Friday, January 4, 2013

Pharmaceuticals Trials, Experiments And Online Sales Must Be Regulated In India

Recently, the Supreme Court of India asked the Indian government to monitor and regulate all clinical trials of experimental drugs in India.  The Apex Court was anguished over the manner in which clinical trials of experimental drugs in India are handled by Indian government and its departments.

In particular, the Apex Court was angry with the Central Drugs Standard Control Organisation (CDSCO) that has failed to perform its duty properly. So much so that the Apex Court revoked the power of the CDSCO for its failure to monitor and regulate clinical trails of experimental pharmaceuticals in India.

Meanwhile, the government is considering the report of an expert committee set up to examine the issue of alleged approval of drugs without clinical trial by CDSCO. The Department related Parliamentary Standing Committee in its Report on the functioning of CDSCO has raised various issues pertaining to functioning of the organisation, including alleged approval of drugs without clinical trials.

In the proceeding before the Apex Court it came to the light that no laws were in place between 2005 and 2012 for new chemical entities and yet the government was approving trials very casually.

However, till now none have raised any objection regarding the illegal and unregulated online sales of prescribed medicines in India that is happening right under the nose of Indian Government. Such sale of prescribed medicines by e-commerce portals that also without following the laws of the land is really perilious for the end consumers. Online pharmacies in India are violating Indian laws and Indian government is least interested in curbing this practice.

The problem is aggravated in the absence of strong and effective 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.

The health ministry of India in general and the Indian government in particular must take immediate action regarding these situations otherwise serious ramifications may occur.