The Indian Society for Clinical Research (ISCR) now sees the need for pharma companies to be engaged in the Pharmacovigilance Programme of India (PvPI) to promote patient safety.

Adverse drug monitoring improves patient care, public health and provides a risk benefit assessment of medicine. It is also an effective mode of communication to the health professionals and the public, said Indu Nambiar, co-chair, Pharmacovigilance Council of ISCR and Senior Manager-Local Pharmacovigilance, Boehringer Ingelheim, India.

The developed countries like US and UK are known to report higher ADR than India. Increasing efforts to ensure serious adverse events (SAE) reporting from sponsor, investigator, and ethics committee are needed, she said at a panel discussion on Strengthening Pharmacovigilance for a Healthy India at the 67th IPC in Mysuru recently.

For the future, India will need to devise specific national current reporting rate graphics. In addition, an updated online platform where doctors can view the current adverse reporting rates with the product in context along with pivotal trial rates as per EMA Eudr Vigilance would create a better knowledge about the drugs, she noted.

Every pharma industry will need to chip in support services for the strengthening of PvPI. There is need to embark on field work, put up safety posters, create a core committee on safety monitoring and have a Risk Management Forum. With the access to advances systems like iPad reporting an adverse drug reaction event is faster and easier, she said.

The areas affecting pharmacovigilance are the presence of large population predominant in rural areas, use of traditional medicines, lack of physician and consumer awareness program, besides time factor, misconceptions on legal implications and missing regulatory mandates for the stakeholders.

In order to improve the effectiveness, there is a need for the pharma industry, healthcare providers and the pharmacists to come together as a team to enable targeting the core of the reporting system. For this, India will need to encourage contributions to the safety data by stakeholders for real world safety, develop risk management plan and bring in transparency in communication. There is need for engagement to match the right patient to the right drug. Over the years we have made drugs safe for people. Now we need to make people safe for drugs. Therefore India needs a robust pharmacovigilance system to provide updated information with the guidelines that inculcate efficient and transparent reporting culture, said Nambiar.

Delving on the ISCR and PvPI journey so far, she said that interactions with Indian Pharmacopoeia Commission on office order pertaining to ADR reporting to PvPI was attended by CDSCO officials and this involvement could shape the future to highlight SAEs.

“All of us cannot become doctors. But all of us can become patients. Even doctors can become patients, therefore ISCR sees need to engage pharmaceutical industries in PvPI to promote patient safety”, she said.