Proposed rules which would limit the amount pharma companies could spend on gifts and trips for doctors have been rejected by India’s legal ministry. This was after a draft was submitted by the Department of Pharmaceuticals (DoP), that the ministry said could not be implemented with “the proposed legal framework” as it would conflict with the Essential Commodities Act of 1955. This is according to a Reuters report, drawing on anonymous industry sources.
The proposed marketing restriction rules were announced at the beginning of August in a bid to curb bribery and corruption in some areas of Indian healthcare. The practice, employed by some pharmaceutical companies, of bribing doctors with expensive gifts, trips and cash payments has the potential to both endanger patients and erode the doctor-patient relationship. It has resulted in what the Times of India calls “an entrenched conflict of interest in Indian healthcare.”
The proposed marketing rules would build on pre-existing legislation – namely the Uniform Code of Pharmaceutical Marketing (UCPM), which was introduced in 2015 as a voluntary code of ethics. The UCPM was supposed to become mandatory after six months, but this has yet to happen due to a number of legal extensions being granted against it.
The new rejection of pharma marketing could present a similar setback, as it forces the DoP to “go back to the drawing board and make new rules using a different legal framework.”
Concerns are being expressed that the rejection could lead to an “indefinite delay” in terms of the marketing restrictions being enforced. Malini Aisola, a member of the All India Drug Action Network, says “we are worried [the rules] will not see the light of day.”