilence.”
IPC is also working towards having good business relation with other international monitoring bodies as well so as to ensure that India has a greater role in reporting of ADR's. Industry insiders inform that with a view to establish a centre of excellence for pharmacovigilance in India the NCC has plans to collaborate with the WHO-Uppsala Monitoring Centre (UMC) which is based in Sweden.
Having collaboration at this level will enable India to access Vigibase, which contains worldwide medicines safety data and get early information about potential safety hazards of medicines worldwide data. Interestingly, Vigiflow software provided by WHO-Uppsala Monitoring Centre will be utilised as the safety database, where all data originating from India will be maintained in a secure and confidential manner.
Among other initiatives, IPC is at present focusing on publishing an Addendum 2011 of the IP 2010 and it is also planning to publish the final print of the National Formulary of India (NFI) by September 2011. NFI is a publication that contains guidelines on right dosage of medicines for drug prescribers and is expected to be availed soon for doctors, chemists and nurses in its revised form.
One of the most important mandates of the IPC is to publish the Indian Pharmacopoeia which is the legally recognised book of standards for monitoring the quality of drugs and pharmaceuticals as per the Drugs and Cosmetics Act, 1940 at regular and shorter intervals.