Authorities unlawfully approve banned drugs, go scot-free

                        People of this country, even babies, are being given drugs banned in other parts of the world. The health ministry and regulatory authority responsible for ensuring the safety and efficacy of medicines sold here continue to dither over banning these drugs despite a parliamentary committee specifically recommending an immediate ban on such drugs.

                    No action has been taken against officials in the regulatory authority, Central Drug Standards Control Organization (CDSCO), who gave unlawful approval for these drugs to be marketed in India despite parliamentary committee seeking immediate action against them.




                 In its action taken report (ATR), on the recommendations of the parliamentary committee made in May last year, the health ministry seems to speak with a forked tongue.




                 In the ATR the ministry stated that it had decided to suspend marketing approval of all drugs prohibited for sale in the US, UK, EU, Australia, Japan and Canada for safety reasons but has not banned a single such drug since May 2012. The department-related parliamentary standing committee on health and family welfare has made specific references to several drugs which were either banned for adverse reactions or were being used in India for treatments for which they were not given approval.

                     For instance, the committee referred to the unlawful approval of Buclizine, a drug of no public health importance to India and which was being given to babies and children. This anti-allergic drug was approved in June 2006 for appetite stimulation without clinical trials and without consulting experts for use in children. This was done despite the fact that the company producing the medicine itself states that "because of lack of approved clinical studies and scientific data", Buclizine was not meant for appetite stimulation.

                       Even in Belgium, the originator country of Buclizine, it is not approved for appetite stimulation. Drugs and Cosmetic Rule 30-B bans the import and marketing of any drug the use of which is prohibited in the country of origin. The committee has sought action against officials in the CDSCO who approved Buclizine to be marketed for appetite stimulation in gross violation of the rules. Instead, the health ministry states that the DCGI will constitute an enquiry committee to look into the matter, a move the committee calls "dilatory tactics being adopted by the Ministry to somehow delay action against the wrongdoers".

                      Similarly, another medicine, Deanxit, an anti-depressant, was approved in 1998 flouting several rules. Deanxit is a combination of two drugs one of which has never been approved in India, plus, all combinations are treated as new drugs and can be used only after the necessary clinical trials. However, Deanxit seems to have no import permission and no document showing any clinical trials. Moreover, Deanxit was and continues to be prohibited for sale and use in Denmark, its country of origin.

                      And, Drugs and Cosmetic Rule 30-B bans the import and marketing of any drug the use of which is prohibited in the country of origin.

{ Drugs and Cosmetic Act - India (pdf file) Download }

                      The committee felt that the DCGI should have gone into the reasons for the drug not being marketing in major developed countries such as United States, Britain, Ireland, Canada, Japan and Australia where there is greater demand for anti-depressants.




                  The committee sought immediate "concrete and exemplary action" by the ministry against functionaries of the CDSCO for the unlawful approval and reversal of the approval stating that it was "an open and shut case that needs immediate action, not promise of prolonged fruitless deliberation designed to delay action". "Why should the people of India consume a questionable drug approved in a questionable manner even for a day longer, more so when the drug regulator of the innovator country Denmark is not allowing its use within its jurisdiction but allowing its export to developing countries with weak or non-existent drug regulation? ", asked the committee.







                     In its May 2012 report the committee referred to several such cases of unlawful approval of drugs. But ten months later, beyond promising to constitute inquiry committees, no action has been taken against the officials who colluded neither have the approvals for these drugs been withdrawn.





                  "If perpetrators of such illegalities and collusive acts which are detrimental to public health are allowed to go scot-free then the total collapse of an ethical health care system is inevitable," stated the committee.