At a time when drug recalls are becoming the order of the day, the spotlight falls increasingly on the safety of medicines sold in the marketplace. Post-marketing surveillance practices, to assess the safety profiles of drugs that have already passed stringent regulatory scrutiny, have not always been a priority for many. Drugmakers tend to shy away from the resource-intensive pharmacovigilance (PV) activities.

But with regulators in critical markets beginning to look more closely at the post-marketing data of approved products, the drug firms find no other way out but to embrace PV. This circumstance has led to a spurt in need for PV services, throwing open a huge window of opportunity for outsourcing.

Dr. Shirish Sherlekar, global head, Lifesciences Practice, Tata Consultancy Services Life, remarked, “Suddenly the demand from MNCs has grown. We are getting five or six inquiries for drug safety studies today compared to two or three such queries as little as a year ago. Not only the big pharma but companies holding smaller portfolios of only two or three molecules also are looking out to the third-party vendors to reduce their workload.” Dr. Sherlekar’s firm is a leading BPO services provider from India.

Generation and assessment of adverse drug data involve a spectrum of activities that a firm may be unable to handle on its own. Captive PV centers warrant skilled individuals ranging from trained nurses to specialized doctors to probe through case reports and review reams of data. 

MNC-Generic Tie-Ups Spur Demand

Outsourcing comes in handy in this case, as there are very many providers out there specializing in different aspects of PV processes. Providers, which include CROs involved in drug development research and BPOs proficient in this field, can help cut down on costs considerably, compared to in-house operations.

“Initially, pharma companies used to be a bit hesitant to outsource PV processes to the third party, as they were unsure of the accuracy of the outsourced data and the expertise of the service providers in this field,” said Dr. Chitra Lele, chief scientific officer with Sciformix, a global service provider for life science companies specialized in biometrics, scientific writing, safety and risk management and regulatory affairs.

Interest in the relatively new field of PV outsourcing has been on the rise. The scene has further brightened up with the ongoing trend of generic companies tying up with MNCs. Several multinationals have made alliances with Indian generic makers and a certain amount of PV studies are mandatory on the sourced generics as part of these deals. India-based PV providers can see a significant upside potential since they can offer the services at a cost that is almost 50% lower than anywhere else, according to her.

Cost arbitrage is an important factor but it is not always the most important when it comes to safety data generation, where the capability and compliance of the providers matter more. Even though Indian CROs have the relevant domain knowledge and other IT-oriented BPOs have gained considerable expertise, they need to mature to meet the required level of compliance.

In India, post-marketing surveillance is not yet a widely adopted practice, and its outsourcing industry is juvenile. Notwithstanding, Indian firms have developed PV skills much faster, especially in the basic knowledge domain, say experts in the field.

Need For Managing Gaps

“Along the range of PV processes, few Indian companies have achieved good expertise in the area of processing of single case reports,” remarked Dr. Sherlekar. Being upstarts in the field, most of the players are currently in the mid-stage of their evolutionary process of achieving competencies in preparation of aggregate safety reports or measuring their impact on the labeling and data sheets of the product. Several of the service providers are developing but have yet to perfect their skills in areas such as signal detection.

Very few BPOs/CROs qualify for the capability and compliance level required for the job in the fledgling industry. TCS has the early mover advantage being the first Indian company to forge a drug safety outsourcing alliance with an MNC. The company has started on single case safety reports right from the year 2006. Blending medical domain knowledge with its IT edge, Six Sigma practices and other quality parameters, TCS will deliver aggregate medical reports as well. Its BPO center in Budapest, Hungary has been granted approval following auditing by FDA for compliance norms, Dr. Sherlekar noted.

Apparently, the outlook is “extremely bright” for Indian providers. However, the dearth of professionals, specifically trained to suit the requirement, remains a hurdle for PV firms. In spite of a huge skill base, the challenge will be to manage the gap between the required number of people and their availability. 

S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at [email protected].