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Laxmi Yadav, Mumbai July 14 , 2020
The drug industry has urged the Central Drugs Standard Control Organisation (CDSCO) to roll back the proposed plan to introduce changes in performance enhancing drug (doping drug) labels by putting either a vertical orange line or a line of any other colour on the drug packs to curtail the prescription medicine misuse.

There is adequate information on the label of performance enhancing drugs which are basically prescription drugs to state that “for prescription only” and to further distinguish the same, as performance drugs does not serve any purpose, said the industry.

All these performance enhancing drugs (barring illegal substances) fall under Schedule H, H1 or X or NDPS category wherein the labelling requirement is NRx. These drugs prohibited by the National Anti-Doping Agency (NADA) and World Anti-Doping Agency (WADA) are sold based on prescriptions of registered medical practitioners (RMPs). Hence, awareness to RMPs should be done through the Medical Council of India to ensure that these are not misused. The drug pack carries printed warning "not to be sold by retail without the prescription of a registered medical practitioner" and to further differentiate the same, as performance drugs will hardly serve any purpose, said Indian Drug Manufacturers’ Association (IDMA) in a representation to CDSCO on formulation of guidelines for labelling of performance enhancing drugs.

Enforcement of prescription drugs by state food and drugs administration will curb the misuse of doping drugs. There have been too many changes in the labelling requirements and the label is already very crowded. For example, it is not practical to include anything on a small volume injection ampoule, said the industry body.

Labelling changes should be reviewed, changed and notified, once in 5 years and implemented after giving adequate time of 12 months, for managing packaging inventory. Industry typically has 9-12 months packaging inventory, at any given point of time and any ad hoc implementation of labelling changes impact availability of medicines and disruption in the supply chain, as designing, artwork, printing, current inventory of packaging material has to be managed, it stated.

The prohibited list is dynamic and is revised by WADA on an annual basis. This would be difficult to implement and enforce if the labelling requirement and changes are dynamic in nature. This would create huge impediments for industry and trade, added IDMA.

Said Devesh Malladi, chairman, NDPS Committee, IDMA, “The labelling change will not serve the purpose of preventing misuse of performance enhancing drugs. These prescription drugs should be available on the doctor’s prescription only. There is no case of consumer awareness when the drugs are meant for sale through doctor’s prescription. The awareness needs to be created among consumers when the products are sold to them directly. Instead of changing drug labels, the government can sensitize medical practitioners through MCI about prescribing performance enhancing drugs with due care. The strict enforcement by FDA authorities to ensure that performance enhancing drugs are sold on the prescription of physicians will rein in abuse of these drugs."

He said, "Over the last five years, CDSCO has introduced several changes to drug packs. Now one more change in the drug pack is under consideration. Frequent labelling changes will lead to short supply of drugs rather than addressing issues because the drug units need time to manage artwork, printing and current inventory of packaging material etc.”

At a virtual meeting chaired by deputy drugs controller (India) AK Pradhan at the CDSCO office on June 23, 2020, representatives of the drug industry were asked to submit their suggestions on performance enhancing drug labels.

Pradhan suggested that the labels of all such drugs should be marked with either a vertical orange line or a line of any other colour for smooth identification and to ensure that these drugs are taken on the prescription of doctors. The list of doping drugs banned by WADA and NADA should be made available to the public, teachers, parents, students, sportspersons, doctors etc. for their knowledge, he said.

The CDSCO’s move came after it has received representations from the general public and Prime Minister Office Grievance cell seeking development of guidelines for labelling of doping drugs.

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