Govt extends deadline for pharma co. bosses to submit unethical marketing practices undertaking till 31 July

New Delhi: The central government has extended the deadline for pharma and medical device company bosses to file their legal self-declarations assuring the government that they will not indulge in unethical marketing practices to promote their drugs. 

These companies can now file the self-declaration undertaking till 31 July 2024, wherein top executives from these firms must assure the government that they will not engage in unethical marketing practices.

These undertakings are required to be filed for FY25 under the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2024.

Given the inability of some drug and medical device makers to meet the set deadline, some of them had requested the department of pharmaceuticals (DoP) to extend the deadline. 

Consequently, the extension comes as a relief for these firms, as failure to meet the requirements would have invited action from the government.

Also read: Govt seeks nodal officer details to check marketing practices of pharma firms

“With reference to this Department's Circular dated 28th May 2024 made under Uniform Code for Pharmaceutical Marketing Practices (UCPMP)-2024, it is informed that the time for submitting the Self-declaration under UCPMP-2024 has been further extended till 31.07.2024,” stated the DoP's communication to pharma associations, which was also seen by Mint.

Queries sent to the department of pharmaceutical remained unanswered till press time.

Not the first time

These requirements were brought in by the government after Micro Labs—the makers of Dolo 650 mg—was allegedly found to be offering freebies to doctors during Covid-19 pandemic to prescribe its anti-fever medicine.

The UCPMP was rolled out in March 2024 with an objective to bring transparency and ensure ethical conduct by pharmaceutical and medical device making companies in their marketing practices. 

It also restricted them from offering freebies such as gifts, travel, hospitality and monetary benefits to the doctors for prescribing a particular medicine.

Not filing the declarations in time or adhering to other norms set out under the code would allow the government to take action against these companies.

Also read: Government to audit pharma companies in July to review compliance with GMP norms

While the code bars pharma firms from giving free samples of drugs to any person who is not qualified to prescribe them, the code also regulates events, seminars and workshops involving the pharmaceutical industry and doctors. 

The UCPMP further requires these events to be organised in a well-defined and transparent manner, by disclosing the details and expenditure incurred to host them.

A holistic approach

According to government data, India is home to approximately 3,000 drug making companies and 10,500 manufacturing units. 

Moreover, the drug manufacturing industry in the country is projected to reach a value of $130 billion by 2030, from $50 billion currently. It is expected to reach $65 billion by the end of 2024.

Also read: Centre asks states to tackle over-the-counter sale of prescription drugs

Earlier, Mint had reported that the DoP has instructed all the pharma associations—such as Indian Drugs Manufacturing Association (IDMA), Indian Pharmaceuatical Alliance (IPA) and others—to nominate nodal officers from each of their member firms to deal with matters related to the UCPMP. 

The ethics officer would also be tasked with monitoring the marketing practices of their companies.