The Narendra Modi government, in an attempt to curb unethical practices, has made the new marketing code for pharma companies mandatory, breaking away from the previous voluntary status.
The Department of Pharmaceuticals on Tuesday announced a new regulation barring pharmaceutical companies from providing gifts, travel perks and many other benefits to doctors or their families. The marketing code known as the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) defines the relationship of pharmaceutical companies with doctors.
With the entire process now under government lens, a new era of accountability and transparency is set to dawn upon the pharmaceutical industry, a top officer of the Modi government told News18.
“It is not voluntary any more. It is mandatory. The entire process will be under government oversight. Now, any government agency or authority can be brought in as per statutes and as relevant to the context,” Arunish Chawla, secretary, Department of Pharmaceuticals, told News18.
The department falls under the Ministry of Chemicals and Fertilisers and is responsible for making and executing policies for the regulation of pharmaceuticals in India.
Chawla quoted the line from the code which falls under the subhead of penalties and references to indicate the role of the new and crucial role of government in keeping the code intact.
“In cases where disciplinary, penal, or remedial action lies within the domain of any agency or authority of the Government in accordance with the statute, the Committee may send its recommendations to such agency or authority through the Department of Pharmaceuticals,” read the code.
The move to strengthen UCPMP was started by Prime Minister Narendra Modi in 2019 when he warned India’s top pharmaceutical companies to strictly adhere to marketing ethics and not bribe doctors.
The catalyst for this action was a report released by the NGO Support for Advocacy and Training to Health (SATHI), indicating that medical representatives (MRs), who directly promote products to doctors, offer bribes such as overseas trips, high-end smartphones and gadgets.
Record-keeping is key
From restricting the supply of free samples of drugs to only those who can prescribe the product to restricting the use of names or photographs of healthcare professionals on promotional material — the nine-page long code covers all important aspects of marketing and promotions. Overall, the code mandates record-keeping for the majority of the activities performed by pharma companies.
According to the new rules, samples of products must be distributed by a medical representative and the sample must be handed directly to the person qualified to prescribe such product, or to a person authorised to receive the sample on their behalf.
“The name and address of the healthcare practitioner must be noted for records.”
The new code also clarified that companies are responsible for the activities of their employees, including the medical representatives, for ensuring compliance. “This should additionally be ensured through an appropriate clause in the employment contract signed between the Company and its Medical Representatives…,” the code said.
While the code allows the use of “Continuing Medical Education” or CME by pharma companies, it tries to bring transparency by bringing a more verifiable set of guidelines.
Firstly, the code bars conducting CMEs at international locations. CMEs were known as one of the most convenient ways for bribing doctors with international trips. “Conduct of such events in foreign locations is prohibited,” the code said.
Now, such meetings are allowed to be conducted at domestic places such as medical colleges, teaching institutions, universities, hospitals, pharma colleges and other academic and research institutions.
Moreover, the code says that “all pharmaceutical companies should share the details of such events conducted by them, including the expenditures incurred thereupon, on their website, and may be subject to independent, random, or risk-based audit for this purpose”.
Code defines pharma-doctor relationship
The code states that “no gift should be offered or provided for personal benefit of any healthcare professional or family member by any pharmaceutical company or its agent.”
By agent, it means, distributors, wholesalers, retailers and others. Also, pharma companies or their representatives should not extend travel facilities – inside or outside the country including paid vacations – to healthcare professionals or their family members for attending conferences, seminars, and workshops.
However, a travel facility can only be provided when the person is a speaker for a CME program or event.
Similarly, companies cannot extend hospitality like hotel stays, expensive cuisine, or resort accommodation to doctors or their family members unless the person is a speaker.
Establish committees
All the Indian pharmaceutical associations have been asked to upload the UCPMP on their website along with the detailed procedure for lodging complaints which will be linked to the UCPMP portal of the Department of Pharmaceuticals.
There will be a committee for handling complaints named as “Ethics Committee for Pharma Marketing Practices (ECPMP)” in each association, chaired by its Chief Executive Officer (CEO).
“The Committee will have three to five members, and its composition will be approved by the Board of the Association and prominently placed on its website,” said the code.
News18 reached out to several industry experts and veterans. However, they were yet to fully understand the implications. “More or less, the code is on the expected lines,” an industry veteran representing a top pharma lobby said.
Another industry expert said while the code is not very strict but good enough to bring transparency, he was surprised to know that the code has been made mandatory.
“The government was bringing balance in the industry and clarity in the relationship between doctors and pharma companies. The code does the same. However, it’s surprising that this code has been made mandatory.”
The UCPMP, released in 2014, was a voluntary code related to marketing practices for pharmaceutical companies and the medical devices industry. It stops pharma firms from gifting sample products to healthcare professionals. The code states that each sample pack given to a doctor should be limited to the prescribed dosage for three patients.
