Healthy Skepticism Library item: 13557

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Shrivastav S.
A shocking WHO dunit: GMCH Researchers Find That Many Indian Pharma Cos Are Using Name of WHO Illegally For Promotions
Times of India 2008 Apr 22
http://epaper.timesofindia.com/Daily/skins/TOI/navigator.asp?Daily=NGTOI&login=default&AW=1209077315656

Full text:

Most of us have seen the logo ‘WHO certified’ or ‘WHO recommended’ on packaging of medicinal drugs, mosquito repellants, nutritional supplements and even bottled water. What most of us don’t know is that using the name or logo of the World Health Organisation for advertisement or promotional activity is illegal.

Despite warnings from the South East Asia Regional Office (SEARO) of World Health Organisation (WHO), New Delhi, many pharma companies in hundreds of cases across the country are blatantly using the WHO name, logo, seal or certification for promoting their products. By doing so they are not just misleading the consumers but also grossly violating WHO norms.

Wockhardt, Lupin, Sanofi Aventis, Yash Pharma and Strides Acrolab Limited are some among those issued warning letters by the WHO office in recent past to withdraw such promotional material.

n fact, a study – the first of its kind in the world – conducted by two researchers from Government Medical College and Hospital (GMCH) in the city has brought to fore that pharma companies are illegally using WHO to promote their brand in some form or other in as many as 121 cases. Dr Vijay Thawani, associate professor, pharmacology department, GMCH, is the principal invesigator of the project and Kunda Gharpure, research pharmacist with GMCH is the co-investigator.

However, the WHO apparently does nothing beyond issuing warning letters as it is just an international recommender organisation without any direct control over the legal system of individual member states who are expected to initiate steps to deter those who are indulging in such misuse.

When contacted, the WHO, SEARO Office, New Delhi, did not respond to any of the three e-mails sent to it. Even the Drug Controller General of India (DCGI) office at New Delhi told the TOI to send queries about the issue through email. But neither the DCGI not his subordinates responded to three emails sent to them. Companies like Ciron Drugs and Pharmaceuticals limited, Lupin Limited, Strides Acrolab Limited, Wockhardt, Themis Medicare Limited, Sanofi aventis did not respond either, when contacted on phone and e-mail.

The findings of the study spanning over three years titled ‘Vigilance of promotional activities using WHO name and logo in India’ were also presented at the WHO technical briefing seminar at WHO Headquarters in Geneva, Switzerland in November 2007. But unfortunately, other than generating a lot of concern, apparently even the WHO has left it for Indian government to take the right action against its undisciplined industry.

“As per existing regulations, no drug manufacturer can use the WHO name in any advertisement or promotional activity of their products. This is because WHO never issues any permission to any industry for use of its reference, logo, name or certification in any advertisements, products, communications, business cards or any written or published material’‘
said Gharpure.

Dr Thawani added: “These companies are not just violating the norms of ethical promotion but are grossly misleading the consumers. Some companies have fabricated bogus WHO seals and certification nomenclature for propping up their products and services which is strictly prohibited as per WHO regulations.

He says that even if WHO (India) wants to take some action, it has limited manpower and almost no mechanism to screen the huge promotional material generated by pharma industry. Considering himself as a vigilant activist, Dr Thawani says, “We are the eyes and ears of the WHO.”

The WHO examines the specific complaint of misuse of its name or logo and if found objectionable, issues a “standard letter” containing warning to respective company or institution to withdraw the promo. A copy of the “standard letter” is marked to the health ministry of the country, WHO representative for the country and legal cell of WHO. But all this happens when the misuse is reported. “Others continue to use the WHO name and its logo to prop up their brand,” says Dr
Thawani, “and get away with it.”

Some erring companies

Of the 120 identified manufacturers from India, some leading examples are:

Sanofi Aventis, GlaxoSmithKline Biologicals, Chiron Vaccines, Raptakos Brett & Co Ltd, Bharat Serums & Vaccines Ltd, Ranbaxy, Themis Medicare Limited, Chandra Bhagat Pharma Pvt Ltd, Virchow Biotech Private Ltd, Geno Pharmaceuticals Ltd, Knight etc have misused WHO name in advertisements.

Wockhardt, Themis Medicare Ltd, Tablets (India) Limited, Saga Laboratories, Systopic, Biomiicron Pharmaceuticals, etc have misused the WHO logo in promotional activities.

Lincoln Pharmaceuticals, Sanofi-Aventis, MAAN Pharmaceuticals Limited, etc have used WHO name on gifts or calendars.

Finecure Pharmaceuticals Limited, Genesis Biotech Inc, D R John’s Lab Pvt Ltd, East African (India) Overseas, Aileron Life Sciences Pvt Ltd, Flamingo Pharmaceuticals Ltd, Elegant Drugs Pvt Ltd, Osper Formulations, Wincoat Colours & Coatings Pvt Ltd, etc have wrongly quoted WHO Good Manufacturing Practices (GMP) certification.

Dabur Pharmaceuticals Ltd, Lincoln Pharmaceuticals Ltd, Wisdom Pharma (P) Ltd, Nitin Pharmaceuticals P Ltd, MAAN Pharmaceuticals Ltd, Leben Laboratories Pvt Ltd, Sunij Pharma, Speciality Meditech Pvt Ltd, West Coast Pharmaceutical Works Limited, Ciron Drugs, Belco Pharma etc have used fictitious, nonexistent WHO seals, badges or awards in their promotional literature, advertisements, letter heads or websites.

Cyper Pharmaceutical and Sunij Pharma Pvt Ltd, Drugs Control.org, etc have used WHO name and/or logo on their websites.

