4 Jan 2013

Supreme Court Asked Indian Government To Monitor And Regulate All Clinical Trials Of Experimental Drugs In India

Pharmaceuticals are both boon and bane depending upon its use and misuse. For instance, clinical trials of experimental drugs in India is going more on the side of a bane that is emerging as a potential threat and havoc to human lives in India.

So much so that the Supreme Court of India has directed Health Ministry of India to monitor and regulate all clinical trials of experimental drugs in the country until further notice. The Court has also showed its unhappiness with the growing use of clinical trials of experimental drugs in India without much monitoring and said that this scenario has caused “havoc”.

Supreme Court did not stop here and it revoked the power of the Central Drugs Standard Control Organisation (CDSCO) under the Drugs Controller General of India (DCGI) in this regard as well. CDSCO has been the apex agency for monitoring clinical trials in India so far.

The Court has also directed the health secretary to file an admissible affidavit within four weeks after it refused to accept one filed by deputy drugs controller. The Court refused to admit such affidavit because in October the Court made its intentions clear that it may bar clinical trials in India unless the Health Ministry provides information within a month regarding deaths during such programmes. The Court also sought explanation regarding compensation and general practices when new drugs are tested on Indians.

Surprisingly, no laws were in place between 2005 and 2012 for new chemical entities and yet the government was approving trials very casually. If this is not enough, illegal and unregulated online sales of prescribed medicines in India are happening right under the nose of Indian Government. Online pharmacies in India are violating Indian laws and Indian Government is least interested in curbing this practice.

We have weak health related laws in India, including those pertaining to online sales of prescribed medicines in India. We have no dedicated data protection laws in India and privacy laws in India. Even data exclusivity laws in India need to be formulated. A regulatory framework for data exclusivity In India can be really helpful in this regard.