The rejection is a setback for public health groups that have been pushing for rules on marketing to curb bribery and corruption
India’s plan to bring in marketing rules to curb unethical promotional practices in the country’s drug industry faces an indefinite delay after it hit a legalroadblock, marking a setback for public health groups.
Ministry of Law and Justice has rejected draft marketing rules, which were prepared by the Department of Pharmaceuticals (DoP) after nearly two years of deliberations. According to industry sources, the rules cannot be passed under the proposed legal framework.
DoP officials did not respond to requests for comment, and GN Raju, Secretary, Ministry of Law and Justice, declined to comment beyond saying that the ministry had responded to the DoP on the draft weeks ago.
The rejection is a setback for public health groups that have been pushing for rules on marketing to curb bribery and corruption, which many doctors and medical professionals say is rampant in India’s health sector.
A draft of the rules was sent to the Ministry of Law and Justice earlier this year. Sources, who declined to be named, said the Ministry of Law and Justice has returned that draft saying it cannot be passed under the Essential Commodities Act of 1955.
The DoP is now likely to go back to the drawing board and make new rules using a different legal framework, lawyers and health activists tracking developments on this topic said.
DG Shah, Secretary General, Indian Pharmaceutical Alliance, which represents 20 of the country’s biggest drugmakers, said he expected the DoP to address the objections raised by the law ministry and modify the rules. The rejection did not come as a surprise to some.