In May of this year the DCGI issued guidelines to report Serious Adverse Events in India (SAEs), the aim of these guidelines is to standardize and mainstream SAE reporting in this country. Conversely to the FDA, there is no 1571 when submitting an addendum or amendment to the DCGI and therefore, one of the first steps to mainstream SAE reporting was to set up a coversheet to be enclosed with the SAE form to be submitted to the agency. The cover sheet includes standard information related to the study, Clinical trial file number at the DCGI, the sponsor and CRO contact information, the investigational product and investigative site information. Additionally, information related to the SAE, adverse event term, expected or not expected; its causality per investigator and medical monitor assessment, plus a brief narrative. The DCGI also added a box related to the clinical trial category and provided a list of 8 categories to choose from (these range from new entities developed in India, to global clinical trials, various types of biological products, devices etc). The detailed listed is provided within the guidelines document.
Finally, sponsor or their representatives in India (CROs), have to complete an SAE reporting form: “Suspected Adverse Drug Reaction Reporting Form” to be submitted with the cover letter described above and any supportive documentation (laboratory results, discharge summaries, autopsy reports). At this time, CIOMs and/or MedWatch for the same SAE can be included with this SAE reporting form and cover letter, however, the documentation has to be consistent.
The Indian agency has launched a Pharmacovigilance Programme of India for Assuring Drug Safety, the aim of the program over the next 5 years is to ensure that the benefits of use of medicine outweighs the risks and thus safeguard the health of the Indian population and has for key objectives:
- To monitor Adverse Drug Reactions (ADRs) in Indian population
- To create awareness amongst health care professionals about the importance of ADR reporting in India
- To monitor benefit-risk profile of medicines
- Generate independent, evidence based recommendations on the safety of medicines
- Support the CDSCO for formulating safety related regulatory decisions for medicines
- Communicate findings with all key stakeholders
- Create a national centre of excellence at par with global drug safety monitoring standards
The Pharmacovigilance Program of India will be administered and monitored by two committees, a Steering Committee and a Strategic Advisory Committee. The Steering committee includes as chairman Drugs Controller General (India), New Delhi, ex- officio and members from various institutions such as the Pharmacopoeia Commission of India, representatives from the Ministry of Health & Family Welfare, Directorate General Health Services etc.
*CDSCO or Central Drugs Standard Control Organization