Indian pharmaceutical industry has been witnessing remarkable growth over past few years. It currently tops the chart amongst India's science-based industries with large ranging capabilities in the complex field of drug manufacture and technology. A highly organized sector, the Indian pharmaceutical industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 percent annually.
India is now among the five pharmaceutical emerging markets. There will be new drug launches, new drug filings, and Phase II clinic trials which are expected during this year (2015). The domestic pharmaceutical market is expected to register a strong double-digit growth of 13-14 per cent in the coming times. In the present article we enlist the key features of the Uniform Code of Pharmaceuticals Marketing Practices.
UNIFORM CODE OF PHARMACEUTICALS MARKETING PRACTICES (UCPMP)
Keeping in view the growth of pharmaceutical sector and with the intention to provide a uniform code with respect to pharmaceutical marketing practices, a uniform code of Pharmaceuticals marketing practices ("Code") has been introduced by the Department of Pharmaceuticals, Government of India on December 12, 2014 which became effective from 1 January 2015. It is expected to encourage good marketing practices by pharmaceutical companies. This Code prohibits companies from paying cash or monetary incentives to any healthcare professionals under any pretext and restricts pharmaceutical companies to provide free samples of drugs to any person, not qualified to prescribe such product.
It has been described in the Code that the information about the medicinal products must be accurate, balanced, fair, and objective and also must not mislead either directly or by implication. It is necessary to declare the clear information about the medicinal products because it may somehow cause danger to the consumers. The Pharmaceutical companies are not allowed to use the brand names of products of other companies in comparison unless the prior consent of the companies concerned has been obtained. All the adverse reactions and precautions for use of all the medicinal products must be mentioned so as to protect the consumers from any danger that the product can cause.
Further, as per the Code, the basic ingredients are very important to be mentioned on all the products with all the do's and don'ts on it. The Code declares that the entire medicinal product shall consist of the date of manufacturing of the product and also the date of expiration so that the public is aware of when to and when not to consume the product.
Promotional material such as mailings and journal advertisements of the medicinal products are not allowed to be designed as they disguise their real nature. If the pharmaceutical company pays for or otherwise secures or arranges the publication of promotional material in journals, the material must not match the editorial matter. The promotional material should not contain the names or photographs of healthcare professionals. Advertisement of the product is allowed but the companies should anyway try not to mislead the public. The free samples of medicinal products shall not be supplied to any person who is not qualified to prescribe such product. It must be supplied directly to a person qualified to prescribe such product or to a person authorized to receive the sample on their behalf. The person qualified to prescribe such product must be experienced in dealing with that kind of product. A person shall not supply a sample of a medicinal product which is an anti-depressant, hypnotic, sedative or tranquillizer.
As per the Medical Council of India Ethics Regulations 2002 amended in 2009, medical practitioners are not allowed to receive any gift from any pharmaceutical company or any allied healthcare organization or the representatives of such companies/industries. The MCI Ethics Regulations are applicable only on medical practitioners and not on pharmaceutical Companies. However, the Code has explicitly introduced the provisions that no gifts, pecuniary advantages or benefits in any kind may be supplied, offered or promised to persons qualified to prescribe or supply drugs, by a pharmaceutical company or its agents i.e. distributors, wholesalers, retailers etc.
Further, pharmaceutical companies or their associations are not allowed to extend any hospitality like hotel accommodation to healthcare practitioners and their family members under any pretext. They are also not allowed to pay any cash or monetary grants to any healthcare professional for individual purpose in individual capacity under any pretext.
All the Indian Pharmaceutical Manufacturer associations are under obligation to upload the Code on their websites. All the details as how the complaint shall be lodged should also be declared on the website. The present status of the complaint and what action has been taken on the complaint should remain uploaded for three years.
The Code also provides that in case a pharmaceutical company is not member of any association or member of more than one association, in such cases the complaint shall be handled by the Pharma Industry Association to whom the complainant has addressed the complain.
Every association is required to have a committee for handling complaint named as "Ethics Committee for Pharma Marketing Practices (ECPMP) which shall consist of 3 members. The Code also provides provision of a review committee for handling the review of the decisions of ECPMP and such committee is named as Apex Ethics Committee for Pharma Marketing Practices (AECPMP) which shall consist of 5 members. The complaints that are lodged must be in writing and also the Complainant should identify himself, identify the company, give the details of the breach of the code, and also the supporting evidence. An amount of Rs. 1000 has to be paid by the complainant who is nonrefundable and the associations will elaborate how this payment is to be made.
The UCPMP sends a message of intent of the Government that all the pharmaceutical companies adopt uniformity in pharmaceutical marketing practices in India. Undoubtedly, the recent Code is a positive step towards uniformity on pharmaceuticals marketing practices throughout the country in absence of any regulatory framework. Even though this Code is voluntary in nature, however it is explicitly mentioned in the Code that if this Code is not implemented effectively by pharma associations/companies, the Government may consider making it a statutory code. We await the Compliace of the said code by the companies and the decision of the Government at a later stage to make the Compliance of the Code mandatory.
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.