Posted 11 March 2016
By Zachary Brennan
Dinesh Thakur, the now-famous Ranbaxy whistleblower who won more than $48 million for calling out the company’s drug safety issues to the US Department of Justice, failed on Friday to get the Supreme Court of India to hear two petitions seeking to challenge the law under which India’s drug regulator Central Drugs Standard Control Organization (CDSCO) operates.
Thakur told Focus that the petitions “challenge how CDSCO works and the commitments it makes” to keeping substandard drugs off the market. He also highlighted local issues in prosecuting manufacturers that make substandard drugs.
“Bureaucrats appointed to committees with a mandate to protect public health often relinquish their duties by becoming de-facto spokespersons for the industry as was seen with the Drugs Consultative Committee (DCC) when it came to taking policy decisions on safety issues which would affect the profitability of the industry. Our regulators have sold their soul to the industry and its financial goals,” he wrote Friday on his blog.
He also pointed to a main difference between India’s manufacturers and those in the West, as “there are two quality standards in the Indian industry, one for export-oriented ‘regulated’ markets and a different (read ‘lower’) standard for domestic ‘less regulated’ markets.”
A Focus investigation in November uncovered a number of concerns with regard to Indian manufacturing and data manipulation for products manufactured by FDA-regulated facilities.
Thakur also told Focus that having state regulators is bad for regulation and that there should be one unbiased national regulator funded accordingly.
In September, CDSCO put forth a plan to strengthen state regulators and set up new "systematic collection and testing of sufficient number
of samples in laboratories. The laboratories in States are therefore, required
to be strengthened."
“Making changes to the current regulatory system is very hard; the previous government tried twice, once in 2007 and a second time in 2013. While the amendments in 2007 tried to create a Central Drugs Authority, the amendments in 2013 sought to give the central government the sole power to regulate exports and called for centralised licensing for certain classes of drugs,” Thakur wrote this morning.
Roger Bate, an economist at the American Enterprise Institute who’s written on substandard Indian drugs alongside Thakur, told Focus that the country’s pharmaceutical laws are outdated.
“From my experience, which is now out of date, [the Indian states of] Haryana and Uttar Pradesh were very poorly regulated, which is where a lot of poor manufacturing (and outright fraudulent manufacturing/counterfeiting) occurred. Maharashtra and Andra Pradesh did a better job, but still far from perfect,” he said.
India's Supreme Court, headed by Chief Justice T S Thakur, which heard the petitions Friday, questioned Thakur, according to the Business Standard. “An overseas citizen has to come all the way to challenge a rule. What is your locus?” the chief justice asked.
"You are coming with academic issues when people are languishing in jails. Our hands are full,” he added. The bench dismissed the petitions as withdrawn.