India’s Department of Pharmaceuticals released a 14-page “voluntary code” for drug marketers, which includes a strict ban on gifts to prescribers, among other things.
The code, which is open for public comment until June 30th, states that “no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe” a drug. Additionally, “gifts for the personal benefit of healthcare professionals (such as tickets to entertainment events) also are not [to] be offered or provided,” the code states.
However, some concessions are made for continuing medical education (CME). For example, pharma companies may provide monetary assistance covering “actual travel expenses, meals, refreshments, accommodation and registration fees” for physicians, but the events and expenses “have to be organized in India only…and incurred only for the events held in India.” Assistance funds are not to be extended to “spouses or other accompanying persons” hoping to travel to CME events, and companies are barred from organizing meetings that “coincide with sporting, entertainment or other leisure events or activities.”
On his MedCom Strategies blog, Dr. Neelesh Bhandari, a New Delhi-based medical communications consultant, took issue with the rule about meetings coinciding with other events. “This is a totally uncalled for limitation. Why shouldn’t healthcare professionals attend meetings because of the IPL [Indian Premier League] being held at the same time?” wrote Bhandari. The IPL is a professional cricket league.
Other proposed rules in the code limit drug sampling “to prescribed dosages for three patients,” and sample packs “shall not be larger than the smallest pack presented in the market.” Providing samples of “anti-depressant, hypnotic, sedative or tranquillizer” drugs in any amount or packaging unit is disallowed, under the proposed code.
Regarding textual and audio-visual promotional material, marketers are prohibited from using the “names or photographs of healthcare professionals.” Marketers are also asked to avoid “extremes of format, size or cost of promotional material.” On his blog, Bhandari wondered if that rule would “limit the size and costs in pharma marketing projects.” Audio-visual material “must be accompanied by all appropriate printed material” as well, prompting Bhandari to suggest that “this could kill digital pharma marketing in India.”
The full document and code is available here. The regulations are voluntary for now, but “its implementation will be reviewed after a period of six months form the date of its coming into force, and if it is found that it has not been implemented effectively…the government would consider making it a statutory code,” the document says. The Department of Pharmaceuticals is a division of India’s Ministry of Chemicals and Fertilizers.