New Delhi: The Narendra Modi government has warned drugmakers to strictly adhere to rules while marketing medicines and medical devices, after a report revealed glaring instances of pharma companies bribing doctors, ThePrint has learnt.
The report, published by NGO Support for Advocacy and Training to Health (SATHI), suggested that medical representatives bribe doctors with foreign trips, expensive smartphones and even women. Medical representatives have paid for “purchase of cars, international conferences, online shopping vouchers and even female companionship for doctors”, it stated.
At a review meeting on 23 December with three drugmaker associations — Indian Drug Manufacturers’ Association (IDMA), Indian Pharmaceutical Alliances (IPA) and Organisation of Pharmaceutical Producers of India (OPPI) — the government pulled them up for not complying with the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP).
“Drugmakers have been warned to follow UCPMP voluntarily or else the government will be forced to make it a statutory provision under the law. This will restrict marketing practices of drugmakers and 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 drugmakers 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 drugmakers to come up with a rule to revoke manufacturing licences if any 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 licences,” the official added.
The drugmakers’ associations confirmed this.
“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 UCPMP, released in 2014, is a voluntary code issued by the DoP and related to marketing practices for 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 UCPMP also says “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 healthcare professionals, but no gifts should also 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
The report by SATHI found 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 said 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 a norm.
“Some doctors who give huge business demand women for entertainment and these demands are met,” the study based on the responses of medical representatives (MRs) found. “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.”
MRs are those who pitch the products directly to the doctor.
The study also found 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”.