Pharma marketing rules hit Legal roadblock

The Pharma Marketing rules that are proposed by India has hit the legal a legal road block. The pharma marketing rules were mainly focused on avoiding the unethical promotional practices in the country. There is an indefinite delay in setting these rules hampering the country’s drug industry and public health.

The draft marketing rules have been rejected by the law ministry. These draft marketing rules were prepared by the Department of Pharmaceuticals (DoP) after two years of strenuous work on the same. The law ministry has said that these rules cannot be passed under the proposed legal framework of the country, as reported by the industry sources to Reuters.

G.N. Raju, Secretary at the law ministry’s legislative department has also declined to comment beyond saying that the ministry has responded to the DoP on the draft weeks ago. This rejection has badly affected the public health groups that were expecting these rules to be passed to curb bribery and corruption from Pharma Industry.

According to most of the medical professionals and doctors, bribery and corruption are rampant in India’s health sector. Being one of the biggest drug markets with a population more than 1 billion and constant rise in the communicable and non-communicable diseases, there is need to impose such rules to ensure the complete treatment of diseases with ease.

As the country has no rules for the marketing of pharmaceutical products, activist has investigated several cases of drugmakers offering huge incentives to the doctors and pharmacists for marketing their products.  As an initial response, DoP has issued a voluntary marketing code in 2011 and an amended version in the yeat 2015.

After considering the complaints of the non-compliance with the code from People’s Health Movement, the Department of Pharmaceuticals set out to make certain rules mandatory.  A draft of rules was sent to law ministry earlier this year. Industry sources said that the law ministry has returned the draft saying it cannot be passed under the Essential Commodities Act of 1955.

The lawyers and health activists tracking the development of this issues has said that the DoP is now likely to revise and make new rules using a different legal framework.

Indian Pharmaceutical Alliance, Secretary general, D.G. Shah said that he expected the Department of Pharmaceuticals to address these objections raised by the law ministry and modify the rules as per the legal framework.

This rejection and indefinite delay do not come as a surprise to many.


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