Earlier this month, India's Supreme Court bemoaned that unregulated clinical trials were "causing havoc" in the country, demanding that the Central Drugs Standard Control Organization explain how it intends to fix the situation. Now the regulator has until the end of this month to come up with some answers, Outsourcing-Pharma reports.
On Jan. 3, the Supreme Court ordered the Health Ministry to monitor new applications for clinical trials in the country, chiding the CDSCO for not doing enough to protect Indian citizens, who are often enrolled in studies against their will and denied compensation after adverse events.
But despite its demand of a new affidavit from the CDSCO, the Supreme Court has not specified how or when it would like to see India reform its regulations. Not only are India's current trial regulations vague; figuring out just who can alter and enforce them has been just as vexing.
Under Indian law, there are no minimum clinical standards for trials, so any physician can conduct a legal trial at any private clinic, and doctors convicted of holding secret trials are often fined less than $100. Officials and humanitarians have been up in arms of late, warning that some CROs and pharmas exploit loopholes in the law and endanger the country's poorest residents.
And, in business terms, many in the Indian government warn that the constant stream of press on the country's trials might scare potential partners away to up-and-coming markets like Taiwan and South Korea.
However, some Indian CROs and drugmakers say strengthening regulations will just increase the cost of doing business in the country, eventually pricing out local companies and making the country's clinical research market affordable only for multinational corporations.