India: Uniform Code Of Pharmaceuticals Marketing Practices, 2014–Expected To Be Made Mandatory Soon

Last Updated: 10 May 2017
Article by Gunita Pahwa

Most Read Contributor in India, July 2017

The Uniform Code of Pharmaceuticals Marketing Practices, 2014 ("UCPMP Code") is a voluntary code issued by the Department Of Pharmaceuticals ("the Department") relating to marketing practices for Indian Pharmaceutical Companies and as well medical devices industry. Although the UCPMP Code was initially implemented for a period of 6 months; however, after being extended by the Department 5 times, the Department vide its notification bearing no. 5/3/2009-PJ-J/PJ-II (Vol.III) dated 30 August 2016 has extended the UCPMP Code, 2014 till further orders.

In addition to the above, as per recent news reports, the Department is in the final stages of issuing an executive order making the UCPMP Code mandatory for the drug manufacturing industry. It is expected that the order will cover doctors, chemists, hospitals, and states. Further, it is also expected that there could be inclusion of the stringent penalty provisions in the UCPMP Code.

At present, the UCPMP Code is applicable on Pharmaceutical Companies, Medical Representatives, Agents of Pharmaceutical Companies such as Distributors, Wholesalers, Retailers, and Pharmaceutical Manufacturer's Associations. Interestingly, the UCPMP Code under the head of "Relationship with Health Care Professionals" also provides that where there is any item missing the Code of MCI as per "Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 ("MCI Regulations") as amended from time to time, will prevail.

The UCPMP Code provides that 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. In view of the judgment of the ITAT, Mumbai, in the matter titled "The Assistant Commissioner of Income Tax Circle 6 (3) vs. Liva Healthcare Limited"1, the definition of gifts under the UCPMP Code includes gifts for the personal benefit of HCPs and family members (such as tickets to entertainment events, etc.).

Further, as regards travel facilities, the UCPMP Code prohibits extending 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. Interestingly, the UCPMP Code does not provide any restrictions for extending travel facilities attending seminars, workshops, CME programs, as other than delegates, for instance attending as a lecturer, speaker, faculty member, etc.

Additionally, the UCPMP Code's regulations regarding Hospitality and Cash or Monetary Grant are same as the MCI Regulations. However, the UCPMP Code does not quantify any allowable limits or any penalty/ punishment based on the quantification of grants.

The UCPMP Code also provides that free samples of drugs shall not be supplied to any person who is not qualified to prescribe such product. Meaning thereby that free samples can only be supplied to persons qualified to prescribe such product. In addition to the above, the UCPMP Code also prescribes additional conditions that are to be observed while providing samples. Interestingly, the UCPMP Code provides limitations on the distribution of free samples, whereas the MCI Regulations do not provide for the same, namely that the sample packs shall be limited to prescribed dosages for three patients for required course of treatment, the sample pack shall not be larger than the smallest pack present in the market, etc.

Further, as per the UCPMP Code, in order to appoint Medical Practitioners/HCPs as Affiliates there should be written contract, legitimate need for the services must be documented, and criteria for selecting affiliates must be directly related to the identified need. Furthermore, the Affiliates must have the expertise necessary to provide the service and should not provide services /attend meets unrelated to the services agreed under the said agreement. The UCPMP Code also provides that the number of affiliates retained must not be greater than the number reasonably necessary to achieve the identified need and that the compensation must be reasonable and reflect the fair market value of the services provided.

Presently, the UCPMP Code suggests that the committee can propose one of the following decisions against the alleged company to the Head of the Association: (i) suspend or expel the company from the Association, (ii) reprimand the company and publish details of that reprimand, (iii) require the company to issue a corrective statement in the media (covering all media), or (iv) ask the company to recover items from the concerned persons, given in violation of the UCPMP Code, 2014. However, as per recent news reports, the penalties under the UCPMP Code are expected to be revised by the Department and that the Department is planning to bring more stringent penalties clauses under this Code such as suspension of product marketing in case of violation.

Footnote

1 (I.T.A. Nos. 904 and 945/Mum/2013) Decided on 12.09.2016

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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