Only a few Indian pharmaceutical companies comply with Central Drugs Standard Control Organization (CDSCO) regulation to submit Periodic Safety Update Reports (PSURs) on a regular basis, according to Dr J Vijay Venkatraman, MD & CEO, Oviya MedSafe. Other companies show a tepid response due to an alleged CDSCO delay in acknowledging their submitted reports. However, manpower shortfall at the CDSCO could be a reason for this delay.

Post-marketing pharmacovigilance can result in meaningful patient safety advantages only if CDSCO and pharmaceutical industry collaborate constructively, Dr Venkatraman told Pharmabiz.

Since the 2005 Schedule Y amendment, PSURs submission is almost the only post-marketing drug safety obligation for Marketing Authorization Holders (MAHs) in India. This regulation was re-emphasised by a CDSCO order dated August 28, 2012 and structured as per clause 4, sub clause (v) of Schedule Y of the Drugs and Cosmetics Rules. It mandated PSURs of all new drugs to be submitted to the Drugs Controller General of India (DCGI) every six months for the first two years and annually for the next two years.

“Definitive responses from the CDSCO after thorough review of the submitted PSURs would strengthen Indian pharmacovigilance. While this is just one side of the coin, it is also a bitter fact that MAHs tend to view any investment for compliance as a burden. Pharmacovigilance departments within the Indian pharma industry find fund allocation approvals difficult for drug safety related tasks. Hence, it is important to reflect on factors that make our drug safety system complacent and work to rise above them,” he adds.

Pharmacovigilance Programme of India (PvPI) which collects suspected adverse reactions from healthcare professionals and consumers for analysis and entry into Uppsala Monitoring Centre’s database is not fully integrated with the CDSCO. This has led to a significant amount of information going unnoticed, thereby resulting in a less informed decision made on the drug safety profile. It will be worthwhile for the industry and the regulator alike, to harness the expertise of the 8-year old full-fledged global pharmacovigilance outsourcing industry in India to bridge the gap in assessing drug safety, pointed out Dr Venkatraman.

“Once this milestone is achieved, our next goal should be to keep pace with the global standards. For that, India needs to formulate standard guidelines similar to European Medicines Agency’s Good Pharmacovigilance Practices to ensure patient safety. Although, the PvPI has made certain positive strides to improve the reporting rate of suspected adverse drug reactions, there is an immediate need for a purposeful regulatory action following the collection of drug safety data. Further, pharmacovigilance requirements such as literature monitoring, risk management plans, signal detection and concept of a Qualified Person for Pharmacovigilance (QPPV) may be adopted from the European Union, considering that India is currently a pharmaceutical production hub”, he says.

“With emerging regulatory agencies from MENA (Middle East and North Africa) region adopting the European system of pharmacovigilance, India needs to gear up to legislate and implement robust drug safety norms. It needs to integrate the pharmacovigilance expertise of various stakeholders and devise a multi-disciplinary approach to establish a sound drug safety ecosystem. The capacity-building for this mammoth task can be easily and quickly achieved by tapping the potential of the global pharmacovigilance outsourcing industry in India, which is capable of professionally supporting both the CDSCO and the pharmaceutical industry” he says.