The Union government came under sharp flaks from Supreme Court on Thursday for being negligent in monitoring and regulating clinical trials.

The Supreme Court was hearing a PIL by NGO Swasthya Adhikar Manch alleging rampant illegal and unethical clinical trials on adults, children and even mentally ill persons in the country.

Taking note the recent report by a Parliamentary committee, which had pointed out that poor and illiterate citizens, including children, were being used in India as guinea pigs by MNC drug manufacturers, a bench headed by Justice R M Lodha observed that it could not allow such trials under the supervision of the Central Drugs Standard Control Organisation (CDSCO) or any other authority which had failed to ensure compliance of rules.

With Additional Solicitor General Siddharth Luthra pointing to the draft rules framed by the government in March 2011, Justice Lodha stressed that a draft rule had no meaning and it had not been framed after the report was tabled by the Parliamentary panel in 2012.

“The drug trials are creating havoc in the country,” the court said, adding that all clinical trials will be done under the supervision of the Union health secretary. “You have to protect the health of the citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stopped,” the bench said and directed the Centre to “handle the menace” in an effective manner.