|Author(s):||M. D. Janodia*1, S. Dharmagadda1, V. S. Ligade1, A. P1, N. Udupa1|
|Affiliation(s):||1Pharmacy Management, Manipal College of Pharmceutical Sciences, Manipal, India|
|Keywords:||Irrational drug combination, public health|
Curbing the use of irrational drug combinations is vital to safeguard public health. Use of drug combinations should be based on scientific rationale and evaluation of its safety and efficacy. Several such irrational drug combinations have flooded Indian market where Drug Controller General of India (DCGI), the highest authority granting marketing approval of drug, had not granted approval to market these drugs and these drug combinations are not available in any developed country.
|Summary/Objectives:||To study the status of irrational drug combinations and actions taken by the government of India and DCGI.|
There are more than 1000 brands in India that consist of irrational drug combinations. These brands and combinations are not tested for safety and efficacy and there is no scientific rationale of marketing these irrational drug combinations. Out of total of 294 combinations that are suspected to be irrational, DCGI classified them as Absurd, Banned, Rejected, Need for examination, Decision Taken and Approved. These combinations are marketed by some of the well known and top companies. Out of 294 combinations under review, the DCGI has asked to withdraw 120 combinations which industry has agreed to. On the other hand the drug combinations are required in the market that has therapeutic efficacy and are tested and evaluated for safety and are driven by scientific rationale. For example, combination drugs for AIDS that is essential as each drug in the combination has different mode of action for delaying the progression of disease and which is scientifically tested. DCGI taking proactive steps is trying to curb the marketing of irrational drug combinations and safeguarding public health. It is required that the drug licensing authority be given enough powers to approve the drugs for marketing that has scientific value.
Drug combinations that are proven safe and efficacious scientifically for therapeutic value is required in the market so as to make drug therapy effective whereas irrational drug combinations poses a serious threat to the healthcare of people must not be allowed to be marketed and need to be dealt with stringently.