Ranbaxy Whistleblower Petitions PMO To Investigate 'Illegal' Drug Approvals

Ranbaxy Whistleblower Petitions PMO To Investigate 'Illegal' Drug Approvals

NEW DELHI, 21 MAY 2018: Ranbaxy whistleblower Dinesh Thakur has petitioned the Prime Minister’s Office, seeking a commission to investigate the manner in which several potentially irrational medicines have been approved and marketed in India.


The move follows lack of action by the health ministry on its commitments to a parliamentary standing committee to resolve issues flagged with approvals of four drugs for specific indications without scientific evidence, according to him.


The Drug Controller General of India, the country’s apex drug regulator, has in the past approved medicines for treating certain diseases “despite an absence of any clinical data to justify these approvals”, Thakur stated in his petition dated May 7, a copy of which was viewed by ET.


Thakur has asked the PMO to direct the appointment of a commission of inquiry to investigate the manner in which DCGI and state authorities have granted “so many illegal approvals”. He has also asked PMO to direct Niti Aayog to propose a new law to replace the Drugs & Cosmetics Act, 1940, alleging the current framework is “ineffective” to support the Prime Minister’s vision of Ayushman Bharat.


Regulators today lack the “appropriate tools” to penalise pharmaceutical companies for violating the law, he claimed. An email sent to the PMO about the petition remained unanswered till press-time on Sunday.


Thakur has specifically highlighted DCGI’s approvals to buclizine, letrozole and fixed dose combination drugs flupentixol + melitracen and aceclofenac + drotaverine for treatment of specific conditions that he alleges were granted without proper clinical evidence.


The Parliamentary Standing Committee on Health and Family Welfare had flagged these drugs in its 59th and 66th reports over such concerns as well. “When written commitments to Parliament to conduct investigations are not being honoured and when the government regularly loses legal proceedings before the courts, it is clear that the problem is systemic and deep rooted and can be fixed only by the intervention of the PMO,” Thakur said in his petition.


For instance, the parliamentary committee in its 59th report criticised the health ministry over its clinical trial approvals to the aceclofenac+drotaverine combination, indicated for abdominal pain, stating that the drug was not approved “in any developed country”. The committee stated that there was sufficient evidence on record to conclude that there was a “collusive nexus” between drug manufacturers, medical experts and some functionaries of the Indian drug regulatory body. ET Healthworld