To regulate the unethical pharmaceutical marketing practices in India, the Department of Pharmaceutical (DoP) on 12th March 2024 formulated guidelines with the aim of increasing transparency and promote integrity in relation to the marketing of pharmaceutical products especially pertaining to “Pharmaceutical Drugs” as well as the “Medical Devices” across the nation.
Uniform Code for Pharmaceutical Marketing Practices (hereinafter referred to as “UCPMP” or “Code”) laid down some key compliances/guidelines to be followed by the key players in the pharma sector to reduce unethical practices. The Code also explicitly states procedure in case of lodging a Complaint and penalties imposed on the market participants.
This Code is applicable to various entities involving pharmaceutical companies, manufacturers, agents, wholesalers and distributors of medicinal drugs and medical devices.
Key Features/ Guidelines under this Code
Promotional Activities for Pharmaceutical Products
In terms of promotion, the Pharmaceutical Companies, manufacturers, wholesalers, agents, and distributors (hereinafter referred to as “Market Participants”) must adhere to a set guideline when promoting their products across the nation.
UCPMP provides clarity over promotional guidelines, and it only allows the market participants to promote their products by providing Correct Information to end users of the product.
Key Compliances Mandated for Market Participants to Promote Their Product
- Market Participants are required to obtain prior permission/approval from the Competent Authority in terms of marketing their pharmaceutical product across the nation.
- A request shall be made by the Market Participants to the Competent Authority furnishing accurate, balanced and up-to date information of the pharmaceutical product to seek prior permission for marketing their products across the nation.
- Once the approval is granted by the Competent Authority, only then the said market participants are allowed to market their products in terms of sale and distribution.
Do’s and Don’ts for Market Participants
Claims related to the usefulness of the Drug/ medical devices must be supported by evidence along with an up-to-date report.
Market Participants should not use the words “Safe” and “New” in promoting their products in terms where they do not have sufficient proof to support their claim.
Generally, while promoting the products, the market participants should not compare their products with different brands as it falls under the ambit of unethical practice, unless permission has been obtained.
While carrying out promotional campaigns, the market participant is required to check that the information on the products is in conformity with the Code i.e., the text on product should be legible, and should specify the accurate details of the product being marketed. The content must be verified by the Authority.
Are Market Participants allowed to appoint “Medical Representative” for carrying out Promotions of their Products?
In order to understand the role of medical representatives in accordance with the Code, it is important to understand the meaning of a “Medical Representative” first.
Medical Representatives refers to the individuals/entities appointed by the Pharmaceutical Companies for the purpose of making sale of their products. They are generally sales representatives wherein their role is to sell/promote the products of the Pharmaceutical Companies by reaching out to the various entities involving pharmacies, Health Care Professionals (HCP), Hospitals or health care facilities.
Rules to be adhered by the Medical Representatives
The following rules must be followed by the Medical Representatives-
- They should not engage in any illicit activities for promotion of the products.
- They should not use any unethical ways to promote the products to HCP, pharmacies etc.
NOTE: Apart from the Medical Representatives, this Code also covers “Third parties” being appointed by the market participant in carrying out the promotional activities. The Pharmaceutical companies are responsible for the acts committed by the Medical Representatives and Third Parties.
Are Market Participants allowed to send Brand Reminders for promotion of their Products to Health care Professionals?
Companies engaged in the business of providing pharmaceutical products are allowed to send brand reminders to the health care professionals only through these modes:
- Informational and Educational items (Informational promotion can be done by sending books, journals etc. to the health care professionals)
- By way of providing sample items only to qualified people for creating awareness.
- Responsibility of the Market Participants along with Health Care Professionals in providing Continuing Medical Education/ Continuing Professional Development
- Entities which are responsible for conducting workshops and seminars for providing medical education/ professional development are generally medical colleges, teaching institutions, hospitals, professional associations of doctors, research institutions, pharmaceutical companies (including their trusts/associations), and laboratories of DBT, ICMR, CSIR etc.
- In General, Pharmaceutical Companies are not allowed to conduct any CME/CPD programs outside India without the prior approval of the Competent Authority.
Can Pharmaceutical Companies Seek Support from Health Care Professionals in Case of any Drug Research/ Innovation?
To seek assistance from the Health Care Professionals in relation to any research/ innovation, the Pharmaceutical Companies are required to obtain prior permission from the Competent Authority. (such as ICMR, Ethics Committee, DCGI, Institutional Authority etc.)
Key requirements to be followed by both the parties:
- A consultancy agreement needs to be formed and executed between the parties.
- Only Advisory Services shall be rendered by the Health Care Professional.
- Total Expenditure incurred on research by the pharmaceutical company shall be treated as an allowable expenditure as per the provisions of the Income Tax Act.
Are Heath Care Professionals entitled to receive any monetary benefits in the form of Gifts, travel facilities, monetary grants and Hospitality facilities?
Health Care Professionals are not entitled to receive any benefits in terms of Gifts, travel facilities, grants as well as Hospitality facilities. The Code strictly prohibits the Pharmaceutical Companies or their representatives from providing any of the benefits to the Health Care professionals.
Exception:
Travel and Hospitality Facilities can be provided by the Companies to the Health Care Professional in cases where they are invited as a speaker for a CME/CPD Program.
Complaint Mechanism under this Code
The process of filing a Complaint in case of a breach is as follows:
- In case of any breach in respect of the Code, the complainant can file a complaint with the Ethics Committee for Pharma Marketing Practices (ECPMP).
- The complaint must be filed within the period of 6 months of the alleged breach.
- In case of a reasonable delay in filing of Complaint, the complaint is provided with additional six months in order to file the Complaint.
- Generally, a non-refundable amount of Rs 1000/- is required to be deposited with the Complainant along with the Complaint.
- A response to the complaint must be filed within the 30 days of the receipt of the complaint.
- Once the complaint is filed, generally an enquiry is conducted by the Association in respect of the breach. In case of any breach, both the parties will be required to take reasonable action to rectify the same.
- The Committee will pass an order within the first 90-day period on receipt of the complaint.
- If an appeal is not filed within the stipulated time i.e. 15 days, before the Apex Committee for Pharma Marketing Practices (ACPMP), the ECPMP shall pass an order and the decision will be binding upon the parties.
Penalties under this Mechanism:
Once the Committee establishes that a breach has been committed, the following are the penalties which are imposed on the party:
- The committee shall either suspend or expel the organization involved in committing the breach.
- The committee shall reprimand the organization.
- The Committee can direct the organization to issue a corrective statement in relation to the breach.
- The committee may direct the organization to recover the money in accordance with the code.
- In case, there is any disciplinary issue, penal or remedial action lies within the ambit of the authority of Government of India. However, the Committee may send a report/ recommendation to the authority through DOP.
Way Forward
In India, there are various laws pertaining to the regulation of Drugs including:
- The Drugs and Cosmetics Act, 1940
- The Drugs and Magic Remedies (objectionable Advertisement) Act 1954
- Consumer Protection Act, 1986
Conclusion
Henceforth, with the implementation of this Code, uniformity in carrying out “promotional activities” is established for various market participants in relation to their pharmaceutical products. The initiative to establish a committee is a great way to deal with the issues falling under this code. Overall, the Code regulates unethical pharmaceutical marketing practices with a balanced approach in hand. The guidelines laid will have positive impact on the Indian Pharmaceutical Sector.
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