Updated on 10 January 2013
Order not a setback
"There is no need for us to make a knee-jerk reaction to the apex court order. It is time for us to take a step back and analyze the situation and assess what all the stakeholders in the clinical trials industry need to do in this situation," says Mr Ranjit Shahani, vice chairman and MD, Novartis India. "There is a need for clear communication about issues, such as compensation, to be discussed by the government."
Many in the industry are of the opinion that this is a blow to the $600 million (Rs 3,246 crore) bioservices industry in India, since it will only add to delays in other projects as well. However, at a recent annual conference on clinical research organized by the Indian Society for Clinical Research (ISCR), industry experts opined that the court order should not be taken as a setback, but rather as a measure to keep spurious practices at bay.
"The court order does not dis-empower clinical research organizations (CROs) in India and should not make a major difference. It only asks for the previous directives to be followed. This includes furnishing details in different cases, such as one where the relevant states are being asked to submit all the data surrounding the clinical trials, for the Supreme Court to study," says Ms Suneela Thatte, executive director, customer operations, Quintiles.
Dr Krathish Bopanna, chief executive officer, Semler Research Centre and president, ISCR, agrees. "The order should not affect any legitimate CROs in India, as it only asks for the reinforcement of existing rules. It is directed towards outfits that are like fly by night operators who have been indulging in malpractices that are in the news," says Dr Bopanna.
In another instance, on January 8, 2013, the Supreme Court responded to a PIL filed against vaccine majors Merck and GlaxoSmithKline (GSK) for allegedly conducting clinical trials on nearly 24,000 tribal girls in Andhra Pradesh and Gujarat even before the vaccine was licensed by the DCGI. The Supreme Court has not only directed the Union Government to respond to the allegation, but also asked Christian Medical College, Vellore, to analyze the medical reports of the girls who allegedly succumbed during the trials.