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'DNA' investigations: With no laws, pharma firms have a field day

Friday, 28 December 2012 - 4:43am IST | Place: Mumbai | Agency: dna

In the absence of any penal provisions, pharma companies brazenly offer incentives to doctors, flouting the Department of Pharmaceuticals’ ‘voluntary code’.

In the absence of any penal provisions that may be applied in cases where pharmaceutical majors use unethical practices to woo doctors to promote drugs, pharma companies brazenly offer incentives to doctors, flouting the Department of Pharmaceuticals’ ‘voluntary code’.

As a result, while a December 2009 code of medical ethics developed by the Medical Council of India (MCI) includes legal provisions to punish doctors who accept gifts from pharmaceutical companies in return for aggressively prescribing certain drugs, there is nothing to stop drug manufacturers’ unethical practices.

Santhosh M R of the Centre for Trade and Development (CENTAD), an organisation that conducted a study on pharmaceutical companies on behalf of the Competition Commission of India (CCI), says, “In the absence of any legal provision, no company can be prosecuted (for such activities). Thus, they are fearless.” On Thursday, DNA reported that the country’s top pharma firms routinely offer considerations ranging from gifts including electronics and gold coins to foreign trips to doctors who achieve pre-fixed targets for prescriptions of certain drugs.

The 58th report of the Parliamentary Standing Committee on Health and Family Welfare dated May 8, 2012 says there appears to be little logic in keeping the code for companies a voluntary one. “The Committee has been given to understand that the voluntary code has generally not been successful in curbing unethical practices and off-label promotion of drugs,” the report says, adding that the Secretary (Pharmaceuticals) was unable to offer any valid reason for not making the uniform code a statutory provision.

A statement to DNA from the World Health Organization also opined that implementation of the code must be reviewed. “If it is found that it has not been voluntarily and effectively implemented by pharmaceutical associations/ companies, the government should consider making it a statutory or binding regulation,” the WHO said.  

Also worrying is that companies keep the working and service conditions of medical representatives, the footsoldiers who meet doctors and promote  drugs, highly suspect.

While the Sales Promotion Employee (Conditions and Services) Act, 1976 empowers medical representatives and regulates their service conditions, the Federation of Medical & Sales Representatives’ Association of India (FMRAI) which represents more than 1.5 lakh medical representatives, says almost no pharma firm issues legally amended appointment letters as stipulated by the Act. “If they give appointments under Form A, they would be bound by the Act and all the labour laws would prevail. In such a scenario, the employees will have a stronger say and can refuse to participate in unethical practices,” said JS Majumdar, former general secretary of the association.

“This in turn would mean that they would be forced to undertake unethical practices.Even if they are caught, the blame would come on representatives and doctors,” Santhosh added. 

Several appointment letters of sales promotion employees accessed by DNA show that they are recruited as territory business managers, product executive and product specialists, etc. In fact, when the issue was brought to the notice of the central government in August 2010, KM Gupta, economic advisor to the Centre’s labour department, sent a letter to labour secretaries of all states advising imprisonment as a penalty for employers who violate the provisions of the Act. 

The FMRAI also gave a memorandum to the Labour Minister, Government of Mahrashtra, in February 2012 regarding the violation of the law by pharma companies.

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