The Indian Pharmacopoeia Commission (IPC) has finalised the list of 133 reference standards that are to be made available to the stakeholders by year end. In a meeting with the technical committee members of the Indian Drugs Manufacturers Association (IDMA) on September 29, IPC representatives are known to have secured the industry approval its choice of reference standards.
According to sources, the meeting also identified the list of bulk drug manufacturers who should be asked to supply the APIs for preparation of reference standards by various government and private agencies. "Its going to be a public-private partnership. India will be in a position to supply reference standards in a couple of months time,"sources said.
The IPC has already prepared standard operating procedures and protocols for the preparation, distribution and characterization of these reference standards. The baseline for the SOPs has come from the WHO guidelines available. IFPRESS Mumbai, (Indian Foundation), CDRI Lucknow and CDL, Kolkata would be asked to take up the job, it is learnt.
As reported, 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 envisages to develop India as a supply base for reference standards to the world and thereby turn it into a revenue model for the commission.