The Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) — the mandatory code that aims to regulate unethical promotional practices in the pharmaceuticals industry — may not see the light of the day anytime soon as it has run into “legal issues”.
“There was a draft code, and then there were some legal issues, we are still trying to cross the hurdles,” said Sudhansh Pant, Joint Secretary of DoP in Mumbai.
Pant declined to provide any timeline as to when the UCPMP will be implemented but said the UCPMP would still be under the ambit of Essential Commodities Act, 1955 ruling out of the speculations that it could be brought out as a new law.
The Law Ministry, which was vetting UCPMP, asked the DoP to rework on the draft code as it wasn’t aligned with the legal framework of Essential Commodities Act.
The Essential Commodities Act is invoked in cases of hoarding or black marketing of foodstuff, drugs, and fuel affecting the normal life of people.
The government in response to the complaints of unethical marketing practices, such as miss-selling, bribing doctors and pharmacists through foreign junkets, gifts and other incentives, has come out with a voluntary marketing ‘code’ in 2011, and an amended version in January 2015.
The voluntary marketing code was left for the industry bodies to implement, however, it failed to deter the unethical practices forcing the government to come out with a mandatory code giving it a statutory backing and penal provisions.
The UCPMP, among other things, prohibit pharmaceutical companies from providing any gifts, monetary advantages, and benefits in kind to physicians to prescribe drugs.
Further, pharmaceutical companies or their associations are not allowed to extend any hospitality like hotel accommodation to healthcare practitioners and their family members under any pretext. And the companies should not provide free samples of drugs to any person, not qualified to prescribe such product.
As per the new code, the Managing Director or the Chief Executive Officer of the company will be responsible for ensuring adherence to the Code.
Industry bodies, while welcoming UCPMP, say that DoP acted in haste by bringing UCPMP under the ambit of draconian Essential Commodities Act instead of a separate law.
“OPPI believes that mandatory implementation of UCPMP will increase accountability and ensure high ethical standards for the pharmaceutical industry,” said Sharad Tyagi, Chair-OPPI Compliance and Governance Work Group & Managing Director – Boehringer Ingelheim India.
“However, the Essential Commodities Act, 1955 is meant to specifically control production, supply & distribution of essential commodities and not for regulating ethical standards — for making UCPMP mandatory and ensuring its effective implementation, the legislation must be a sui generis one and must not be supplanted with other legislations,” Tyagi said.
DG Shah, Secretary General of Indian Pharmaceutical Alliance (IPA) that represent large drug makers is of the view that the UCPMP under the current form may create a fear psychosis in the industry.
Instead of panel or committee, it gives one joint secretary level bureaucrat arbitrary powers on compounding penalties.
Even CEO of a company can be arrested on complaints without any recourse or appeal, Shah said.
Shah called on the government to come out with separate legislation or bring it under the ambit the Drugs and Cosmetics Act.
“The best deterrent would be mandatory disclosures from both pharmaceutical companies and doctors in line with the Sunshine Act of US,” Shah said.
“For that, we need to have more integrated approach rather than bringing laws in silos,” Shah added.
The US has enacted the Physician Payments Sunshine Act of in 2010 to increase transparency of financial relationships between healthcare providers and pharmaceutical manufacturers.
Analysts say the legal hurdles of UCPMP are a classic case of one-upmanship going on between various ministries and departments.