Irrational combinations, Rajasthan DC seeks DCGI's response

The Rajasthan State Drugs Control Department has taken serious note of the list of "irrational combinations" prepared by a leading medical journal and sought advice from the Drugs Controller General of India (DCGI) on how to put an end to the "alleged" presence of all these "dubious" fixed-dose combinations and drugs discarded or not used in the developed world. In a letter to the DCGI with copies to all state drug controllers as well as formulation committees and the state drug traders association, the state drug controller wanted to know if there is DCGI approval for all the drugs that are mentioned in the list. Directly referring to the list published by Monthly Index of Medical Specialities (MIMS), the drug controller explained that "as a practice, the applicants while seeking approval / product permission, quote the reference of similar / parallel products being manufactured and traded in the country, leaving hardly any scope for a state licensing authority to think twice before releasing approvals". Hence he wanted the DCGI to issue instruction about the locustandi and instruction for such combinations.

According to editor, MIMS, almost all these combinations are marketed without DCGI approval in the country. "These partial, cumulative list of dubious fixed-dose combinations (FDCs) are available in India but not approved in any developed country. Many of these combinations are not approved by the Drugs Controller General, India and hence illegal", he explained.