From cutting down on the prices of essential drugs to promoting indigenous production and research, Prime Minister Narendra Modi’s efforts are the hallmark to bring down the cost of medical care for the common man.
Modi does think big and thinks differently when it comes to areas like health.
He drew lessons from the pandemic which was a natural disaster affecting countries across continents. Despite several challenges, India developed its Covid vaccine, shared it with others and ran the world’s largest vaccination programme.
On Modi’s directives, officials have now been working to cut trade margins of key diabetic and cardiac medicines.
Trade margin is variation in the price for manufacturers and the price to patients as the maximum retail price (MRP). As the media reports suggest, nearly 106 formulations, including 60 cardiac and hypertension medicines and anti-diabetic drugs
will be covered. It is likely to impact more than 5,000 brands of medicines. Officials indicate that the list covers formulations starting from 1mg to more than 1000mg capsules or tablets.
However, even as mega ideas are in the pipeline, the government faces a fresh challenge in terms of the nexus between some pharma firms and some health professionals.
Take for example, what has come to light in the wake of an income tax raid on a firm and the hearing of a petition in the Supreme Court.
During the pandemic, all of us got familiar with a drug called Dolo-650. It was prescribed for reducing fever and pain.
But new facts show that the drug was given to us possibly in higher dosages because of its manufacturer’s market strategy.
Instead of taking paracetamol of 500 mg (milligrams) three times a day during the COVID-19 pandemic, we may have taken the paracetamol of 650 mg.
A petition before the Supreme Court has brought to light this practice, exposing the rampant malpractice in the pharma industry. The reason: the market price of any tablet up to 500 mg is regulated under the price control mechanism of the government. But the price of the drug above 500 mg can be fixed by a pharma company.
A Bengaluru-based firm, Micro Labs, is accused of exploiting a lacuna in the rules to make money by “bribing doctors” to prescribe its 650-mg Dolo tablets!
And, doctors ignored the side effects of an overdose of paracetamol on the liver and kidney.
On August 18, when the matter came up before the Supreme Court, a bench consisting of Justices D Y Chandrachud and A S Bopanna described it as a very serious issue, affecting the health of the people.
It was noted that the bribery would not have come into sharp focus if the Income Tax department had not conducted raids at 36 premises of the drug maker Micro Labs on July 6. After the raids, the Central Board of Direct Taxes (CBDT) assessed that the makers of the Dolo-650 tablet indulged in “unethical practices” by distributing freebies worth about Rs 1,000 crore to doctors and medical professionals in exchange for promoting products made by it.
It was this disclosure that prompted the Federation of Medical and Sales Representatives Association of India (FMRAI) to file the petition in the Supreme Court, seeking direction for curbing widespread corruption in the industry. FMRAI is a trade union body for medical representatives. Of course, an ethics code has been in place since October 2016 that makes it mandatory for doctors to prescribe only generic drugs to patients.
But the code is violated without any fear by everyone. As doctors can’t receive any cash or gifts, pharma firms give out inducements and benefits.
The Supreme Court has asked additional solicitor general KM Nataraj to file the Central government’s reply to the plea by the petitioner in 10 days. It listed the matter for further hearing on September 29.
The apex Court’s intervention is likely to have far-reaching implications. It may be the beginning of curbing the drug manufacturer-doctor nexus. The petitioners have sought a statutory code of ethical marketing for the pharmaceutical industry.
A few months ago, the Supreme Court observed that giving gifts to doctors by pharmaceutical companies (to promote the sale of drugs) is ‘expressly prohibited by law.’ The Central government too came with an amendment in Section 37(1) of the Income Tax Act. Freebies/expenses by the pharma companies that violate the Indian Medical Council ethics were made not eligible for deduction incurred by them while computing their business income.
However, many tax experts feel that the amendment is a very small step to cleaning up the bad practices in the healthcare system.
There is very little regulation or checks on malpractices in India. In the last 10 years, only a few doctors were debarred from their medical practice. It is alleged that doctors are influenced through freebies that can vary from cash to expensive gifts, foreign trips and other incentives. Doctors end up prescribing drugs from certain manufacturers. At times, doctors prescribe drugs that may not be required, putting an additional burden on patients and their families. Often, such combinations in the prescription are not essential.
Earlier, the government had proposed implementing the Uniform Code for Pharmaceuticals Marketing Practices in 2015, which was then called voluntary, after many protests. The code was to be implemented for six months, after which it was to become a legal provision. But this has not happened to date and drug companies are not regulating themselves.
True, Drugs and Cosmetics Act, 1940 regulates the manufacture, sale and distribution of drugs. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Consumer Protection Act,1986 are also in place. However, there is no law regulating the marketing and promotion of pharmaceutical companies.
The irony is a doctor’s licence can be revoked for malpractice because of their relationship with a pharma firm. However, the law is one-sided as the drug firms that indulge in malpractice are exempt from the purview of that law.
The Indian Medical Council (Professional Conduct, Etiquette and Ethics) regulation was brought in 2002. This barred
doctors from getting gifts, travel facilities, cash or other monetary benefits, etc from pharmaceutical companies. Sometimes, doctors are subject to litigation under it, but pharma firms get away scot-free.
Experts say there is a need for a strict law that not only curbs unethical practices like these but also gives them severe punishment for playing with the health of the people. A common law that prevents and prohibits bribery in the private sector may be in order. Another option could be to have special laws or provisions to prevent the corruption of pharma companies.
These laws have been very effective in the US, France, Germany, Hungary, Italy, and the UK. Criminal cases have been filed against pharma companies and heavy fines have been imposed on them. In 1996, a doctor was indicted for a heart valve scandal in Germany. In 2009, a big firm like Johnson & Johnson was fined $2.2 billion. In addition, in 2013, Pfizer was fined $2.3 billion to settle civil and criminal charges. GlaxoSmithKline paid a fine of 3 billion euros in 2014, in which four officials went to jail. In 2018, Pfizer had to pay a US$23.85 million fine for bribery in India.
A study found that seven major pharma companies spent a total of Rs 34,000 crore on marketing in eight years. This increased the price of the drug significantly. Sales promotions account for about 20% of the cost of the drug as well.
No wonder, say some experts, retail medicines worth Rs 42,000 crore were sold in a year. Approval for over 290 fixed-dose combination drugs was taken back earlier. However, over 100 such combinations again became available in the market with the permission of the Drugs Controller General of India. It is high time, India has a strict law in this regard.
(The author is a senior journalist and a well-known political commentator)