New Delhi: Almost two months after a Parliament Standing Committee raised an alarm on untested drugs, it has been found that they are still being freely sold in the market. The shocking findings of the Parliament committee had put a huge question mark on the credibility of the Central Drug Standard Control Organisation, highlighting loopholes in drug safety laws.
According to its report, 33 new drugs were approved by the drug controller agency between January 2008 and October 2010 without mandatory clinical trials on Indian patients in the name of public interest.
The drugs included Daptomycin of Novartis, an anti-biotic used to treat skin infections; Alimta of Eli Lilly, a chemotherapy drug meant for cancer treatment; Isentress of Merk Sharp and Dhome used to treat HIV patients.
And since none of these are emergency drugs, there was no need for the drug controller to exempt them from clinical trials. What's worse is that almost two months after the information came to light, the drugs have still not been withdrawn from the market.
Sources say that the Health Ministry has constituted a 3-member committee to probe allegations made in the standing committee report. However, it is unwilling to withdraw the drugs, allegedly fearing a backlash by Pharma companies.
Also, the drug controller's office does not have any post-marketing surveillance data, which is required to collect in cases where drugs are approved without mandatory trials.
The Parliament Standing Committee's report had even hinted at an alleged nexus between the drug controller's office, Pharma companies and doctors.
The government's inaction now seems to suggest that there's more than meets the eye.