Quickening interest among the domestic companies managing drug safety data was Parexel International’s announcement to buy Quantum Solutions India in March.

The Boston-based CRO said the company would integrate the Indian pharmacovigilance services firm into its post-approval services, expecting to close the buy-out the following month.  

Located in Chandigarh, in the northern part of India, the privately-owned QSI offers services including individual case safety report processing, brand physician activities, affiliate support, aggregate report writing, literature reviews and signal detection for clientele across pharmaceutical, medical device and consumer products.

The acquisition of QSI would enable Parexel to provide a more comprehensive, efficient and economical solution to clients around the world, the companies chief executive stated in a news release.

Though Parexel did not reveal the financial details of the deal, the news of the acquisition infused a shot of enthusiam into the pharmacovigilance services arena, which has seldom grabbed headlines over the years.

Spurred by increasing requirements for drug surveillance data by regulators, the drug safety data outsourcing market is gaining pace world over. Currently estimated around $2 billion, the nascent sector is forecast to double its size over the next five years, according to Transparency Market Research.

Roadmap In Works
In India, companies providing drug safety monitoring have witnessed impressive growth over the last several years. Leading players in the field such as Accenture, Cognizant Technology Solutions and Tata Consultancy Services are managing extensive pharmacovigilance operations in the country. More than 14,000 people are presently working in this sector, which marks a huge leap from a few hundred 7-8 years ago.

Quite a few drug makers, including members from Big Pharma, are offshoring drug safety data to these Indian firms, making use of the cost advantage factor. India’s genetically diverse population base could also be an enabler to facilitate faster assessment of drugs’ adverse impacts.

In sync with the tightly regulated markets, India has already started working on a roadmap for bolstering the country’s pharmacovigilance regulatory system.

The existing law requires that manufacturers submit periodic safety update reports to the regulator for the first four years after a new drug is introduced into the market.

The companies should list out adverse reactions, drug-related injuries and fatalities post-marketing in Indian patients every six months in the first two years. For the remaining two years companies need to report once a year. Companies don’t have to submit any more reports to the Central Drugs Standard Control Organization—the top drug regulator’s office—after this four-year period. The drug will, thereafter, be monitored under national surveillance registry known as Pharmacovigilance Programme of India (PvPI).

A large number of manufacturers, however, were not eager to fulfill this requirement of updating CDSCO with periodic safety reports, despite being listed as mandatory in the rule book.

The Drug Control General of India (DCGI) recently, initiating the efforts to streamline the drug safety monitoring mechanism, made the decision to link the periodic safety updates submitted by the companies to PvPI.

Started in 2010, PvPI collects spontaneous adverse drug reports (ADRs) from the ADR monitoring centers across the country. After collating and analyzing the adverse events data, it computes the risk-benefit ratio and recommends regulatory interventions, if required.

The regulator hopes such a linking would enable better and more efficient monitoring of the drugs from the beginning by enhancing PvPI as a central point to integrate and store all the data on the possible adverse drug reports. The process for intimating drug makers to send their periodic safety updates to PVPI has started, reports state.

At the same time, the authority is moving to make drug surveillance cells compulsory for pharma companies. Even though firms are required to submit post-marketing drug safety updates on newly introduced drugs, the specific clause in the regulation has not been insisting to have their own drug safety monitoring system in place.

India’s Drug Technical Advisory Board, a high-power experts committee which advises DCGI on technical matters, recommended that firms should start the practice of reporting adverse events of marketed drugs to the regulator by establishing vigilance cells under the supervision of a medical officer or a pharmacist trained in this discipline. The facility would collect data, process them and forward the adverse reaction reports to the regulator.