Keen to focus on setting the quality standards of vaccines throughout the country, the Indian Pharmacopoeia Commission (IPC) released the much anticipated national reference standards, the Indian Pharmacopoeia Reference Substances (IPRS-Vaccines). This is a first of its kind initiative by the IPC to fulfill the intended purpose of the having IP monographs, the national reference standards for various vaccines, and further reinstates IPC’s growing interest in giving special emphasis on standards of ‘vaccines and immunosera for human use under IP.

The IPRS-Vaccines was released during the 5th expert committee meeting on vaccines standards for IP which was conducted in collaboration with the Central Drugs Laboratory (CDL), Kasauli at Kasauli, Himachal Pradesh. It was released in presence of representative from DCGI office Dr A Ramkishan, deputy drugs controller (India), Central Drugs Standard Control Organisation (CDSCO), Dr Arun Bhardwaj, director, CDL, Kasauli, Dr A K Tehlan, director, Central Research Institute, Kasauli and representative from IPC, Dr Jai Prakash, senior principal scientific officer, IPC.

IPC which sets quality standards of drugs and their formulations by publishing Indian Pharmacopoeia (IP) has been working with CDL, the national control laboratory in respect of vaccines over sometime. “The IPRS-Vaccines are vital in ensuring the quality as well as the consistency of production of vaccines in the country and to reduce inherent variability due to biological system used for production of vaccines. We are very excited with this development and are looking forward to expand its scope further,” said Dr Jai Prakash.

Vaccine is a biological preparation that stimulates the bodies immune system and protects the body against any infectious disease, thus putting the role of vaccines beyond prophylaxis use, informed experts. Interestingly, to fulfill the needs of quality vaccines in the country through IP, IPC and CDL also had a high level meeting post the launch to discuss and deliberate over the requisite steps to be taken to strengthen this initiative in the future as well.

Apart from experts from the IPC and the CDL, the meeting was also open to select stakeholders from various vaccines manufacturing units of the country including representative from PETA (India) and regulatory officials. Dr Jai Prakash further informed that the experts collectively agreed that it was utmost essential to make some amendments in the existing ‘vaccine and immunosera for human use’ monographs of IP in line with the international trends. Especially since it is essential to facilitate the acceptability of Indian vaccines at international level. He said that the meeting also discussed on the draft of new vaccine monographs like pneumococcal polysaccharide conjugate vaccine, scorpion venom antiserum in detail.