Not to be left behind are non-medicinal products like Mother’s Horlicks which has wrongly used WHO name in its advertisement campaign and Bombay Chemicals Pvt Ltd which has used WHO logo on its mosquito repellant – Tortoise Ninja.

Dr Thawani told the TOI that while most of the companies using WHO name and logo are of Indian origin, the hall of shame also has giant transnational companies from developed economies. “My counterparts in these countries however tell us that these companies do not do such medicine promotion in their own countries,” remarked Dr Thawani. A part of the study by the researchers has already been published in a journal specifically on WHO name in Oral Rehydration Salts (Are ORS
brands in India using WHO name judiciously? N Bachewar, V Thawani, K Gharpure. Indian Journal of Pharmacology, Dec 2006, 38 (6), 439-441). Dr Vijay Thawani told the TOI that he has received an appreciation letter from Regional Director, World Health Organization, Regional Office for South East Asia (SEARO), New Delhi for safeguarding the integrity of WHO reputation in medicines.

The distribution of the misue of WHO name, logo, seal by pharmaceutical companies was noticed for over 121 companies. So how many companies misued the WHO in which form?

Misuse of logo 17 Fake WHO seal 22 Quoting WHO name for promotion 11 Who-GMP certification 21
Claiming WHO/GMP certification even before commissioning of production 6
All figures are in percentage
WHO name and logo in vaccine production 43 Job offers in WHO/GMP company 16 WHO model list of essential medicines 8
Prequalification promotion in the anem of WHO 8 Promotional statement in the name of WHO 8 WHO nutritional supplement 8
WHO/GMP approved unit wanted 8
All figures are in percentage

Consultancy services admit mistake

Nagpur: Various agencies assuring admissions in foreign medial and dental colleges lure aspirants by claiming in advertisements that these colleges or universities are WHO recognised, which is a lie and also violation of WHO norms.

Most of these advertisers admitted their fault of using the word ‘WHO recognized or certified’ in their advertisements in papers.

Dr Arshi Khan, A K Educaional Consultancy, Sadar said, “Yes, I admit my advertisement has wrongly used the word. Actually we wished to convey the clients that they will be sent to the WHO-listed colleges only in any foreign countries for pursuing any medical degree.”

Said Milind Bire, Mahrashtra Consultant for Medico Abroad agency: “WHO does not recognise any courses or degrees but the WHO name is used only to attract clients’ attention.” Mrunal Patole, manager, A J Trust Education Consultancy, Pune said that the agency’s intention was merely to attract students by using WHO name. But the agency claims it always clarifies all facts to students before sending them abroad.

CEO, Prashant Education Group, Dhantoli, Bobby S Kalsi, refused to talk on the issue. “I will talk only if you come to my office,” he said.

‘Authorities not taking steps to check menace’

Although many officials in the WHO office are aware of the gross misuse of WHO logo, name and certification by the drug industry, no one wishes to speak on record.

“We have brought ample cases to the notice of the Drug Controller General of India (DCGI) as and when they were brought to our notice,” said one of the seniormost WHO officials (medicine branch)from New Delhi. “But unfortunately, the authorities have never taken necessary steps to check the menace.” He said that WHO India cannot go against the central government and it was for the authorities to take necessary action. The official cited a few examples of companies like Yash Pharma, Mumbai, who withdrew the WHO logo from their website in March 2004. Another company warned by WHO was Strides Acrolab Limited which too used WHO name. Repeated requests through e-mail and on telephone to the DGI were not attended to. The DCGI office, in turn, passed the buck on WHO. Interestingly however, the Central Drug Standard Control Organisation (CDSCO), which falls under the purview of DCGI, instead of keeping a check on companies using a WHO Good Manufacturing Practice (GMP) certificate, appears to support the companies. The CDSCO website displays on its website a list of 814 manufacturing units having a WHO GMP certification with a disclaimer at the end of the list which reads, “This information has been compiled on the basis of information made available by the concerned State Drugs Control Authorities who are authorized to issue these certificates under WHO GMP certification Scheme. This office is not responsible for any possible omissions.”

Another WHO official in the essential drugs and other medicine section of WHO, New Delhi said, “It is matter of shame that CDSCO does not even conduct its inspections to check whether the manufacturers are following WHO guidelines and instead issues such list on its site.”

Sources in the WHO Office say that, on its part, the WHO has issued warning letters to some companies on a few occasions. In fact, some companies even withdrew their advertisements but there were others who shifted their premises to newer locations and continue to practise such false propaganda.

WHAT WHO (GENEVA) HAS TO SAY

Dr Kathy Holloway, Medical Officer, Department of Medicines Policy and Standards, WHO Geneva, talking to TOI over the phone said, “Yes, it is a serious issue and sheer violation of WHO norms. It should not happen, and is just unacceptable. But, it is for the Government of India to take action. WHO cannot intervene as only regulatory agencies of member states and regional offices are expected to see that the norms are not violated,” she said.

WHO’S WARNING

As per the report of the 107 session of WHO Executive Board meeting held on November 30, 2000, the WHO warns against any such misuse on page 11 of the report in point 48 titled ‘Use Of WHO’S Name Or Emblem.” It says WHO’s name and emblem are recognised symbols of integrity and of assurance to the public. No commercial enterprise shall be authorised to use WHO name or emblem for the promotion, advertisement or marketing of its products or services. Use of the name or emblem in all other circumstances involving commercial enterprises or trade associations representing commercial enterprises must always be cleared with the Office of the Legal Counsel, in particular when the name or emblem is to be used in conjunction with other names or logos to indicate joint work or ownership. WHO has pointed out that the WHO name is protected and pursuant to resolution (WHA1.33 ) of the first World Health Assembly, the name of WHO may not be used nor may its emblem be reproduced without prior written authorisation of the director-general.