Ranbaxy Whistle-Blower Is back; Takes Indian Regulator To Court
This article was originally published in Scrip
Ranbaxy whistle-blower Dinesh Thakur has fired a fresh salvo - this time taking the Indian drugs regulator to court for alleged lax enforcement of rules concerning the safety of medicines in the country.
While the case is expected to come up for admission on March 11, analysts appeared jittery about the potential "paralysing" effect such cases could have on the Indian industry – akin to what happened in the clinical trials segment – while also derailing the regulatory reform process underway in the country. There were also some murmurs of the whistle-blower acting on behalf of those with vested interests.
Thakur, who has in the past emphasised that relying on inspectors from a foreign regulator like the US FDA to enforce quality standards in a different country is not feasible in the long run, is said to have moved court against India's health ministry and the Central Drugs Standard Control Organization (CDSCO), among others.
Details on the website of the Supreme Court of India say that the case is "likely to be listed" on March 11.
Reuters said that the suit "sets as objectives" the creation of a framework for the recall of drugs and a commission to examine faulty drug approvals. Thakur, the agency report notes, is said to have referred to, among others, how an "overwhelming" number of non-standard-quality drugs are not prosecuted in criminal cases, since Indian state drug controllers only impose "minor administrative penalties" on the offenders.
Thakur told Scrip that the admissions hearing is on Friday and hence he would be unable to share the petitions ahead of time.
Thakur, a former Ranbaxy director and global head, research information and portfolio management, who helped the US FDA and Department of Justice unravel a complicated trail of falsified records and manufacturing practices that violated GMP norms at the company, is also said to have noted how Indian authorities did not approach him post the Ranbaxy case or inquire the reasons for the fine nor responded to him through 2014.
Top CDSCO officials could not immediately be reached for a comment.
In 2013, Ranbaxy, now part of Sun Pharmaceutical Industries, pleaded guilty and agreed to pay $500m to settle felony charges of manufacturing and distributing adulterated drugs made at the company's Paonta Sahib and Dewas facilities in India.
Thakur had, in an earlier interaction with Scrip, referred to fraud documented by regulators like the US FDA and MHRA at companies located in India and China and underscored that national regulators need to play a much more "proactive and authoritative" role in ensuring quality and consistency of medicines in these markets.
"Given the level of dysfunction and incompetence of the regulatory framework and the regulators, governments in these countries need to fund and find appropriately qualified public health professionals to run these organizations," Thakur then said.
He also then urged the pharmaceutical industry to monitor its supply chain for "economically driven adulteration", especially from sourcing ingredients to manufacturing the product.
Reacting to the new case, Dilip Shah, secretary general of the Indian Pharmaceutical Alliance, which represents leading domestic firms, told Scrip that the industry "welcomes all attempts to improve India's drug regulatory regime."