If the drug you consume is banned in US, UK, Canada, Japan, European Union or Australia, you may need to get a new prescription. The government is streamlining the drug regulatory system to filter drugs with serious side effects, based on their ban status from six major drug regulators globally.
For instance, Analgin, a pain killer, was banned in the US and Sweden in the late 1990s as it triggered a sharp fall in white blood cells, but is still sold in India.
Henceforth, such drugs would not be sold here until clinical data proves them safe. The move was triggered after the government learned about Danish firm Lundbeck’s anti-depression drug Deanxit, which is banned in Denmark but allowed be exported.
“We are looking at developing a higher level mechanism to filter out drugs that have been banned by top drug regulators,” said GN Singh, drug controller general of India (DCGI). “However, the planning is being done by health ministry and we are waiting for a draft from the department.”
DCGI has directed all companies to conduct clinical trials of generic medicines and seek national drug regulatory approval within 18 months.
“Outdated drugs and formulations should be seriously re-looked at to shunt out drugs that trigger serious side-effects,” said Anoop Misra, head of department of diabetes and metabolic diseases, Fortis Hospitals. Some anti-diabetes and anti-obesity drugs were banned years after developed countries did it, he said A health ministry official said over 300 drugs in the Indian market don’t have clinical trial data.
