New Delhi: A revised final draft of a code regulating promotional practices in the pharmaceuticals industry, such as offering gifts to medical professionals, has been sent to the law ministry for vetting, two people familiar with the matter said, indicating that the code could soon be enforced.
The government’s plan to bring in a code to curb unethical promotional practices had hit a roadblock in August after the law ministry sent back an earlier draft to the department of pharmaceuticals (DoP), saying that the “power of imposing financial penalties with regard to the offence was not aligned with the legal framework of the Essential Commodities (EC) Act.”
The pharmaceuticals department of the chemicals and fertilizers ministry has sent a revised final draft of a code to the law ministry for vetting, the people mentioned above said on condition of anonymity.
The law ministry had also sought a clarification on whether the proposed Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) was similar to the professional conduct, etiquette and ethics code of the Indian Medical Council, which doctors must follow in their relationship with pharmaceutical and allied health services firms.
The law ministry also said some of the provisions of the EC Act were not strictly covered and suggested that the proposal may be brought under the ambit of the Drug Price Control Order (DPCO), the people cited above said.
However, ruling out the possibility of the code being brought out as a new law or under DPCO, the people cited above maintained that the proposal would be promulgated under the EC Act and the draft was sent for final clearance to the law ministry early this month, without any changes in the quantum of penalties.
According to the draft, a company will be penalised if it is found violating the Code. As anticipated, the draft UCPMP has no provision for arresting a company’s chief executive for violations.
“There are provisions of penalties only in lieu of confiscation of drugs of the company, found in violation of the proposed act,” said one of the persons cited above.
The EC Act, 1955, gives powers to the government to control production, supply, distribution, etc. of essential commodities for maintaining or increasing supplies and for securing their equitable distribution and availability at fair prices. This includes foodstuff, drugs, fuel (petroleum products) et cetera.
The draft, aimed at increasing transparency in financial relationships between healthcare providers and pharmaceutical manufacturers as well as deterring unethical practices, has been pending for more than two years.
According to the UCPMP, 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.
Gifts for the personal benefit of healthcare professionals and family members, both immediate and extended, such as tickets to entertainment events, are also not to be offered or provided.
While the government had in 2011 come out with the voluntary marketing code and its amended version in 2015 following complaints of unethical marketing practices, like bribing doctors and pharmacists through foreign junkets, gifts and other incentives. The voluntary code failed to deter unethical practices.
“It was left on the industry to implement it. However, the need for mandatory code with penal provisions was felt due to its poor compliance. The DoP thereafter decided to make it mandatory giving more teeth by adding penal provisions,” said a person from a pharma lobby group.
Expressing concern over DoP decision to bring UCPMP under Essential Commodities Act, D.G. Shah, Secretary General, Indian Pharmaceutical Alliance, said that “the proposed law should not be under the EC Act. EC Act is meant for essential commodities and here we are talking about services. There is no provision under the EC Act to cover services. This will unnecessarily force the industry to go to court and litigations will continue for a long time. If they want effective implementation it should come under the Drugs and Cosmetics Act.”