The newly constituted Indian Pharmacopoeia Commission (IPC) has plans to enter into reference standards preparation in a big way. The IPC has a long-term vision of having in place 600 reference standards over a period of time. The commission has decided to be ready with 50 reference standards within next six months, it is learnt. The number would touch 100 by one-year and would gradually increase to 600.

According to official sources, reference standards and impurity profiling are going to be the major areas of interest for the IPC. While the IP Committee had been engaged in the task of preparing monographs and publishing IP, the IPC would extend its activities to areas like reference standard preparation. The IPC also believes that India is capable of supplying reference standards to the world and thereby turning it into a revenue model for the commission.

In its attempt to turn self-sustaining, the commission may also request the government to make possession of the latest addendum/edition of Indian Pharmacopoeia a legal requirement for all testing laboratories, pharmaceutical companies and research institutions of the country. The need for a legal backing was felt after it became clear that bulk of the IP published earlier had never reached the drug manufacturing facilities across the country.

Agencies like US Pharmacopoeia are known to be making lots of money through the sale of reference standards. Though this revenue model is yet to gain strength in India, it may soon attract agencies keen on outsourcing their reference standards from India.

Reference standards establishes the finger prints of each drug molecule for medicaments which needs to be made before any drug is put in use in the territory of governance of any pharmacopoeia. To begin with, IPC would seek help of all existing institutions that have necessary facilities for the preparation of reference standards. IFPRESS Mumbai, (Indian Foundation) and CDL, Kolkata are major institutions that have the capability to take up the job now.