Clinical Trials In India: Boom To Stasis To Green Shoots?
This article was originally published in PharmAsia News
Executive Summary
It may be too early to celebrate but some execs in the Indian clinical trials industry are hoping for a slow turnaround as rules are streamlined and the sector gradually syncs its operations with the reformed regulatory checklist.
MUMBAI – Regulatory approvals for clinical trials in India for the first three months of the year were down to a trickle compared with 2014, but better processes and faster clearances of bioequivalence studies is keeping up hopes of sunnier days ahead.
The optimism is also being fueled by recent deals predicated on emerging confidence in the clinical trials sector, which has long been battered by court proceedings and regulatory strictures.
In January this year, the Drug Controller General of India (DCGI) allowed only eight clinical trials versus 20 last year; in February 2014 it was 16 as opposed to six this year, and in March, the regulators allowed only one trial against 15 in the same month last year. This lone permission was for late-stage trials with AstraZeneca PLC’s Brilinta (ticagrelor) for acute coronary syndromes and listed a series of compliance parameters.
In total, 2014 saw 150 approvals, with a mix of new drug trials, global clinical programs and some categorized as institutional trials (Also see "Indian Clinical Trial Approvals To Be Based On Risks, Innovation And Need" - Scrip, 9 Sep, 2014.).
Faster Approvals
Although the pace of approvals appears to have taken a big beating this year, top leaders in the clinical trial segment say systems are becoming more amenable to the industry’s practical necessities. One CEO-level executive noted that approximately 40% of approvals for pending bioequivalence studies are expected within a month, while about 70% of BE approvals are granted within six to seven weeks.
“This is a dream when seen against the 2012 and 2013 numbers,” the executive said, citing the example of scores of BE studies that had virtually reached a stasis.
Another industry official credited the improving situation to regular meetings of the Subject Expert Committee that approves clinical trial studies. If documents are in order, he said, the SEC grants permissions within a short period.
That apart, he said prospects in new business areas are likely to bring new hopes. International companies have already made enquiries regarding studies for some top-selling biosimilars and that could up the game in handling sophisticated trial designs.
Green Shoots From Reforms?
These may be the much awaited green shoots to bring confidence back to the sector, against a past gloomy backdrop that saw clinical trials move out of the country at a fast clip, not just by global companies but also local big firms including Sun Pharmaceutical Industries Ltd., Biocon Ltd. and Lupin Ltd.
In the last decade, India ranked as a preferred destination for clinical trials by global drug makers but litigation revolving around patient safety and ensuing strictures from courts led to the drying up of projects. Among the many allegations, activists charged that global companies had conducted trials on gullible patients without adhering to informed consent procedures and that those affected by adverse events were not paid the right compensation.
With an aim to streamline processes, under pressure the DCGI last year followed up with a suite of rules and checklists, primarily on filming the consent processes for clinical trials and issuing detailed guidelines for compensation and benefits to affected patients (Also see "Clinical Trials Approvals Rise In India, But Is It Only In Numbers?" - Scrip, 16 Oct, 2014.).
Sponsors and contract research organizations (CROs) had expressed reservations that videography of patients raised more hurdles than facilitating trials. However, that point was countered by a veteran executive in a medium-sized CRO from Ahmedabad. He conceded that the issues are tricky, but noted an example where a request for waiver of videography by the patient was being considered by the Subject Expert Committee, pre-conditioned on the approval of the Ethics Committee.
Shakeout And A New Start
Attribute it to long stagnation in the industry or a lack of visibility on future upsides, but some CROs have started to sell out. Last year, Karmic Lifesciences divested its entire business to Ahmedabad-based Cliantha Research, a move it said would help build its data management, pharmaceutical analytics and medical marketing practices.
Industry observers said Karmic has struggled to survive the crisis of a shrinking client list and lost direction, forcing it to exit the business.
Last month, two more deals signaled the industry is consolidating. Fortis CRO, an offshoot of one of India’s largest hospital chains, Fortis Hospitals, and owned by the founders of Ranbaxy Laboratories Ltd. Malvinder Singh and Shivinder Singh, sold out to Quest Lifesciences based in Southern India.
According to news reports, Fortis primarily served Ranbaxy for its submissions and approvals but following Ranbaxy’s takeover by Sun Pharma, it became a non-core business for the group. Quest aims to use Fortis to expand its services beyond its Phase I to IV capabilities.
On similar lines, Mumbai-based pharmaceutical firm Indoco Remedies Ltd. recently announced it purchased the entire assets of Piramal CRO. Piramal’s clinical research arm was part of the Piramal Enterprises Ltd. business empire, which dramatically downsized its pharmaceutical business in 2010 by selling its domestic prescriptions business to Abbott Laboratories Inc. Piramal’s clinical research was therefore categorized as non-core by market analysts.
However, the move is also seen by a few as an opportunistic buyout proposition for Indoco Remedies Ltd. Sundeep Bambolkar, joint managing director, said the deal fitted perfectly into Indoco’s immediate requirements for BE studies, as the company has lined up several highly specialized filings to the U.S. and European regulatory agencies.
Bambolkar noted that the BE studies from the Piramal acquisition will cut its dependence on outside agencies and help achieve timelines. He maintained that the company will keep growing its business from Piramal’s external clients but noted it was too early to walk through a detailed strategy.