Indian Pharmacopoeia Commission (IPC) planning hard to organize ‘1st IPC Workshop on Human Vaccines & Immunosera: Regulatory and Quality Considerations’ on December 19, 2018, at IPC Regional Office, Hyderabad. This will help IPC to address the regulatory and quality related challenges in the area of human vaccines and immunosera.
With continuous growth in the pharma industry, India has emerged as one of the leading vaccine manufacturers worldwide. India supplying large quantities of basic and advanced vaccines across the world. Vaccines are very important for global health and they truly help in reducing the prevalence of diseases.
The Central Drug Authority in India (CDSCO) assigned a duty to handle discharging function under the Drugs and Cosmetics Act. CDSCO work is to keep regulatory control over the import of drugs, approval of new drugs and approval of clinical trials. There are certain challenges that still need to be addressed as the human vaccines and immune sera have taken center stage in drug discovery and development with enhanced safety profiles for human use.
The main motive of IPC in organizing this workshop is to address these issues. This workshop is to create awareness about the IP standards among the stakeholders; better knowledge of regulatory pathways for the approval of vaccines in India; conversation on the issues related to post-marketing pharmacovigilance; understand the quality control specifications of Human bacterial and viral vaccines; and provide common platform for regulatory understanding between CDSCO, IPC and industry.
Main audience that will be targeted includes QC Analysts of Manufacturing and Regulatory Labs; R&D Scientists of Manufacturing and Academic Labs; Regulatory Affairs Professionals; Contract Research Organization Scientists & Managers; and Contract Manufacturing Organizations Professionals.
On 1st January 2009 IPCC was created as an autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India. The main basic work of IPC is to update regularly the standards of drugs by publishing the official written standard in the form of Indian Pharmacopoeia (IP). It also provides measurement standards in the form of IPRS which act as a fingerprint for identification of an article under test and its purity as prescribed in IP.
The IP, or any part of it, has got legal status under the Second Schedule of the Drugs & Cosmetics Act, 1940 and Rules 1945 thereunder. IP standards are authoritative in nature and are enforced by the regulatory authorities for the quality control of medicines in India. During quality assurance and at the time of dispute in the court of law the IP standards are legally acceptable
The primary function of IPC is to set standards of drugs in the country with a vision ‘to promote the highest standards of drugs for use in human and animals’ and mission ‘to promote public health in India by bringing out authoritative and officially accepted standard for quality of drugs’.