The Supreme Court on Monday relaxed its earlier stand on clinical trials of new drugs and chemical entities on humans but insisted on strict regulations being in place before approval of any tests.
Of 162 chemicals under scrutiny, the court was informed by the government counsel that five had been cleared by the new drug advisory committee. These and the remaining 157 will have to be reviewed by two other panels. The Drug Advisory Consultative Committee and its apex body have to examine the trials even if the advisory committee has approved of these. The government assured the bench headed by judge R M Lodha that the procedure would be strictly followed.
On September 30, the SC had directed the Union health ministry to stop all trials till a safety mechanism was in place to properly monitor these. The order sent shock waves in the drug industry; it had also put on hold several projects involving foreign pharmaceutical entities.
These directions were given on a batch of public interest petitions, led by a Swasthiya Adhikar Manch, Indore. These had been moved after a clinical test scam in that city, where several doctors and hospitals were accused of conducting trials on patients without their knowledge or consent. The next hearing in the case will be on December 16.
On Monday, as mentioned earlier, the SC appeared to relax the curb, with some tough conditions. While approving the tests, the authorities shall balance the risks and benefits. Innovation vis-a-vis the existing options are to taken into account. Need for the chemical tested should be assessed before granting approval. The judges also had a query on how many of the chemicals proposed to be tested had been patented abroad and whether these would help this country.
The judges clarified they were not against tests being conducted but wanted a foolproof regulatory regime, quarantined from extraneous considerations. Private investigators were not likely to be independent; there should be experts paid for by the government, they said. The additional solicitor general assured them that government experts were on the committees.
