UCPMP COMPRESSED

Uniform Code for Pharmaceutical Marketing Practices (UCPMP) which was first launched as a Guidance document effective from 2015, had been extended from June,2016 till further orders. UCPMP serves as a guidance document for Pharma Marketing practices. It is supposed to be converted into a Law but the final verdict on this matter is still pending with the authorities. Albeit, Pharma regulation authorities want UCPMP to be followed by companies operational in Pharma Domain in India. UCPMP govt. Notification

Key Features of UCPMP Guidance document

  1. Claims of Drugs:
  • Claims for usefulness of a drug must be based on an up-to-date evaluation of all the evidence.
  • The word “new” must not be used for any drug which has been generally available, or therapeutic indication which has been generally promoted, in India for more than 12 months.
  • The word “safe” must not be used without any qualification and it must not be state categorically that a medicine has no side effects, toxic hazards or risk of addiction.
  1. Comparison of drugs
  • Comparison of drugs must be factual, fair and capable of substantiation. In presenting a comparison, care must be taken to ensure that it does not mislead by distortion, by undue emphasis, omission or any other way
  • Brand name of other companies must not be used on comparison unless the prior consent of the companies concerned has been taken.
  • Other companies, their products, services or promotions must not be disparaged either directly or by implication.
  1. Textual & Audio-Visual Promotional Material
  • Promotional material such as mailings and journal advertisements must not be designed to disguise their real nature. Where a pharmaceutical company pays for or otherwise secures or arranges the publication of promotional material in journals, such promotional material must not resemble editorial matter.
  • Where the purpose of promotional material is to provide persons qualified to prescribe or supply with sufficient information upon which to reach a decision for prescribing or for use, then the following minimum information, must be given clearly and legibly and must be an integral part of the promotional material:
  • The relevant drug, the name and address of the holder of the authorization of the drug or the business name and address of the part of the business responsible for placing the drug on the market
  • The name of the drug and a list of the active ingredients using the generic name, placed immediately adjacent to the most prominent display of the name of the drug;
  • Recommended dosage, method of use and where not obvious, method of administration;
  • Adverse reactions, warnings and precautions for use and relevant contraindications of the product;
  • A statement that additional information is available on request;
  • The date on which the above particulars were generated or last updated.
  • All promotional materials appearing in journals, the publication of which is paid for or secured or arranged by a company and referring by brand name to any product of that company, must comply with (the requirements immediately above) as appropriate, irrespective of the editorial control of the material published.
  • Promotional material must conform, both in text and illustration, to canons of good taste and must be expressed so as to recognize the professional standing of the recipients and not be likely to cause offence.
  • The names or photographs of healthcare professionals must not be used in promotional material.
  • Promotional material must not imitate the devices, copy slogans or general layout adopted by other companies in a way that is likely to mislead or confuse.
  • Where appropriate (for example, in technical and other informative material), the date of printing or of the last review of promotional material must be stated.
  • Postcards, other exposed mailings, envelopes or wrappers must not carry matter which might be regarded as advertising to the lay public or which could be considered unsuitable for public view.
  • Audio-visual material must be supported by all relevant printed material so that all relevant requirements of the Code are complied with. 
  1. Medical Representative
  • The term Medical representative means sales representatives, including personnel retained by way of contract with third parties & any other company representative who call on healthcare professionals, pharmacies, hospitals or healthcare facilities in connection with promotion of Drugs.
  • Medical representatives must at all times maintain a high standard of ethical conduct in the discharge of their duties. They must comply with all relevant requirements of the Code.
  • Medical representatives must not employ any inducement or subterfuge (deceit) to gain an interview. They must not pay, under any guise for access to healthcare professionals.
  • Companies are responsible for the actions of all of their employees including Medical Representatives for ensuring compliance of code. This would be additionalyy ensured by the companies through appropriate clause in the contract of the employment between companies & it’s employees/Medical Representatives.
  • Other third parties working for or on behalf of pharmaceutical companies, and those who do not work on the behalf of the companies (Such as joint ventures & Licensees) commissioned to engage in activities covered by the Code should also have a good working knowledge of the Code.
  1. Samples
  • 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 authorized to receive the sample on their behalf.
  • The following conditions shall be observed in the provision of samples to a person qualified to prescribe such product:
  • Such samples are provided on an exceptional basis only (see (ii) to (vii) below) and for the purpose of acquiring experience in dealing with such a product
  • Such sample packs shall be limited to prescribed dosages for three patients for required course of treatment;
  • Any supply of such samples must be in response to a signed and dated request from the recipient;
  • An adequate system of control and accountability must be maintained in respect of the supply of such samples;
  • Each sample pack shall not be larger than the smallest pack present in the market.
  • Each sample shall be marked “free medical sample – not for sale” or bear another legend of analogous meaning;
  • Each sample shall be accompanied by a copy of the most up-to-date version of the Product Information (As required in Drug and Cosmetic Act, 1940) relating to that product
  • A pharmaceutical company shall not supply a sample of a drug which is an antidepressant, hypnotic, sedative or tranquillizer.
  • The companies will maintain details, such as product name, doctor name, quantity of samples given, Date of supply of free samples distributed to Healthcare practitioners etc. 
  1. Gifts
  • 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. 
  1. Relationship with Health Care Professional
  • Travel facilities: 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 Health Care Professionals and their family members for vacation or for attending conference, seminars, workshops, CME programme etc. as a delegate. It is hereby clarified that in any seminar, conference or meeting organized by a pharmaceutical company for promoting a drug or disseminating information, if a medical practitioner participates as a delegate, it will be at his/her own cost.
  • Hospitality: Companies or their associations/ representatives shall not extend any hospitality like hotel accommodation to Healthcare Practitioners and their family members under any pretext.
  • Cash or monetary grants: Companies or their associations/representatives shall 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, can only be extended through approved institutions by modalities laid down by law/ rules/guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed.

 

References

http://pharmaceuticals.gov.in/sites/default/files/001_0.pdf

http://pharmaceuticals.gov.in/sites/default/files/Uniform%20Code%20of%20Pharmaceuticals.pdf

 

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