Existing pharma marketing practices code is adequate: Centre tells SC

Says Indian Pharmaceutical Alliance's investigation report cleared Dolo-650 maker, Micro Labs, of allegations of bribing doctors with freebies worth Rs 1,000 crore

The Centre has defended the Universal Code of Pharmaceutical Marketing Practices (UCPMP) in the country’s apex court, saying that the existing framework to monitor marketing practices of drug firms is working fine.

N Yuvraj, joint secretary, Department of Pharmaceuticals, said in a submission to the Supreme Court that the Indian Pharmaceutical Alliance’s (IPA) investigation report cleared Dolo-650 maker, Micro Labs, of allegations of bribing doctors with freebies worth Rs 1,000 crore.

The IPA, whose members account for 60 per cent of India’s domestic pharmaceutical market and about 80 per cent of India’s exports, has said in an investigation report submitted to the National Pharmaceutical Pricing Authority (NPPA) that “In view of interaction with the management of the company and the detailed reply, it is clear that Rs 1,000 crore expenditure on single brand Dolo-650 on freebies in one year is not correct.” The national pricing regulator had asked the IPA to investigate the matter under the Uniform Code of Pharmaceutical Marketing Practices (UCPMP). A three-member internal committee examined the issue.

In its submission the Centre said that the petition by the Federation of Medical and Sales Representatives Associations of India (FMRAI) gives ‘incorrect impression that the extant legal regime is insufficient and inadequate to protect the citizens from unethical marketing practices by pharmaceutical companies’.

Business Standard has a copy of the document.

The Centre has cited the IPA investigation to say that it shows that the UCPMP works adequately. The DoP and the NPPA have reviewed implementation of the voluntary code in various instances, it added.

It also cited the Indian Medical Council Professional Conduct, Etiquette and Ethics Regulations, 2002 under the Indian Medical Council Act, 1956, that it prevents a physician or medical practitioner to commit unethical acts in their relationship with the pharmaceutical industry which includes taking gifts, travel facilities, hospitality, cash, etc.

In fact, the NPPA has prepared a proforma for furnishing a quarterly return on complaints received and action taken by industries association (as per para 8 of the UCPMP), the Centre said.

The FMRAI had filed a plea with the SC seeking direction to the government to give the UCMCP (Code) statutory basis and making it effective by ensuring a monitoring mechanism, transparency, accountability as well as consequences for violations. It moved court in August.

In response, in September the government formed a five-member committee led by V K Paul, member (health) of NITI Aayog, to consider a "legally enforceable" mechanism for regulating the marketing practices of pharmaceutical firms.

The committee will submit its report in 90 days. S Aparna, secretary in department of pharmaceuticals (DoP); Rajesh Bhushan, secretary in the Ministry of Health and Family Welfare (MoHFW); Nitin Gupta, chairman of the Central Board of Direct Taxes (CBDT); and a joint secretary (policy) from the department of personnel (DoP) are the four other members of the 'high level' committee. Paul will be its chairperson.

The committee may bring in members from the law department if required, the memorandum said. It will examine the provisions government departments have to regulate pharmaceutical marketing practices and align interventions for implementation by the healthcare industry.

Ramesh Sundar, president of the Federation of Medical & Sales Representatives Association of India, told 'Business Standard' that the government is dragging its feet in implementing the UCPMP, which codifies the dos and don'ts for promoting drugs and the role of medical representatives.

Civil society groups want a statutory UCPMP. Malini Aisola, co-convenor of All India Drugs Action Network (AIDAN), has called for reforming the Medical Council of India’s code and rejected self-regulation by industry groups like the Indian Pharmaceutical Alliance.

“Firms should disclose publicly how much ‘fees’ they have paid to which healthcare professional for which ‘service’ and this should be made public from time to time. This one step would largely discourage firms from engaging in malpractices,” Aisola said.

The FMRAI will submit its response to the SC after studying the Centre’s response.