From three years between 2016 and 2018, the Centre was open to making the UCPMP mandatory but changed track in 2019 in a reply to the Rajya. Then in 2020 (September 18) Minister for Chemical and Fertilizers Sadananda Gowda reiterated the same in the Rajya Sabha even while admitting how toothless it was. He said: “The Uniform Code for Pharmaceutical Marketing Practices (UCPMP) is voluntary in nature and under UCPMP, there is no provision for Department of Pharmaceuticals to directly deal with complaints received regarding unethical practices.”

What was the new discovery that led to the change in stand?

That is not known. What is known is that several new facts came to public domain showing that marketing malpractices continues, pointing to the code’s ineffectiveness.

For example, in February 2019, the DoP had revealed in a response to a RTI query that it had received complaints of “bribing doctors, medical shopkeepers and unauthorized medical practitioners to sell their pharmaceutical products” in 2016 against 20 pharma companies (names identified) – which included some of the big and famous ones. What action did the DoP take? The reply said the DoP had forwarded the complaints to the Ministry of Health and Family Welfare (MoHFW), the Medical Council of India (MCI) and a pharma association (not named). What action did the MoHFW or MCI took? The DoP didn’t reveal.

In December 2019, more dirt flew. An NGO, Support for Advocacy and Training to Health (SATHI), alleged that medical representatives had paid for “purchase of cars, international conferences, online shopping vouchers and even female companionship for doctors”. Following this, three drug makers’ associations, including the IPA, were pulled up by the government.

In January 2020, the Prime Minister reportedly met top drugmakers and warned them about bringing in a law to control malpractices and indicated that the Ministry of Chemicals and Fertilizers (under which the DoP works) had been asked work on the law.

Following this, the Indian Medical Association (IMA), the largest body of medical doctors, wrote to the Prime Minister seeking an explanation as to why pharma companies were invited to the PMO for talk, instead of initiating criminal proceedings if it had details of the bribery by the companies.

In the meanwhile, revealing more contradictions, the Centre’s affidavit of October 4, 2022 to the Supreme Court made two more disclosures: (i) It had initiated a study in October 2021 “to evaluate the necessity and measure of making the code statutory”, but this study couldn’t take off and (ii) it set up a High-Level Committee (HCL) on September 12, 2022, under NITI Aayog member V K Paul, to examine the entire issue of marketing malpractices and to find “legally enforceable mechanism”. The HCL has been given 90 days to submit its report and one of its members happens to be CBDT chairman Nitin Gupta.

So, why did the Centre rule out a legal status in its affidavit and cite several other mechanisms –Indian Medical Council (Professional Conduct & Ethics) Regulations of 2002 (under the Indian Medical Council Act of 1956), Drugs and Cosmetics Act of 1940 and Prevention of Corruption Act of 1988 – to claim that the existing mechanisms are “robust and effective”?

That is not clear.

Here is another shocking revelation, from the US, which is pertinent to the Dolo-650 matter.

Drugs aren’t costlier due to R&D or curative values

On September 26, 2020, a first known study of its kind was published about the US pharma world. An international team of researchers from top universities evaluated if high R&D explained high drug prices in the U.S. – since drug companies often claim so to charge high prices. They studied 60 new drugs approved by the US Food and Drug Administration between 2009 to 2018, and found no such association between R&D expenses and high prices.

This study also found that even curative value of drugs had nothing to do with high pricing. It said it found “no association between the clinical benefit of a new product and prices” – that is, the pricing of drugs is not determined by their corresponding curative or therapeutic value (clinical benefit as proxy for therapeutical value).

It also added that this finding (disconnect between curative value and pricing) “is in line with results from a previous study of cancer therapies”.

The University of California highlighted this study a few days in a paper published three days later (September 29, 2022), which provided some easily relatable facts regarding high drug pricing and R&D. This paper said: “The pharmaceutical industry spent $83 billion on R&D in 2019, according to the Congressional Budget Office. Companies are estimated to spend somewhere between $1 billion and $3 billion on average to bring a single new product to market. In 2019, the US drug market generated more than $490 billion in revenue…”

That is, a revenue of over $490 billion in 2019, from an R&D spend of $83 billion!

The paper went to add: “Americans spend more on prescription drugs per capita than citizens in any other country. In 2019, that worked out to more than $1,200 per person. A 2021 Rand Corporation study found U.S. drug prices were 2.56 times higher than those in 32 comparable countries.”

Now you know why pharma companies need a tight leash.

Dolo tablet

Dolo-650 bribery allegation: Why pharma cos need tight monitoring