The Indian Pharmacopoeia Commission (IPC) has identified 133 drugs for preparation of reference standards on a priority basis. The commission is to work on the preparation of stringent standard operating procedures and protocols for the preparation, distribution and characterization of these reference standards.
According to IPC sources, the SOP would derive much from the WHO guidelines available. "The base line would be derived from the WHO reference standard guidelines and the work is to be assigned to all organizations that are capable of doing the work" sources informed. IFPRESS Mumbai, (Indian Foundation) and CDL, Kolkata are among the major institutions that have the capability to take up the job, it is learnt.
IPC has a long-term vision of having in place 600 reference standards in a phased manner. The commission is known to have asked organizations like Indian Drugs Manufacturers Association (IDMA), Bulk Drugs Manufacturers Association (BDMA), Ayurvedic Drug Manufacturers Association (ADMA) and Organisation of Pharmaceutical Producers of India (OPPI) to join hands with IPC in this regard. The commission has also sought the help of industry associations to announce the arrival of IP Addendum to its members.
The commission envisages developing India as a supply base for reference standards to the world and thereby turning it into a revenue model for the commission. The role of IPC would be to set the standards and get it procured from active ingredient manufacturers of the country. The IPC would then purify, characterize, containerize, certify and distribute the reference standards to the stakeholders.
The IPC claims to have chalked out a clear-cut strategy to start production of the entire range of reference standards within a time frame of five years. The idea is to have 40 per cent of the reference standards made indigenously available within two to three years. According to IP experts, around 200 - 300 reference standards are the ones most needed by the industry.
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.
As Pharmabiz reported, the Union Finance Ministry has proposed the withdrawal of customs duty exemption granted to pharmaceutical reference standards imported into the country. The move is in line with the government's stated policy to broaden the tax base through withdrawal of exemptions. There are about 600 reference standards that are being imported by the pharmaceutical industry. While the withdrawal of duty exemptions would make import costlier, it may indirectly help the plans of Indian Pharmacopoeia Commission (IPC) to begin indigenous production and sale of reference standards.