CDSCO asks industry to submit suggestions on doping drug labels

The Central Drugs Standard Control Organisation (CDSCO) has asked the pharma stakeholders to submit their suggestions on doping drug (performance-enhancing drugs) labels. It has also stressed that the suggestions should be made after taking visually impaired persons into consideration and should be user friendly.

The issue was discussed on a virtual meeting held on June 23, 2020, at the CDSCO office, chaired by A K Pardhan, DDC (I) and attended by key industry stakeholders. During the meeting, Pradhan informed that the CDSCO office has received representations from general public and Prime Minister Office Grievance cell seeking formulation of guidelines for labelling of performance-enhancing drugs (doping drugs). He also stated that the list of doping drugs which are banned by World Anti-Doping Agency (WADA) and National Anti-Doping Agency (NADA) should be made available to the public, teachers, parents, students, sportspersons, doctors etc. for their knowledge. He also recommended that the labels of all such drugs should be marked with either a vertical “Orange” line or a line of any other colour line for easy and convenient identification and to ensure that these drugs are not used without medical supervision/advice.

Since these medicines are scheduled formulations and are prescribed for certain conditions under the supervision of registered medical practitioners, they need to be given in the right dosages. However, it has been noticed that these medicines are being consumed by athletes, gym-going people etc., without any prescriptions.

Reportedly, the matter will be placed before the Drugs Technical Advisory Board (DTAB) and they will prepare draft guidelines. The doping drug list may be put in the public domain for the knowledge of the public as well as for medical professionals, etc. and an awareness campaign may be undertaken to avoid misuse of such drugs.

Sharing his views on this issue, Devesh Malladi, Chairman, NDPS Committee, IDMA informed, “Since all the performance or doping drugs fall under the Schedule -‘H’, ‘H1’ ‘X’ category or labelled as NRx (Schedule H narcotics drugs) for the Narcotic Drugs and Psychotropic Substances (NDPS) drugs as per the Drugs and Cosmetic Rules, and are required to be sold by retailers, on the prescription of registered medical practitioners only, there is no need to make any changes in the labelling.”

He elaborated, “Instead of putting an extra orange line on the label for performance or doping drugs, which is already overcrowded with no space available, it is advisable to ensure strict enforcement by the FDA authorities to dispense medicines with valid prescriptions, only. This is a legitimate solution to the problem of misuse of performance or doping drugs.”

He further suggested, “Considering these medicines are prescription only, the Medical Council of India should issue advisories and create awareness amongst registered medical practitioners.”

“In recent years, several changes to labelling requirements and consequent notifications have created impediments to the industry in implementing these changes, as the typical inventory of packaging material and labels is approximately six-nine months. This leads to recalls, supply chain disruptions and availability of medicines. Besides this, NADA’s Prohibited or Doping list is updated every year and such dynamic changes are not possible to implement if specific labelling requirements are introduced for performance-based drugs or doping drugs,” he added.

He added that IDMA will be submitting these recommendations to the CDSCO.