The Department of Pharmaceuticals (DoP) has clarified that the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP), which the department had implemented voluntarily for a period of six months with effect from January 1, 2015, will be applicable to medical devices industry too.

By issuing the clarification order, the DoP has cleared the confusion of the industry about the applicability of UCPMP on medical devices industry.

There was confusion among the industry whether the UCPMP will be applicable to medical devices industry as there was no special mention about the medical devices industry in the UCPMP issued by the DoP last year.  In order to get clarification on the issue, several industry associations had approached the department.

Earlier in November last year, after several years of dilly-dallying on the issue, the (DoP) had issued the much awaited UCPMP which should be voluntarily adopted and complied with by the pharma industry for a period of six months with effect from January 1, 2015 and it would be reviewed thereafter on the basis of the inputs received by the department.

As per the UCPMP, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply drugs, by a pharmaceutical company or any of its agents i.e. distributors, wholesalers, retailers, etc. Gifts for the personal benefit of healthcare professionals and family members (both immediate and extended) (such as tickets to entertainment events) also are not be offered or provided.

The new document further says that companies or their associations/representatives or any person acting on their behalf shall not extend any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations, etc., to healthcare professionals and their family members for vacation or for attending conference, seminars, workshops, CME programme etc. as a delegate.

Besides, companies should not extend any hospitality like hotel accommodation to healthcare practitioners and their family members under any pretext.  Companies should not pay any cash or monetary grants to any healthcare professional for individual purpose in individual capacity under any pretext. Funding for medical research, study etc, can only be extended through approved institutions by modalities laid down by law/rules/guidelines adopted by such approved institutions, in a transparent manner.

As per the new UCPMP, free samples of drugs shall not be supplied to any person who is not qualified to prescribe such product. Where samples of products are distributed by a medical representative, the sample must be handed directly to a person qualified to prescribe such product or to a person authorised to receive the sample on their behalf.

The managing director/CEO of the company is ultimately responsible for ensuring the adherence to the code and a self declaration should be submitted by the executive head of the company within two months of date of issue of UCPMP and thereafter within two months of end of every financial year to the Industry Association for uploading the same on the website of the Association. The same must be uploaded on the website of the company also.