Introduction
The Department of Pharmaceuticals has recently released the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024 (‘Code of 2024’) with regard to marketing practices applicable on Pharmaceutical Associations, Pharma Companies and Medical Devices organizations. Previously the department had released the Uniform Code for Pharmaceutical Marketing Practices, 2014 (‘Code of 2014’).
Key Highlights
- Information about drugs must be balanced, up- to- date, empirical, must not mislead either directly or by counteraccusation; directly reflect current knowledge or responsible opinion; and must be able of validation, which must be handed without detention, at request of the members of the medical and drugstore professions, including members of other professions employed in the pharmaceutical industry.
- Claims for the utility of a medicine must be grounded on up- to- date evaluation of all available substantiation.
- Brand names of products of other companies must n’t be used in comparison unless the previous concurrence of the companies concerned has been attained.
- Other companies, their products, services, or upgrades must not be disparaged either directly or by implication.
- The word “safe” must not be used without qualification, and it must not be stated categorically that a medicine has no side effects, toxic hazards, or risk of addiction.
- The word “new” must not be used to describe any drug which has been generally available or any therapeutic intervention which has been generally promoted in India for more than a year.
Brand Reminder
- Informational and Educational Particulars: Means books, calendars, diaries, journals (including e-journals), dummy device models and clinical treatment guidelines for professional used in healthcare settings value of which does not exceed Rs. 1000 per item.
- Samples Provided by the Companies
- Each company should maintain details such as product name, doctor name, quantity of samples given, date of supply of free samples to healthcare practitioners etc. and the financial value of samples so distributed should not exceed two percent of the domestic deals of the company per year.
- Samples of products are distributed by a medical representative, the sample must be handed directly to the person qualified to prescribe similar product, or to a person authorized to receive the sample on their behalf, and the name and address of the healthcare practitioner noted for records.
Restrictions
- It is forbidden to give free drug samples to anyone who isn’t authorized to prescribe them.
- A sample of a medication that is a sedative, tranquilizer, or hypnotist cannot be provided by a pharmaceutical manufacturer.
Comparison
| UCPMP 2014 | UCPMP 2024 |
|---|---|
| UCPMP 2014 was based on voluntary terms | Whereas UCPMP 2024 is based on mandatory terms |
| Clear definition of promotion was not clearly available | Clear definition of promotion was available which includes prescription, supply, purchase and use of medical drugs |
| There was no provision regarding continuing Medical Education CME in 2014 | Introduction of Continuing Medical Education (CME) guidelines. |
Complaint Mechanism
- All complaints, related to the breach of the Code should be addressed to the “Ethics Committee for Pharma Marketing Practices (ECPMP).
- Complaints must be in writing and for each case The Complainant should
- identify himself with a full mailing address.
- identify the company, which is contended to have traduced the Code
- When the complaint is from a pharmaceutical company, the complaint must be signed or authorized in writing by the company’s managing director or chief executive officer or a person at an equivalent level
- Any complaint received by the Department of Pharmaceuticals may also be forwarded to the concerned Association for necessary action.
Other Changes
- Provisions relating to Continuing Medical Education with regard to Engagement of pharmaceutical industry with the healthcare professionals for Continuing Medical Education (CME), Continuing Professional Development (CPD) or otherwise for conference, seminar, workshop, etc. has been inserted.
- Provision relating to Support for Research has been inserted.
- Creation of Ethics Committee for Pharma Marketing Practices in each Pharmaceutical Association.
Enhanced authority to the overseeing Ethics Committee, empowering it to forward its recommendations to relevant government agencies through the Department of Pharmaceuticals (DoP). The impact of this being possible of scrutiny by statutory bodies and breaching companies being responsible under applicable legislations, similar as the medicines and Cosmetics Act, 1940.
Conclusion
A review of both the Codes it can be seen that the code of 2014 was voluntary in nature and the Code of 2024 does not uses the word voluntary and urges the companies to implement the provisions of the Code of 2024. Though majority of the provisions of the Code of 2014 have been inculcated in the Code of 2024, the Department has not expressly repealed or issued any clarification with regard to the enforceability of the Code of 2014. Therefore, it is prudent that the companies on whom the provisions of both the codes are applicable comply with both the codes until a clarification is received from the Department of Pharmaceuticals in this regard.
Disclaimer
The information provided in this article is intended for general informational purposes only and should not be construed as legal advice. The content of this article is not intended to create and receipt of it does not constitute any relationship. Readers should not act upon this information without seeking professional legal counsel.
