The Narendra Modi government has warned drug manufacturers to strictly adhere to rules while marketing medicines and medical devices, after a report revealed glaring instances of pharma companies bribing doctors.

A report published by the NGO, Support for Advocacy and Training to Health (SATHI) indicated that medical representatives bribe doctors with foreign trips, expensive smartphones and even women. Medical representatives pay for “purchase of cars, international conferences, online shopping vouchers and even female companionship for doctors”, it stated.

At a review meeting on 23rd December, with three drug associations—Indian Drug Manufacturers’ Association (IDMA), Indian Pharmaceutical Alliances (IPA) and Organisation of Pharmaceutical Producers of India (OPPI)—the government questioned them for not complying with the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP).

“Drug manufacturers have been warned to follow the UCPMP voluntarily otherwise, the government will be forced to make it a statutory provision under law. This will restrict their marketing practices and could affect sales,” said a senior official in the Department of Pharmaceuticals (DoP). The official was part of the review meeting, which was chaired by DoP Secretary P.D. Vaghela. The associations, IDMA, IPA and OPPI, represent drug manufacturers such as Johnson & Johnson, Bayer, Astra Zeneca, Sun Pharma, Lupin, Glenmark and Novartis.

New rules for medical devices industry

While IDMA, IPA and OPPI are responsible for reporting complaints to the National Pharmaceuticals Pricing Authority (NPPA) every quarter, about marketing practices and deviations from UCPMP, not a single compliance report has been received since 2014, officials said.

“The associations told us that they haven’t found any non-compliance in the industry, whereas several media reports have highlighted misuse of marketing strategies to lure doctors,” the official quoted earlier said.

The government has also warned drug manufacturers introduce a rule that allows for the suspension of annulment of manufacturing licenses if an instance of unethical practice is reported. “The associations have been asked to not force the ministry to take strict actions, otherwise we will come up with a new law and revoke manufacturing licenses,” the official added. This was confirmed by the drugmakers’ associations.

“Industry has to come forward and ensure a better degree of voluntary compliance,” said Deepnath Roy Chowdhury, president of the Indian Drug Manufacturers Association – a lobby representing over 1,000 top domestic pharmaceutical companies.

The government may also add a separate chapter in the UCPMP for medical devices. “The devices are treated at par with drugs in terms of promotional activities. We have discussed adding another chapter on the rules for devices alone,” added the DoP official quoted above.

What is Uniform Code of Pharmaceuticals Marketing Practices

The UNPMP, released in 2014, is a voluntary code issued by the DoP that is related to the marketing practices of pharmaceutical companies and the medical devices industry. It curbs gifting and sampling of products to healthcare professionals. The code states that each sample pack given to a doctor should be limited to the prescribed dosage for three patients.

The UNPMP also states “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.” Not only for the healthcare professionals, but also none of such gift should be extended to a doctor’s family members (both immediate and extended). It also says “companies or their associations shall not extend any travel facility inside the country or outside including rail, air, ship, cruise tickets, paid vacations, etc. to healthcare professionals and their family members for vacation or for attending press conferences”.

What the SATHI report said

A report by the NGO, Support for Advocacy and Training to Health (SATHI) disclosed that “the ethics and values which were followed in the past are getting bypassed” and “often these codes are not adhered, to achieve business”. It stated that tactics like an inducement, emotional appeals, persuasions, serving family members, sponsorships for national and promotional and marketing practices of the international conferences, pampering pharma industry and the implementation doctors, etc are used as the norm.

The study based on the responses of medical representatives (MRs) found “Some doctors who give huge business demand women for entertainment and these demands are met”. “Such arrangements are done by a senior level management, and MRs are not directly involved, and is reserved only for the doctors who give enormous business.”

The study also reported that “in many deals involving high value offers such as installment on the purchase of a car; the company threatens the doctor of dire consequences if the targeted business is not achieved”.

Source: The Print