Updated on 21 January 2013
DCGI's January 15 directive is an extension of this case. Based on the Deanxit example, the regulator has asked manufacturers and marketers of all FDCs to submit safety data within 18 months. Analysts estimate that there are more than 300 drugs which have got into the Indian market in the last two decades without generating any clinical trial data.
An Indian Parliamentary committee, which studied the issue in mid-2012, had highlighted the loopholes that exist in the drug regulatory system allowed the proliferation of dangerous drugs that are banned abroad but are being freely made available in the country.
In 2007, the national drug regulator banned 294 drugs that got into the country through the state-level licensing route without safety and efficacy reports. However, these drugs continue to be sold to patients, based on a stay order issued by the regional High Court of Tamil Nadu, India.
Until this case is disposed off by the court, the 294 "banned" drugs will continue to flood the markets. In further tightening of the rules, the national regulator has instructed that any new drug can be licensed by state-level agencies only after the approval of DCGI is obtained. Analysts welcome this move, which seeks to enhance patient safety and crack down on manufacture of substandard and unsafe drugs in the country.