Clinical Research : Rule offenders may land in Jail soon.

The Department  of Health  and Family  welfare   proposes   to introduce   the Drugs and   Cosmetics  ( Amendment ) Bill  ,2015 in the coming    Budget  Session  of the Parliament.
The bill is now on public domain and invites  comments   and views from the stakeholders before 12 th January 2015.

The bill has the provision of   3 year Imprisonment and 5 lakh fine  for Rule Breakers .
The repeat   offenders   will get maximum 5 years imprisonment and get fine less than 15 lakh.

The Bill has a special Chapter ( I A)  for Clinical  Trials .

The section 4 A says "  No  person, Sponsor ,Clinical research  organisations  or   any  other  organisation  or   investigator  ,shall  conduct  any  clinical  trial   in respect   of a  new drug  ,Investigational new drug ,notified category  of new  medical  device  and  investigational  new  medical device  ,new cosmetic , bioavailability   or bioequivalence    study  of  any  new drug  ,in  human  participants  except under , and  in  accordance   with  , the  permission   granted   by  the  Central  Licensing  Authority  in   such   and  manner  as  may be  prescribed "

Sub-section 2 says "   No  Person   shall  initiate   or conduct  any  clinical   trial  unless   it is   approved   by the  Ethics Committee  constituted   under   section   4 E   in such  manner   as  may be  prescribed "

The sub-section 4 K , 4 L, 4M,4N,4O, 4P, 4Q, 4R deals with the punishment and penalty.

Sub-Section 4K ( i) says:  Any new drug  or Investigational drug , in  contravention   of section   4A  and  the rules   made  thereunder  , shall be   punishable     with   imprisonment   which   may  extend   to three   years  or  fine  which   may  extend to  five  lakh  or both .

Sub-Section 4 K (ii) says : " Any  notified   category   of  new   medical    device  and  investigational    new   medical   device  , in   contravention of  section  4A  and  the rules    made  thereunder , shall    be   punishable   with   imprisonment  which    may  extend  to  two   years  of  fine  of  there  lakh rupees or both."

Who will get punishment ?

Sub section  4 M   says : Whoever,  himself or  by  any  other   person   on his   behalf  , conducts   clinical  trials  with  cosmetic  in   contravention   of  section   4 A  shall be  punishable  with  imprisonment   for  a term  which   may  extend   to one  year  of fine  which   shall   not be  less  than  two  lakh  rupees.

Here,  legal liability goes  to  Sponsor, Contract Organisations  ( CRO) ,Principal Investigator , Clinical Research Coordinators, Trial Manager...
Every body who involved in the Research Process may  be in the receiving ends.
Clinical Research has a great Social Purpose.
Strict Rules and regulations are need .
However, it should be conductive for research.
The People who are making fraud intentionally should be punished.
The People  who are making mistakes by inadvertently should be protected.
Thousands of lives are being saved by the Clinical Research and it new drugs.
Ultimately, Research   means for rewards ,not for punishments.


5-Jan-2015.