India Faces Shocking Lapse in Drug Safety Norms

Bangalore: The number of unapproved medicines is increasing in our country. Surprisingly doctors are taking initiatives to get approval for these medicines even without any necessary clinical trials. A Parliamentary panel exposed the serious slip from the government body. There has already been an allegory that ‘hidden hands’ are behind the approval of medicines by drug regulatory authority.

The report inspected more than 40 drugs. Three of the drugs were seen to be without any available data. 29 percent of the drugs had not gone through the Phase III clinical trials in India. The 10 percent that got proper approval show that the clinical trials were not sufficient in their approval. 33 percent of these medicines are not authorized to sale in countries like U.S., Canada, UK and Australia.

Drug expert CM Gulati said "All of them are compromised. We've got the evidence from the committee that doctors have written identical letters, three doctors have written a letter to the Director General of India requesting to violate the laws and approve a particular drug without clinical trial," as reported by IBN live.

Doctors of famous institutes like AIMS, CMC Vellore and PGI Chandigarh were included in the report. It is really an unfortunate fact that doctors are at the front in promoting these medicines. In defense to the revelation in the report AIIMS Spokesperson YK Gupta said, "Doctors have done so in their individual capacities, this is not the opinion of AIIMS."

PGI Chandigarh strongly responded to the report "We stand by the advice given in response to the query. Doing repetitive trials of internationally marketed drugs released world over is not routinely justified unless there exists some solid ground of differences."